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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring exercise, peer support, behavior change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2021
Last Updated
February 7, 2022
Sponsor
McGill University
Collaborators
Fondation Québécoise en Santé Respiratoire
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1. Study Identification

Unique Protocol Identification Number
NCT05043428
Brief Title
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
Official Title
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Fondation Québécoise en Santé Respiratoire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
exercise, peer support, behavior change

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial
Intervention Description
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 Outcome Measure Information:
Title
Performance in activities of daily and social living
Description
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.
Time Frame
Baseline, 8 and 12 weeks
Secondary Outcome Measure Information:
Title
Timed "Up & Go" test
Description
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.
Time Frame
Baseline, 8 and 12 weeks
Title
1-minute sit-to-stand test
Description
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.
Time Frame
Baseline, 8 and 12 weeks
Title
Handgrip Test
Description
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.
Time Frame
Baseline, 8 and 12 weeks
Title
Borg Scale - Dyspnea
Description
On a scale from 0-10, participants' indicate their breathlessness level. 0- No breathlessness at all to 10- Maximal breathlessness
Time Frame
Baseline, 8 and 12 weeks
Title
Godin Leisure Time Physical Activity Questionnaire
Description
Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.
Time Frame
Baseline, 8, and 12 weeks
Title
The Psychological Need Satisfaction in Exercise scale
Description
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.
Time Frame
Baseline, 8, and 12 weeks
Title
The Treatment Self-Regulation Questionnaire
Description
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.
Time Frame
Baseline, 8, and 12 weeks
Title
Social Support from Peer Support Group Questionnaire
Description
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.
Time Frame
8 and 12 weeks
Title
Medical Research Council Questionnaire on Breathlessness (mMRC)
Description
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.
Time Frame
Baseline, 8, and 12 weeks
Title
COPD Assessment Test (CAT)
Description
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.
Time Frame
Baseline, 8, and 12 weeks
Other Pre-specified Outcome Measures:
Title
Activities, Healthcare, and Research Priorities Survey
Description
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.
Time Frame
Baseline, 8, and 12 weeks
Title
Three Factor Social Identity Questionnaire
Description
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.
Time Frame
8, and 12 weeks
Title
The Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
8, and 12 weeks
Title
Intervention Appropriateness Measure (IAM)
Description
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.
Time Frame
8, and 12 weeks
Title
Feasibility of Intervention Measure (FIM)
Description
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.
Time Frame
8, and 12 weeks
Title
6-Item Health Care Climate Questionnaire
Description
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.
Time Frame
4, 8, and 12 weeks
Title
Behaviour Change Technique Usage Questionnaire
Description
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,
Time Frame
baseline, 8, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shane Sweet, Ph.D
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 0G4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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