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Social and Behavioral Factors
Predicting Healthy Aging: the
Roles of Socioeconomic Status
     and Physical Activity

      Jack M. Guralnik, M.D., Ph.D.

      Laboratory of Epidemiology,
       Demography and Biometry
     National Institute on Aging, NIH
Death Rates (Per 100,000) for Six Leading Causes
               of Death, Age 65+, U.S.
                                                                        Percent
                                                                        Change
                                                                         1980-
                                 1980        1990          2004          2004

 Heart Disease                   2,629       2,092         1,537          -41.6

 Cancer                          1,052       1,142         1,112           +5.7

 Stroke                           669         449           376           -43.8

 COPD                             179         245           303            69.3

 Diabetes                         107         120           155            44.9

 Pneumonia/                       214         258           152           -29.0
 Influenza

Source: National Vital Statistics System Rates age-adjusted using 2000 standard population
Probability of Dying Between Age 45 and 65
    Comparing Men in Manual versus Non-Manual Occupations
                                                                  Absolute manual vs. non-
Country                      Probability of dying (%)                manual difference
                   National       Non-manual            Manual
                  population          classes           classes
Finland             24.0                18.9              28.8             9.8
Sweden              16.4                14.1              19.7             5.6
Norway              18.0                15.7              20.9             5.2
Denmark             21.0                19.1              25.4             6.3
England/Wales       20.3                16.5              24.0             7.5
Ireland             23.1                21.0              29.1             8.1
France              21.3                16.2              27.6             11.5
Switzerland         16.7                14.5              19.5             5.0
Italy               20.8                18.5              24.6             6.0
Spain               18.1                15.2              21.1             5.8
Portugal            21.0                16.4              22.5             6.1



Source: Kunst et al. Soc Sci Med 1998;46:1459-76.
Probability of Dying Between Ages 15 and 59
Mortality and Education in Men Aged 45–90 years in Matlab, Bangladesh
                               1982–98




  Hurt et al. J Epidemiol Community Health 2004;58:315-320.
Educational Inequalities* for Major Causes of Death in Men
                                 Europe, 1990 – 1997

                              ≥45 year                           ≥75 years
                    Rate ratio    Rate difference†     Rate ratio   Rate difference†
IHD                    1.3              148               1.1             312
CVD                    1.3                78               1.2            264
Lung cancer            1.7               106               1.4            168
COPD                   2.0                95               1.8            335

Total mortality        1.3               796               1.2           2127

* Pre-primary, primary, lower secondary vs. upper secondary and post-secondary
†
  Difference in deaths per 100,000 population.

Source: Huisman et al. Lancet 2005; 365:493-500.
Life Expectancy
The average number of years of remaining life for
an individual who is a specific age

Active Life Expectancy
The average number of years of remaining life
which is disability-free for an individual who is a
specific age

Disabled Life Expectancy
The average number of years of remaining life
with disability for an individual who is a
specific age
TRANSITIONS TO CONSIDER WHEN
 COMPUTING ACTIVE LIFE EXPECTANCY

       BASELINE             STATUS AT ONE YEAR

                            REMAIN DISABILITY-FREE

INITIALLY DISABILITY-FREE   DISABLED

                            DIE


                            REMAIN DISABLED

INITIALLY DISABLED          NON- DISABLED

                            DIE
Total Life Expectancy, Active Life Expectancy
               and Disabled Life Expectancy
             Piedmont Health Survey of the Elderly; Women, Age 65
                                                                                 Total Life
                                                                                Expectancy
 White Women
    Low Education                    15.2                    2.6                  17.8

    High Education                      18.0                        3.0           21.0


 Black Women
    Low Education                    15.6                     2.7                 18.3

    High Education                          19.5                          3.3     22.8

                     0           5           10         15           20          25

                         Active life expectancy              Disabled life expectancy


Source: Guralnik, et al. New Engl J Med 1993;329:110.
Americans who had not graduated from high school had a death
rate two to three times higher than those who had graduated from
college. This gap in mortality between the relatively advantaged
and the disadvantaged is very large -- larger than the gap due to
many other well-known risk factors, including cigarette smoking,
and it has been growing wider.

