A randomized controlled trial (RCT) of telerehabilitation on exercise capacity, physical activity and quality of life in people with Chronic Obstructive Pulmonary Disease (COPD): The TeleR study. Ling Ling Tsai, Faculty of Health Sciences
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Semelhante a A randomized controlled trial (RCT) of telerehabilitation on exercise capacity, physical activity and quality of life in people with Chronic Obstructive Pulmonary Disease (COPD): The TeleR study. Ling Ling Tsai, Faculty of Health Sciences
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A randomized controlled trial (RCT) of telerehabilitation on exercise capacity, physical activity and quality of life in people with Chronic Obstructive Pulmonary Disease (COPD): The TeleR study. Ling Ling Tsai, Faculty of Health Sciences
- 1. A randomised controlled trial (RCT) of telerehabilitation on exercise capacity, physical activity and quality of life in people with Chronic Obstructive Pulmonary Disease (COPD): The TeleR study Tsai LL1, 2, Moddel C3, McKeough ZJ2, McNamara RM1,2, McKenzie DM1, Alison JA2, 4 Prince of Wales Hospital, Randwick 1 2 Clinical Rehabilitation Services, The University of Sydney, Lidcombe 3 4 NSW Agency for Clinical Innovation Royal Prince Alfred Hospital, Camperdown
- 2. Background Pulmonary Rehabilitation (PR) in people with COPD: › < 1% who could benefit currently have access to PR (LFA, 2008) › Barriers to attendance at PR include: - difficulty accessing program venue due to poor mobility - lack of transport - cost of travel (Keating et al, 2011) › Telerehabilitation (TR) could overcome the above barriers › PR delivered from an expert rehabilitation centre to smaller, regional centres via videoconferencing showed equivalent outcome for exercise capacity and quality of life (Strickland et al, 2011) › No studies have evaluated the outcomes of TR in COPD using randomised controlled trial (RCT) methodology
- 3. Aim › Primary Aim: - To determine the effect of an 8 week TR exercise program on exercise capacity vs. no rehabilitation (NR) in COPD › Secondary Aims: - To determine the effect of TR on physical activity, functional performance, quality of life, symptoms and self-efficacy vs. NR - To determine compliance with rehabilitation and participant satisfaction with the technology used in delivering TR program 3
- 4. Method & Study design Study Design Prospective RCT & single assessor blinding Recruitment & Assessment ISWT’s, ESWT’s, 6MWT’s, SWA, CRDQ, Pulmonary Function Testing Randomisation 1:1 Telerehabilitation group (TR) 8 weeks supervised walking, cycling, functional exercises at home 3xdays/wk, Unsupervised home program 2xdays/wk No rehabilitation group (NR) 8 weeks usual medical care with no exercise training Blinded re-assessment 4
- 5. Outcome Measures •Endurance Shuttle Walk Test _ (ESWT) •Incremental Shuttle Walk Test _ (ISWT) •Six Minute Walk Test (6MWT) Physical Activity Level: SenseWear MF armband •Quality of Life •Self-Efficacy •Patient Satisfaction •Symptoms of Dyspnoea, Anxiety & Depression 5
- 6. Supervised TR Intervention Walking 15-20 mins Cycling 15-20 mins Functional Exercises: Sit to Stand & Squats 6
- 7. Intervention Videoconferencing (Vsee) with TR participant www.vsee.com Physiotherapist monitoring patient remotely while exercising 7
- 8. Data Analysis & Results › Data Analysis: - Repeated measures ANOVA or ANCOVA (if baseline differences) via SPSS › Current Results: - 6 recruited - 3 in telerehabilitation group (TR) - 3 in control group with no rehabilitation (NR) › Funding support: - NSW Agency for Clinical Innovation (ACI) - SESLHD Chronic Care Service Redesign Grant 2012 8
- 9. Potential Future Collaboration › Rural and remote sites › Multi-centred throughout Australia › Other chronic disease groups (e.g. heart failure) › Contact details: Ling Ling Tsai: lingling.tsai@sesiahs.health.nsw.gov.au - Senior respiratory physiotherapist at Prince of Wales Hospital & PhD candidate at The University of Sydney Zoe McKeough: zoe.mckeough@sydney.edu.au - Senior Lecturer at The University of Sydney 9
- 10. Potential Future Collaboration › Rural and remote sites › Multi-centred throughout Australia › Other chronic disease groups (e.g. heart failure) › Contact details: Ling Ling Tsai: lingling.tsai@sesiahs.health.nsw.gov.au - Senior respiratory physiotherapist at Prince of Wales Hospital & PhD candidate at The University of Sydney Zoe McKeough: zoe.mckeough@sydney.edu.au - Senior Lecturer at The University of Sydney 9
