Pulmonary Disease, Chronic ObstructiveNCT05043428
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
A study of Pulmonary Disease, Chronic Obstructive, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD: a Pilot Randomized Controlled Trial
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial
- Keywords
- exercise, peer support, behavior change
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial |
| Control Group | Active comparator | 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. Receives: Behavioral: The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 and 12 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start9 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Québécoise en Santé Respiratoire
- Responsible party
- Principal investigator, Shane Norman Sweet, McGill University
- Investigators
- Shane Sweet, Ph.D, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043428
- Sponsor's protocol ID
- 250965
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05043428
- Acronym / sponsor ID
- 250965
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- exercise, peer support, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Fondation Québécoise en Santé Respiratoire
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trialThose 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. |
| Control Group | Active comparator | Behavioral: The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trialThose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trialAn 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. | Behavioural | Control Group, Intervention Group |
Primary outcome
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.
10 secondary outcomes
Timed "Up & Go" test
Time frame: Baseline, 8 and 12 weeks
1-minute sit-to-stand test
Time frame: Baseline, 8 and 12 weeks
Handgrip Test
Time frame: Baseline, 8 and 12 weeks
Borg Scale - Dyspnea
Time frame: Baseline, 8 and 12 weeks
Godin Leisure Time Physical Activity Questionnaire
Time frame: Baseline, 8, and 12 weeks
The Psychological Need Satisfaction in Exercise scale
Time frame: Baseline, 8, and 12 weeks
The Treatment Self-Regulation Questionnaire
Time frame: Baseline, 8, and 12 weeks
Social Support from Peer Support Group Questionnaire
Time frame: 8 and 12 weeks
Medical Research Council Questionnaire on Breathlessness (mMRC)
Time frame: Baseline, 8, and 12 weeks
COPD Assessment Test (CAT)
Time frame: Baseline, 8, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shane Sweet, Ph.D principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pulmonary Disease, Chronic Obstructive, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in activities of daily and social living (time frame: Baseline, 8 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.