                Marcia Angell, NEJM 1993:329:126-127
Proportion Surviving from Age 26 to 54 Years by Father’s
   Social Class in 4271 Persons Born in March 1946
                                          (Total Deaths = 201)

                           1
                         0.99
      Proportion alive



                         0.98
                                                                           Non-manual
                         0.97

                         0.96
                         0.95
                                                                 Manual
                         0.94
                         0.93
                                26   30    34    38     42   44      48     52

                                                  Age
                                                                          Kuh et al, BMJ 2002
Low and High Function at Age 53
           British 1946 Cohort Study
• Aggregation of standardized scores on three tests
   – Grip strength
   – Single leg stand for up to 30 seconds
   – Time to rise from chair 10 times
• Low function defined as lowest 10% of aggregate
  score
• High function defined as highest 10% of aggregate
  score
Distribution of Summary Performance Score
          8




          6
Percent




          4




          2




          0
                    .5     1           1.5          2     2.5   3

                          Sum of continuous test scores
Figure 2. Self-Report of Disability and Falls in Persons with Poor, Middle,
        and High Performance. Weighted to adjust for sampling.


  Difficulty walking 1/4
            mile

  Difficulty walking up
    and down stairs

     Difficulty gripping

                                                   Performance at age 53
 Falls or poor balance                                      Poor
                                                            Middle
      1-2 fall past year                                    High


     3+ falls past year
                           0

                           0   10   20     30      40      50        60

                                         Percent
Relative Risk (95% CI) for Poor and High Function at Age 53
          According to Childhood Social Factors
                                             British 1946 Cohort Study

                            2.0


                                                    High                              High
    Relative Risk (95%CI)



                            1.5
                                                  Function                           Function


                            1.0



                             .5
                                   Poor                           Poor
                                  Function                       Function

                             0
                                       Adjusted for Sex        Adjusted for Sex and Adulthood risk factors
                                                                (smoking, exercise, BMI, Alcohol intake)


                              Father’s Occupation (Manual vs. Non-manual)
.                             Mother’s Education (Primary vs. Secondary)
Percent of Participants with Poor and High Function According to Mother’s
     Education and Father’s Occupation when Participant was Age 4.
                       Weighted to adjust for sampling

          18                                     18
                     Poor function                              High function
          16                                     16

          14                                     14

          12                                     12
Percent




          10                                     10

           8                                         8

           6                                         6

           4                                         4

           2                                         2

           0                                         0
               Primary          Secondary                 Primary           Secondary
                  Mother’s Education                         Mother’s Education

                  Father’s Occupation       Manual       Non-manual
Gait Speed (400-m) According to Education Level,
                                Age Group, and Gender
                                            InChianti Study
                   1.6


                   1.4


                   1.2
Gait Speed (m/s)




                    1
                                                                                   Years of
                   0.8                                                             Education
                                                                                     <= 5 years
                   0.6
                                                                                     > 5 years
                   0.4


                   0.2


                    0
                         65-74   75-84   85 +               65-74   75-84   85 +
                                                Age Group

                                 Men                                Women
Mean Walking Speed (95% Confidence Intervals) by
              Employment Grade and Sex
                                    Adjusted for Age and Ethnicity
                                          Whitehall II Study

                      1.5
                                        trend P<0.001 both sexes
Walking speed (m/s)


                      1.4

                      1.3                                                                       Men
                      1.2                                                                     Women
                      1.1

                       1
                            Admin 1 Admin 2   SEO        HEO       EO       Clerical
                                      Last known employment grade




                                                        Brunner et al. J Gerontol Med Sci 2009;64:1082-9.
We are all wearing out but poor
people wear out faster than rich
people.

