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Completed

NCT Number: NCT05043428

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University

Montreal, Quebec, H3A 0G4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Performance in activities of daily and social living

    Time frame: Baseline, 8 and 12 weeks

    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.

Secondary outcomes

  1. Timed "Up & Go" test

    Time frame: Baseline, 8 and 12 weeks

    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.

  2. 1-minute sit-to-stand test

    Time frame: Baseline, 8 and 12 weeks

    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.

  3. Handgrip Test

    Time frame: Baseline, 8 and 12 weeks

    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.

  4. Borg Scale - Dyspnea

    Time frame: Baseline, 8 and 12 weeks

    On a scale from 0-10, participants' indicate their breathlessness level. 0- No breathlessness at all to 10- Maximal breathlessness

  5. Godin Leisure Time Physical Activity Questionnaire

    Time frame: Baseline, 8, and 12 weeks

    Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.

  6. The Psychological Need Satisfaction in Exercise scale

    Time frame: Baseline, 8, and 12 weeks

    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.

  7. The Treatment Self-Regulation Questionnaire

    Time frame: Baseline, 8, and 12 weeks

    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.

  8. Social Support from Peer Support Group Questionnaire

    Time frame: 8 and 12 weeks

    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.

  9. Medical Research Council Questionnaire on Breathlessness (mMRC)

    Time frame: Baseline, 8, and 12 weeks

    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.

  10. COPD Assessment Test (CAT)

    Time frame: Baseline, 8, and 12 weeks

    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.

Other outcomes

  1. Activities, Healthcare, and Research Priorities Survey

    Time frame: Baseline, 8, and 12 weeks

    Participants will answer 26 questions based on daily and social activities and be asked if they participate in said activity. Responses include: Yes - as much as I want. Yes - but less than I want. No - but I would like to do it. No - and I don't want to do it.

  2. Three Factor Social Identity Questionnaire

    Time frame: 8, and 12 weeks

    This 7 point scale measures feelings about being a part of the exercise and peer support group. 1-strongly disagree and 7- strongly agree to indicate agreement with each of the statements.

  3. The Acceptability of Intervention Measure (AIM)

    Time frame: 8, and 12 weeks

    The Acceptability of Intervention Measure will be administered to measure high acceptability and satisfaction with the intervention. Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.

  4. Intervention Appropriateness Measure (IAM)

    Time frame: 8, and 12 weeks

    The Intervention Appropriateness Measure will be administered to measure high acceptability and satisfaction with the intervention. Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.

  5. Feasibility of Intervention Measure (FIM)

    Time frame: 8, and 12 weeks

    The Feasibility of Intervention Measure will be administered to measure high acceptability and satisfaction with the intervention. Using a 5 point scale, participants will answer 8 questions and rate them as 1- Completely disagree to 5- Completely agree.

  6. 6-Item Health Care Climate Questionnaire

    Time frame: 4, 8, and 12 weeks

    This 7 point scale measures how strongly the participant experienced interest, intrigue, focus, enjoyment, and annoyance during their participation in he Functional Tasks and Peer Support Intervention. 1-not at all experienced during the intervention to 7-extremely experienced during the intervention.

  7. Behaviour Change Technique Usage Questionnaire

    Time frame: baseline, 8, and 12 weeks

    Participants completed a questionnaire that asked them to rate on a scale from 1 (not once) to 5 (daily) how frequently they have used goal setting, action planning, coping planning, physical restructuring, self monitoring, values identification, social restructuring, resource finding, and self belief in the past two weeks,

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Fondation Québécoise en Santé Respiratoire

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2021
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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