The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD

Study Overview
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Brief Summary
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This study aims to evaluate the effects of an online exercise and peer support intervention for people living with COPD. In the framework of a randomized control trial, 24 adults with COPD will be recruited to participate in the study and will be randomly assigned to either the control or intervention group. The control group will participate in an 8-week virtual program based on the exercise component of a standard home-based pulmonary rehabilitation program (one online consultation and 7 phone calls with a kinesiologist). The intervention group will participate in a twice a week online intervention that includes an exercise component based on individuals' activities of daily living and a peer support component where individuals will be taught and encouraged to discuss behaviour change techniques that have been shown to help support increased participation in physical activity and/or exercise. The goal of this study is to determine the efficacy of the novel online exercise intervention and whether the benefits are above other intervention options.

Official Title
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The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD: a Pilot Randomized Controlled Trial

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Behavioral: The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a COPD diagnosis, be medically able to participate in exercise (confirmed by healthcare professional in the past 2 years), have access to a computer with a camera and internet, speak English or French, and have the intention to become physically active in the next 2 months or have been minimally active (<150 minutes per week) in the past 2 months Exclusion Criteria: less than 18 years of age, diagnosed with a cognitive impairment, not diagnosed with COPD by a medical professional, unable to participate in exercise or unconfirmed in the past 2 years from a medical professional, no access to a computer and internet.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A convenience sample of adults living with COPD (N=22) will be recruited to participate in an 8-week online exercise intervention. The objective is to test a two-arm pilot randomized controlled trial (RCT) for individuals living with COPD and to determine whether the intervention can improve individuals' performance in activities of daily and social living.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Those randomized to the intervention group will be asked to attend 16 online sessions (2 session/week). Each session will last one hour (total time: 16 hours. The exercise portion will be approximately 30 minutes of each session and led by a certified kinesiologist. These exercises are based on activities related to your daily life. As well, they will take part in peer support sessions. The peer support session will be approximately 30 minutes and be moderated by a behaviour change specialist who will also provide strategies to be active. In this peer support group, particpants will share and learn from other individuals living with COPD to help you stay active during and after the intervention. The online sessions will be video recorded to make sure that the program is delivered as designed. | Behavioral: The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial<br>* An 8 week two-arm pilot randomized control trial aimed to evaluate the effects of an online exercise and peer support intervention for people living with COPD.<br>|
| Active Comparator: Control Group<br>Those randomized to the control group will be asked to participate in an 8-week exercise program based on the exercise component of a standard home-based pulmonary rehabilitation program. During week 1 of the program, participants will receive a videocall via Microsoft Teams from the certified kinesiologist who will prescribe an exercise program, supervise the first exercise session, and provide a copy of Living Well with COPD, a list of strength exercises, and a home exercise diary. In weeks 2-8, participant exercises will be performed offline, on their own. Participants will be encouraged to engage in two or more exercise sessions per week, targeting both aerobic capacity and muscular strength, and document their exercise using a home diary. They will also receive a phone call once a week from the certified kinesiologist to discuss their exercise progress. | Behavioral: The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial<br>* An 8 week two-arm pilot randomized control trial aimed to evaluate the effects of an online exercise and peer support intervention for people living with COPD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance in activities of daily and social living | Participant goal participation will be measured by improvement in initial goals set at the beginning of the study using the Canadian Occupation Performance Measures (COPM). Success will be determined by calculating individuals change score on their satisfaction with their performance in their target areas post-intervention. A change score of 2 on an item is said to represent significant change (Law et al., 2000). A change score of at least 2 on 50% of items (dependent on personal goals) for 70% of participants will be the indicator of success. | Baseline, 8 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up & Go test | This test measures the time it takes an individual to stand from a standard chair (approximately 46cm), walk 3 metres, walk back, and return to sit on the chair (Podsiadlo & Richardson, 1991). The participant is timed from when the leave the seat to when they are seated again. A time of >30 seconds is the cut-off for safe unsupervised participation (Podsiadlo & Richardson, 1991). Anyone who gets a time >30seconds will be informed that they cannot participate. | Baseline, 8 and 12 weeks | 
| 1-minute sit-to-stand test | The 1-minute sit-to-stand test is a measure of exercise capacity that has been validated with individuals living with COPD (Puhan et al., 2013). Individuals sit on a standard chair without arm rests, with their legs hip-width apart and about 90 degrees knee flexion and aligned and are asked to hold their hands stationary on their hips. Participants are then asked to stand and sit 1-2 times to familiar themselves with the movement. Then, for the duration of 1 minute, participants are asked to do as many repetitions as possible of the sit to stand, without using arms for support. The number of repetitions is recorded. | Baseline, 8 and 12 weeks | 
| Handgrip Test | To measure handgrip strength, we will use a Hand Dynamometer that will be sent to participants. Individuals sit with their shoulders adducted, elbows flexed to 90˚ and forearms in a neutral position (Puhan et al., 2013). They are then asked to squeeze the handle as much as possible and read to the nearest kilogram where the needle stopped, which is then recorded. The best of six measurements is used as an indication of upper body strength. | Baseline, 8 and 12 weeks | 
| Borg Scale - Dyspnea | On a scale from 0-10, participants' indicate their breathlessness level. 0- No breathlessness at all to 10- Maximal breathlessness | Baseline, 8 and 12 weeks | 
| Godin Leisure Time Physical Activity Questionnaire | Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency. | Baseline, 8, and 12 weeks | 
| The Psychological Need Satisfaction in Exercise scale | This 1-6 scale represents different feelings people have when they exercise. 1-true to how they typically feel when exercising, and 6-false to how they typically feel when exercising. | Baseline, 8, and 12 weeks | 
| The Treatment Self-Regulation Questionnaire | This 7 point scale relates to the reasons why one would either start to exercise regularly or continue to do so. 1- not at all true to the reason why they would exercise regularly, and 7- Very to true to the reason why they would exercise regularly. | Baseline, 8, and 12 weeks | 
| Social Support from Peer Support Group Questionnaire | This 4 point scale measures how often during the past 4 weeks peers (i.e. other people with COPD) have provided informational and emotional support to the participant. 1- Never provided the support described and 4- Very often provided the support described. | 8 and 12 weeks | 
| Medical Research Council Questionnaire on Breathlessness (mMRC) | This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness. | Baseline, 8, and 12 weeks | 
| COPD Assessment Test (CAT) | This questionnaire was used to measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease. | Baseline, 8, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, peer support, behavior change