How can we modify health
disparities?
Physical Activity and Disability in
         Older Persons:

  Moving From Observational
  Studies to Clinical Trials of
     Disability Prevention
Risk Factors for Disability
• Low physical activity
• Smoking
• High and low body mass index, weight
  loss
• Heavy and no alcohol consumption
• High medication use
• Poor self-rated health
• Reduced social contacts



Source: Stuck et al., Soc Sci Med 1999;48:445-469
DHHS Physical Activity Guidelines
       Advisory Committee Report, 2008
            Functional Health Chapter

Review of observational studies:
• Active mid-life and older individuals have
  approximately a 30% lower risk of developing
  moderate or severe functional limitations or role
  limitations compared with inactive individuals.
• Results strongly consistent across studies
• No large RCTs and data cannot prove causality of
  effect

                  http://www.health.gov/PAguidelines/Report/Default.aspx
Maintaining Mobility in Late Life
      Established Populations for the Epidemiologic
               Study of the Elderly (EPESE)
                                 Study Design
                                                            Maintained
                                                            mobility
                                                            3847 (53%)
                                                            Loss mobility
                                              Four annual   2526 (35%)
Baseline                                       followups
                        Mobility
 10,048
                      7227 (72%)                            Died - no
screened
                                                            mobility loss in
                                                            prior interviews
                                                            608 (8%)
                    Mobility-related                        Missing data
                      disability                            246 (3%)
                     2821 (28%)


  Source: Guralnik et al. Am J Epidemiol 1993;137:845-857
Physical Activity and Incident Mobility Loss
                1.5
                                                                         Men
                                                                         Women


                1.0
Relative Risk
 of Loss of
 Mobility**

                0.5




                0.0
                                   Low                 High
                                      Physical Activity*

   *Summary measure including walking, gardening, and vigorous activity.
  **Adjusted for age, number of chronic conditions, body mass index, smoking and alcohol consumption.

  Source: LaCroix et al. Am J Epidemiol 1993;137:858-869.
Change in SPPB Score Over One Year
                                   by Baseline Walking Category
                                      Women’s Health and Aging Study
Mean change in summary




                                   P=.001         P=.023        P=.012
  performance score




                           0                                              Walkers
                         -0.2                                             Non-walkers
                         -0.4
                         -0.6
                         -0.8
                                   Model 1       Model 2        Model 3




Source: Simonsick et al. J Am Geriatr Soc 2005;53:198-203.
Could the Evidence for the Benefits of Exercise
   be Overstated by Longitudinal Studies?
•   Other habits of exercising older adults may be operative
       (Confounding)

•   Good health permissive of exercise
       (Reverse Causality)

•   Reporting bias
        (Non-differential misclassification)

•   Data don’t directly address the public health intervention
    under consideration
        (Continuation versus Initiation)


                                         Source: Kritchevsky 2009
Why is a clinical trial needed to demonstrate
     that exercise prevents disability?

• Can improve impairments such as weakness and
  poor balance
• These impairments have been shown in
  observational studies to predict disability
• However, it is unknown whether treating impairments
  will lead to prevention of disability
   - Underlying condition that caused muscle
     weakness may also go on to cause disability, even
     if muscle strength improved by intervention
Lifestyle Interventions and
   Independence For Elders
A Randomized Clinical Trial of Exercise to
 Prevent Mobility Disability in   Non-
 disabled Older Persons with Functional
              Limitations
Potential public health impact is high:

 • Discrete, easily understood outcome
   (walking 400 meters)
 • Intervention that is practical and
   potentially cost effective
 • Supports evidence based medicine for
   physicians to prescribe this intervention
Why a mobility intervention?

• Mobility a fundamental component of:
   - Self-care – ADL’s
   - IADL’s
   - Independence in the community
• Focused intervention with clear endpoint
• Practical to power study compared to less
  common endpoints
Older people who maintain mobility:

• Remain in the community
• Have lower rates of subsequent morbidity
  and mortality
• Have higher quality of life
• Have lower health care costs and utilization
• Can walk for exercise
Overview of Study Design – LIFE-P
•   Multicenter single-blind pilot RCT
    – Pittsburgh, Wake Forest,
       Cooper Institute, Stanford
•   Physical exercise vs. successful aging health
    education program
•   400 non-disabled, community-dwelling
    sedentary persons age 70-89 years who are at
    risk of disability
•   Follow-up: one to two years
•   Outcome: Short Physical Performance Battery
    (SPPB) Score
Short Physical Performance Battery