Notas do Editor
- Over 13% of the Australian population suffers from COPD costing approximately $800 million annually1. Strong evidence from RCTs suggests pulmonary rehabilitation (PR) reduces breathlessness and increases exercise capacity in COPD2. The Lung Foundation Australia estimates less than 1% of COPD people who could benefit currently have access to PR3, which is grossly inadequate. Barriers to attendance at PR include difficulty getting to the program venue due to poor mobility, lack of transport and cost of travel4. Telerehabilitation, the delivery of rehabilitation services via communication technologies, is one way to overcome these barriers. No studies have evaluated the outcomes of telerehabilitation in COPD using RCT methodology. A large controlled trial (n = 409) has shown that a pulmonary rehabilitation program delivered from a large, expert rehabilitation center to smaller, regional centers via videoconferencing resulted in equivalent outcomes for exercise capacity and quality of life (690). Stickland M, Jourdain T, Wong EY, Rodgers WM, Jendzjowsky NG, Macdonald GF. Using telehealth technology to deliver pulmonary rehabilitation in chronic obstructive pulmonary disease patients. Can Respir J 2011;18:216–220. Keating A et al: What prevents people with chronic obstructive pulmonary disease from attending pulmonary rehabilitation? A systematic review. Chronic Respiratory Disease 2011, 8: 88-89 Keating A et al: Lack of perceived benefit and inadequate transport influence uptake and completion of pulmonary rehabilitation in people with chronic obstructive pulmonary disease: a qualitative study. Journal of Physiotherapy 2011, Vol57: 183-190
- computer-generated MINIM software with concealed allocation
- Three field-based walking tests: Incremental Shuttle Walk Test (ISWT): The ISWT to peak exercise capacity will be performed over a 10 metre course (Sing 1992). This test is externally paced with work rate (i.e. velocity) increasing each minute. Two tests on two separate days will be performed. Rationale: This test will be used to measure changes in peak exercise capacity. Peak velocity achieved in the ISWT will be used to determine the velocity for the ESWT and to set the initial walking training intensity. Endurance Shuttle Walk Test (ESWT): The ESWT will be performed on the same track as the ISWT at a velocity equivalent to 85% of the participant’s peak velocity achieved on the ISWT until voluntary task failure or 20 minutes is reached (Revill 1999). Two tests on two separate days will be performed. Rationale: This test will be used to measure endurance exercise capacity. Six-Minute Walk Test (6MWT): This is a self-paced walking test. Two tests on two separate days will be performed. Rationale: There is evidence that the 6MWT is a reliable and valid measure of functional exercise capacity in people with COPD (Pitta 2005). Physical Activity Levels: Functional Performance Inventory – Short Form (FPI – SF): The FPI-SF is a self-administered questionnaire designed to evaluate functional performance in patients with COPD. Rationale: The instrument is reliable and valid (Leidy NK, 2010). It is designed to quantify patient-reported functional performance in COPD in six domains including body care, maintaining the household, physical exercise, recreation, spiritual activities and social interactions. Sensewear Armband: Participants will be provided with instructions - please see attached “Armband Instructions for Use” in “Telerehabilitation Education Booklet” for further details. The armband will be set to the participant’s weight, height and age. Each armband has a built-in facility to monitor compliance of the participant, then all the information will be downloaded onto the software by the researcher. It will detect when the armband has been removed and applied. If another person wore the armband the data would be inappropriate as the armband relies on the correct input of height, weight and age information. Sensewear Armband (Dwyer, 2009; Patel, 2007; Hill, 2009; Hill, 2010) is a TGA approved device. Please find attached document for approval. Rationale: Monitoring physical activity through FPI – SF questionnaire and the activity monitor provides comprehensive information on the