  Timed standing balance (up to 10 seconds)
    Side-by-side stand

          Semi-tandem stand

                       Tandem stand
  Timed 4-meter walk
  Timed multiple (5) chair rises
Disability Status at Four Years According to Baseline Summary
  Performance Score Among Those Non-Disabled at Baseline
                                    Iowa EPESE

           100



            80                                                    Non-
                                                                  disabled
                                                                  Mobility
            60                                                    Disability
 Percent




                                                                  ADL
            40                                                    Disability



            20



             0
                 4   5     6    7      8   9     10   11     12
                         Summary Performance Score

    Source: Guralnik et al. N Engl J Med 1995;332:556-561.
Age and Sex-Adjusted Proportion of Participants Unable to Complete 400 Meter
             Walk at 3-Year Follow-Up by Baseline SPPB Score
                                                                             InChianti Study



            Unable to walk 400m after three years (%)
                                                        90


                                                        80


                                                        70


                                                        60                                          p for trend <0.001

                                                        50


                                                        40


                                                        30


                                                        20


                                                        10


                                                         0
                                                             <7        8          9        10            11              12
                                                                           Baseline SPPB Score

        n                                                    18       18         40            47         126            284


                                                                  Source: Vasunilashorn et al. J Gerontol Med Sci, 2009;64:223-9 .
LIFE Study Goals vs. Actual Enrollment
             All Clinics


                     Enrollment
                                   Recruitment
                         %
                    (Frequency)       Goal

SPPB Score <= 7 41.5% ( 176)          40%

Ethnic Minorities   25.2% ( 107)      25%

Men                 31.1% ( 132)      30%
Physical activity intervention
   Center-based in a group setting with a
systematic transition to home-based exercise

 I. Aerobic (walking)
 II.Strength (lower extremities)
 III.Balance
 IV.Flexibility stretching
 V.Behavioral counseling (group
    and telephone)
Aerobic
Wake Forest U. Winston Salem, NC




      Come – Walk with us!
Aerobic

Stanford U. Palo Alto, Ca


                                    BP check




     Outdoor walking

                            Taking a break during the walk
Doing her favorite ankle
                         weight exercises
Strength

Ankle weight exercises
LIFE-P SPPB score
       10

            9             8.7
                                      8.5
    Score                                     P<0.001
            8
                          8.0
                                      7.9
                    7.5
            7
                          Physical activity
                          Successful aging
            6
                0          6 mo       12 mo
Means estimated from repeated measures ANCOVA
adjusted for gender, field center and baseline values

 J Gerontol Biol Sci Med Sci 2006;61:1157
Percent of participants who improved by >1
  point, did not change, or declined by >1 point in
  the SPPB score from baseline to 6 and 12 mos.
              6 month      12 month
              P=0.004       P=0.03
       100%
                                        SPPB change
        80%                             vs. baseline
                     102          100
               133          128
        60%                             Improve >=1
                                        point
        40%          44           33
                                        No change
                            34
               31
        20%
                     56           60
               35           42          Decline >=1
        0%                              point
              PA     SA    PA     SA
NNT for improvement = 6 at 6 mos and 9 at 12 mos
NNT for preventing decline = 10 at 6 and 12 mos
    J Gerontol Biol Sci Med Sci 2006;61:1157
Conclusions
• Compared to SA, PA improved the SPPB
  score and 400 m walk speed
• Consistency among major subgroups
• Minimal loss to follow-up
• Excellent safety record
• An intervention that improves the SPPB
  performance may also offer benefit on more
  distal health outcomes, such as mobility
  disability
Definition of a successful pilot
• Recruitment of 400 participants in 9 months
• Sufficient outcome rates in the control group
• Implementation of the intervention
• Adherence to intervention after 1 year >70%
• No safety concerns from DSMB
• Favorable trends in multiple outcomes
• Loss to follow-up <2%
Cumulative hazard of time until major mobility
disability and until major mobility disability or death

                          Time until major mobility                              Time until major mobility
                          disability                                             disability or death
    Cumulative Hazard




                        0.3                                                0.3




                                                       Cumulative Hazard
                        0.2                                                0.2


                        0.1                                                0.1


                        0.0                                                0.0
                              0.0   0.5     1.0                               0.0        0.5      1.0
                                           Years since randomization




                                                      J Gerontol Biol Sci Med Sci 2006;61:1157
Overview of Study Design – Definitive Trial
  •   Multicenter single-blind pilot RCT
      – 8 sites across U.S.
  •   Physical exercise vs. successful aging health
      education program
  •   1,600 non-disabled, community-dwelling
      sedentary persons age 70-89 years who are at
      risk of disability
  •   Follow-up: 3 years
  •   Outcome: Loss of ability to walk 400 m
2008 Physical Activity Guidelines
   for Americans: All Adults

        • Avoid Inactivity
        • Do a medium amount of aerobic
          physical activity
           – 150 min moderate-intensity
           – 75 min vigorous intensity
        • More exercise will have more
          benefit
        • Do muscle strengthening 2 days /
          week


              www.health.gov/paguidelines
2008 Physical Activity Guidelines
  for Americans: Older Adults

          • If at high fall risk, do balance
            training
          • Monitor level of effort using
            relative intensity
          • Be as active as abilities and
            conditions allow
          • Understand how chronic
            conditions affect ability to be
            active


             www.health.gov/paguidelines

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Social and Behaviour factor predicting healthy aging

  • 1. Social and Behavioral Factors Predicting Healthy Aging: the Roles of Socioeconomic Status and Physical Activity Jack M. Guralnik, M.D., Ph.D. Laboratory of Epidemiology, Demography and Biometry National Institute on Aging, NIH
  • 2.
  • 3. Death Rates (Per 100,000) for Six Leading Causes of Death, Age 65+, U.S. Percent Change 1980- 1980 1990 2004 2004 Heart Disease 2,629 2,092 1,537 -41.6 Cancer 1,052 1,142 1,112 +5.7 Stroke 669 449 376 -43.8 COPD 179 245 303 69.3 Diabetes 107 120 155 44.9 Pneumonia/ 214 258 152 -29.0 Influenza Source: National Vital Statistics System Rates age-adjusted using 2000 standard population
  • 4. Probability of Dying Between Age 45 and 65 Comparing Men in Manual versus Non-Manual Occupations Absolute manual vs. non- Country Probability of dying (%) manual difference National Non-manual Manual population classes classes Finland 24.0 18.9 28.8 9.8 Sweden 16.4 14.1 19.7 5.6 Norway 18.0 15.7 20.9 5.2 Denmark 21.0 19.1 25.4 6.3 England/Wales 20.3 16.5 24.0 7.5 Ireland 23.1 21.0 29.1 8.1 France 21.3 16.2 27.6 11.5 Switzerland 16.7 14.5 19.5 5.0 Italy 20.8 18.5 24.6 6.0 Spain 18.1 15.2 21.1 5.8 Portugal 21.0 16.4 22.5 6.1 Source: Kunst et al. Soc Sci Med 1998;46:1459-76.
  • 5. Probability of Dying Between Ages 15 and 59
  • 6. Mortality and Education in Men Aged 45–90 years in Matlab, Bangladesh 1982–98 Hurt et al. J Epidemiol Community Health 2004;58:315-320.
  • 7. Educational Inequalities* for Major Causes of Death in Men Europe, 1990 – 1997 ≥45 year ≥75 years Rate ratio Rate difference† Rate ratio Rate difference† IHD 1.3 148 1.1 312 CVD 1.3 78 1.2 264 Lung cancer 1.7 106 1.4 168 COPD 2.0 95 1.8 335 Total mortality 1.3 796 1.2 2127 * Pre-primary, primary, lower secondary vs. upper secondary and post-secondary † Difference in deaths per 100,000 population. Source: Huisman et al. Lancet 2005; 365:493-500.
  • 8.
  • 9. Life Expectancy The average number of years of remaining life for an individual who is a specific age Active Life Expectancy The average number of years of remaining life which is disability-free for an individual who is a specific age Disabled Life Expectancy The average number of years of remaining life with disability for an individual who is a specific age
  • 10. TRANSITIONS TO CONSIDER WHEN COMPUTING ACTIVE LIFE EXPECTANCY BASELINE STATUS AT ONE YEAR REMAIN DISABILITY-FREE INITIALLY DISABILITY-FREE DISABLED DIE REMAIN DISABLED INITIALLY DISABLED NON- DISABLED DIE