physical activity level of participants and whether this changes with Telerehabilitation. Five quality of life questionnaires: Chronic Respiratory Disease Questionnaire (CRDQ): This assessment tool has been reported to be valid, sensitive and responsive in people with COPD. This assessment tool reports on dyspnoea, fatigue, emotional function and mastery (Lacasse Y, 2009). Modified Medical Research Council dyspnoea scale (MMRC): This assessment tool has been reported to have acceptable reliability, provide consistent values, and be able to differentiate between different clients. It is a valid measure that has a strong relationship with mortality rate (Darbee, 2006). Hospital anxiety and depression scale (HADS): There is evidence that people with COPD have a high level of anxiety and depression and HADS has been shown to be a valid outcome measurement tool in this population (Dawson, 2001). We will measure both anxiety and depression to examine the impact of anxiety and depression on physical activity. COPD Assessment TestTM (CAT): There is a study which has concluded that the CAT can detect COPD health status which is related to exercise capacity (Jones, 2010). Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE): This tool will measure the effect of telerehabilitation on self-efficacy. It has been shown to be a reliable and sensitive measure of self-efficacy in people with COPD (Vincent et al 2011). Patient Satisfaction Questionnaire: Client Satisfaction Questionnaire 8 (CSQ-8): This is a validated and reliable questionnaire which has been widely used in assessing services provided (Laresen, 1979).
- In the TG group, training will run for a total of eight weeks, twice a week for one hour. The session will include aerobic exercises utilising cycle ergometry and walking training. The initial intensity, duration and frequency of the participant’s exercise program will be prescribed by the assessor (RM) following the initial assessments. The primary researcher (LLT) will be conducting all TG training sessions. During the hourly training session participants will be asked to perform a total of 30 minutes of aerobic training including 15 minutes on the cycle ergometer and 15 minutes walking. Participants will be monitored via collection of oxygen saturation (SpO2), Heart Rate, Borg Dyspnoea Score and Rate of Perceived Exertion (RPE) at the start of the sessions, seven minutes into cycle ergometer training session and seven minutes into the walking training session as well as at the end of each session. Oxygen saturation (SpO2) and heart rate will be monitored by using the finger tip oximeter provided to participants. Exercise intensity, duration and frequency will be progressed and recorded during the eight weeks of TG training according to the Borg Dyspnoea Score and Rate of Perceived Exertion (RPE) readings obtained during the sessions in order to maintain a Borg Dyspnoea Score of Moderate to Somewhat Severe (Score 3-4) and Rate of Perceived Exertion of Moderate to Somewhat Severe (Score 12-13). The primary researcher (LLT) will remain in contact with the participants for the duration of the trial and will be responsible for trouble-shooting any problems as they arise. A physiotherapist will only be visiting participants before the first session of the project to set up the cycle ergometer and laptop computer and at the end of the eight week training period to collect the cycle ergometer and laptop computer. Participants will be instructed clearly that physiotherapists will not be doing home visits unless there is a technical issue that cannot be resolved over the phone or during the videoconferencing session. The number of participants receiving the Telerehabilitation at the same time will range from 2 to 4 participants.
- Data analyses will be conducted using SPSS. Data will be presented as mean (SD) unless stated otherwise and intention to treat analysis will be used. All outcome measures will be analysed using repeated measures ANOVA and unpaired t-tests. A p-value of 0.05 (2-sided) will be taken as the level of significance. The 95% confidence intervals around the mean differences between groups will also be calculated. However, if baseline measurements influence post-intervention outcomes then we will use analysis of covariance (ANCOVA) for the between group comparisons with pre-intervention values as the covariate.