  • 11. Total Life Expectancy, Active Life Expectancy and Disabled Life Expectancy Piedmont Health Survey of the Elderly; Women, Age 65 Total Life Expectancy White Women Low Education 15.2 2.6 17.8 High Education 18.0 3.0 21.0 Black Women Low Education 15.6 2.7 18.3 High Education 19.5 3.3 22.8 0 5 10 15 20 25 Active life expectancy Disabled life expectancy Source: Guralnik, et al. New Engl J Med 1993;329:110.
  • 12. Americans who had not graduated from high school had a death rate two to three times higher than those who had graduated from college. This gap in mortality between the relatively advantaged and the disadvantaged is very large -- larger than the gap due to many other well-known risk factors, including cigarette smoking, and it has been growing wider. Marcia Angell, NEJM 1993:329:126-127
  • 13. Proportion Surviving from Age 26 to 54 Years by Father’s Social Class in 4271 Persons Born in March 1946 (Total Deaths = 201) 1 0.99 Proportion alive 0.98 Non-manual 0.97 0.96 0.95 Manual 0.94 0.93 26 30 34 38 42 44 48 52 Age Kuh et al, BMJ 2002
  • 14. Low and High Function at Age 53 British 1946 Cohort Study • Aggregation of standardized scores on three tests – Grip strength – Single leg stand for up to 30 seconds – Time to rise from chair 10 times • Low function defined as lowest 10% of aggregate score • High function defined as highest 10% of aggregate score
  • 15. Distribution of Summary Performance Score 8 6 Percent 4 2 0 .5 1 1.5 2 2.5 3 Sum of continuous test scores
  • 16. Figure 2. Self-Report of Disability and Falls in Persons with Poor, Middle, and High Performance. Weighted to adjust for sampling. Difficulty walking 1/4 mile Difficulty walking up and down stairs Difficulty gripping Performance at age 53 Falls or poor balance Poor Middle 1-2 fall past year High 3+ falls past year 0 0 10 20 30 40 50 60 Percent
  • 17. Relative Risk (95% CI) for Poor and High Function at Age 53 According to Childhood Social Factors British 1946 Cohort Study 2.0 High High Relative Risk (95%CI) 1.5 Function Function 1.0 .5 Poor Poor Function Function 0 Adjusted for Sex Adjusted for Sex and Adulthood risk factors (smoking, exercise, BMI, Alcohol intake) Father’s Occupation (Manual vs. Non-manual) . Mother’s Education (Primary vs. Secondary)
  • 18. Percent of Participants with Poor and High Function According to Mother’s Education and Father’s Occupation when Participant was Age 4. Weighted to adjust for sampling 18 18 Poor function High function 16 16 14 14 12 12 Percent 10 10 8 8 6 6 4 4 2 2 0 0 Primary Secondary Primary Secondary Mother’s Education Mother’s Education Father’s Occupation Manual Non-manual
  • 19. Gait Speed (400-m) According to Education Level, Age Group, and Gender InChianti Study 1.6 1.4 1.2 Gait Speed (m/s) 1 Years of 0.8 Education <= 5 years 0.6 > 5 years 0.4 0.2 0 65-74 75-84 85 + 65-74 75-84 85 + Age Group Men Women
  • 20. Mean Walking Speed (95% Confidence Intervals) by Employment Grade and Sex Adjusted for Age and Ethnicity Whitehall II Study 1.5 trend P<0.001 both sexes Walking speed (m/s) 1.4 1.3 Men 1.2 Women 1.1 1 Admin 1 Admin 2 SEO HEO EO Clerical Last known employment grade Brunner et al. J Gerontol Med Sci 2009;64:1082-9.
  • 21. We are all wearing out but poor people wear out faster than rich people. How can we modify health disparities?
  • 22. Physical Activity and Disability in Older Persons: Moving From Observational Studies to Clinical Trials of Disability Prevention
  • 23. Risk Factors for Disability • Low physical activity • Smoking • High and low body mass index, weight loss • Heavy and no alcohol consumption • High medication use • Poor self-rated health • Reduced social contacts Source: Stuck et al., Soc Sci Med 1999;48:445-469
  • 24. DHHS Physical Activity Guidelines Advisory Committee Report, 2008 Functional Health Chapter Review of observational studies: • Active mid-life and older individuals have approximately a 30% lower risk of developing moderate or severe functional limitations or role limitations compared with inactive individuals. • Results strongly consistent across studies • No large RCTs and data cannot prove causality of effect http://www.health.gov/PAguidelines/Report/Default.aspx
  • 25. Maintaining Mobility in Late Life Established Populations for the Epidemiologic Study of the Elderly (EPESE) Study Design Maintained mobility 3847 (53%) Loss mobility Four annual 2526 (35%) Baseline followups Mobility 10,048 7227 (72%) Died - no screened mobility loss in prior interviews 608 (8%) Mobility-related Missing data disability 246 (3%) 2821 (28%) Source: Guralnik et al. Am J Epidemiol 1993;137:845-857
  • 26. Physical Activity and Incident Mobility Loss 1.5 Men Women 1.0 Relative Risk of Loss of Mobility** 0.5 0.0 Low High Physical Activity* *Summary measure including walking, gardening, and vigorous activity. **Adjusted for age, number of chronic conditions, body mass index, smoking and alcohol consumption. Source: LaCroix et al. Am J Epidemiol 1993;137:858-869.
  • 27. Change in SPPB Score Over One Year by Baseline Walking Category Women’s Health and Aging Study Mean change in summary P=.001 P=.023 P=.012 performance score 0 Walkers -0.2 Non-walkers -0.4 -0.6 -0.8 Model 1 Model 2 Model 3 Source: Simonsick et al. J Am Geriatr Soc 2005;53:198-203.
  • 28. Could the Evidence for the Benefits of Exercise be Overstated by Longitudinal Studies? • Other habits of exercising older adults may be operative (Confounding) • Good health permissive of exercise (Reverse Causality) • Reporting bias (Non-differential misclassification) • Data don’t directly address the public health intervention under consideration (Continuation versus Initiation) Source: Kritchevsky 2009
  • 29. Why is a clinical trial needed to demonstrate that exercise prevents disability? • Can improve impairments such as weakness and poor balance • These impairments have been shown in observational studies to predict disability • However, it is unknown whether treating impairments will lead to prevention of disability - Underlying condition that caused muscle weakness may also go on to cause disability, even if muscle strength improved by intervention
  • 30. Lifestyle Interventions and Independence For Elders A Randomized Clinical Trial of Exercise to Prevent Mobility Disability in Non- disabled Older Persons with Functional Limitations
  • 31. Potential public health impact is high: • Discrete, easily understood outcome (walking 400 meters) • Intervention that is practical and potentially cost effective • Supports evidence based medicine for physicians to prescribe this intervention
  • 32. Why a mobility intervention? • Mobility a fundamental component of: - Self-care – ADL’s - IADL’s - Independence in the community • Focused intervention with clear endpoint • Practical to power study compared to less common endpoints
  • 33. Older people who maintain mobility: • Remain in the community • Have lower rates of subsequent morbidity and mortality • Have higher quality of life • Have lower health care costs and utilization • Can walk for exercise
  • 34. Overview of Study Design – LIFE-P • Multicenter single-blind pilot RCT – Pittsburgh, Wake Forest, Cooper Institute, Stanford • Physical exercise vs. successful aging health education program • 400 non-disabled, community-dwelling sedentary persons age 70-89 years who are at risk of disability • Follow-up: one to two years • Outcome: Short Physical Performance Battery (SPPB) Score
  • 35. Short Physical Performance Battery Timed standing balance (up to 10 seconds) Side-by-side stand Semi-tandem stand Tandem stand Timed 4-meter walk Timed multiple (5) chair rises
  • 36. Disability Status at Four Years According to Baseline Summary Performance Score Among Those Non-Disabled at Baseline Iowa EPESE 100 80 Non- disabled Mobility 60 Disability Percent ADL 40 Disability 20 0 4 5 6 7 8 9 10 11 12 Summary Performance Score Source: Guralnik et al. N Engl J Med 1995;332:556-561.
  • 37. Age and Sex-Adjusted Proportion of Participants Unable to Complete 400 Meter Walk at 3-Year Follow-Up by Baseline SPPB Score InChianti Study Unable to walk 400m after three years (%) 90 80 70 60 p for trend <0.001 50 40 30 20 10 0 <7 8 9 10 11 12 Baseline SPPB Score n 18 18 40 47 126 284 Source: Vasunilashorn et al. J Gerontol Med Sci, 2009;64:223-9 .
  • 38. LIFE Study Goals vs. Actual Enrollment All Clinics Enrollment Recruitment % (Frequency) Goal SPPB Score <= 7 41.5% ( 176) 40% Ethnic Minorities 25.2% ( 107) 25% Men 31.1% ( 132) 30%
  • 39. Physical activity intervention Center-based in a group setting with a systematic transition to home-based exercise I. Aerobic (walking) II.Strength (lower extremities) III.Balance IV.Flexibility stretching V.Behavioral counseling (group and telephone)
  • 40. Aerobic Wake Forest U. Winston Salem, NC Come – Walk with us!
  • 41. Aerobic Stanford U. Palo Alto, Ca BP check Outdoor walking Taking a break during the walk
  • 42. Doing her favorite ankle weight exercises Strength Ankle weight exercises
  • 43. LIFE-P SPPB score 10 9 8.7 8.5 Score P<0.001 8 8.0 7.9 7.5 7 Physical activity Successful aging 6 0 6 mo 12 mo Means estimated from repeated measures ANCOVA adjusted for gender, field center and baseline values J Gerontol Biol Sci Med Sci 2006;61:1157
  • 44. Percent of participants who improved by >1 point, did not change, or declined by >1 point in the SPPB score from baseline to 6 and 12 mos. 6 month 12 month P=0.004 P=0.03 100% SPPB change 80% vs. baseline 102 100 133 128 60% Improve >=1 point 40% 44 33 No change 34 31 20% 56 60 35 42 Decline >=1 0% point PA SA PA SA NNT for improvement = 6 at 6 mos and 9 at 12 mos NNT for preventing decline = 10 at 6 and 12 mos J Gerontol Biol Sci Med Sci 2006;61:1157
  • 45. Conclusions • Compared to SA, PA improved the SPPB score and 400 m walk speed • Consistency among major subgroups • Minimal loss to follow-up • Excellent safety record • An intervention that improves the SPPB performance may also offer benefit on more distal health outcomes, such as mobility disability
  • 46. Definition of a successful pilot • Recruitment of 400 participants in 9 months • Sufficient outcome rates in the control group • Implementation of the intervention • Adherence to intervention after 1 year >70% • No safety concerns from DSMB • Favorable trends in multiple outcomes • Loss to follow-up <2%
  • 47. Cumulative hazard of time until major mobility disability and until major mobility disability or death Time until major mobility Time until major mobility disability disability or death Cumulative Hazard 0.3 0.3 Cumulative Hazard 0.2 0.2 0.1 0.1 0.0 0.0 0.0 0.5 1.0 0.0 0.5 1.0 Years since randomization J Gerontol Biol Sci Med Sci 2006;61:1157
  • 48. Overview of Study Design – Definitive Trial • Multicenter single-blind pilot RCT – 8 sites across U.S. • Physical exercise vs. successful aging health education program • 1,600 non-disabled, community-dwelling sedentary persons age 70-89 years who are at risk of disability • Follow-up: 3 years • Outcome: Loss of ability to walk 400 m
  • 49. 2008 Physical Activity Guidelines for Americans: All Adults • Avoid Inactivity • Do a medium amount of aerobic physical activity – 150 min moderate-intensity – 75 min vigorous intensity • More exercise will have more benefit • Do muscle strengthening 2 days / week www.health.gov/paguidelines
  • 50. 2008 Physical Activity Guidelines for Americans: Older Adults • If at high fall risk, do balance training • Monitor level of effort using relative intensity • Be as active as abilities and conditions allow • Understand how chronic conditions affect ability to be active www.health.gov/paguidelines