Pulmonary Disease, Chronic ObstructiveNCT04704310
Enhancing Exercise Training for Adults With COPD
A study testing Enhancing exercise training for adults with COPD: The roles of peers and functional tasks in people with Pulmonary Disease, Chronic Obstructive, run by McGill University at 1 site in Canada.
Trial summary
This study aims to find a new way to get individuals living with COPD to become and stay active during and after an exercise intervention. In this study, individuals living with COPD will participate in an online exercise intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Enhancing exercise training for adults with COPD: The roles of peers and functional tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2021to 15 Apr 2021
- 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
Inclusion Criteria: Individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a COPD diagnosis (any stage), 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, and speak English or French.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Exercise Training for Adults With COPD: The Roles of Peers and Functional Tasks
This study aims to find a new way to get individuals living with COPD to become and stay active during and after an exercise intervention. In this study, individuals living with COPD will participate in an online exercise intervention. The exercises included in this intervention are based in individuals' activities of daily living. Additionally, during this intervention, individuals with COPD will participate in peer support sessions and will be taught and encouraged to discuss eight 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 test out this new protocol and determine if it is feasible to recreate on a larger scale and if it is acceptable for the COPD community.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Enhancing exercise training for adults with COPD: The roles of peers and functional tasks
- 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.
Enhancing exercise training for adults with COPD: The roles of peers and functional tasksBehavioural
A proof-of-concept online 8-week exercise training program for adults with COPD that incorporates both a peer mentorship and a functional tasks component.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Individuals acting as own control. Looking at changes pre and post intervention Receives: Behavioral: Enhancing exercise training for adults with COPD: The roles of peers and functional tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Adherence
Intervention adherence will be measured be taking attendance for each session (2 x 8 weeks = 16 sessions). Intervention feasibility as an indicator of success will be an overall program adherence rate of 70% (approximately 11 sessions attended by all participants, respectively)
Measured: 8 weeks
Participant Engagement
Participant engagement will be measured by counting the number of unique topics brought up by each participant. The indicator of success will be that each participant initiates 1 topic of conversation in 70% of session (initiates 11 conversations during program)
Measured: 8 weeks
Goal Participation
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. 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: 8 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, immediately after intervention (9 weeks after baseline)
1-minute sit-to-stand test
This 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, keep their legs apart with about 90 degrees knee flexion and aligned with their hips, and are asked to hold their hands stationary on their hips.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, immediately after intervention (9 weeks after baseline)
Handgrip Test
A Hand Dynamometer was be used to measure handgrip strength. 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 recorded. The best of six measurements is used as an indication of upper body strength.
Measured: Baseline, immediately after intervention (9 weeks after baseline)
Six-minute walk test
To perform the six-minute walk test, participants walk along a track (or hallway) that is a minimum of 25 meters long (marked at each meter). Participants are instructed to walk at a comfortable pace for six minutes. Participants' dyspnea score will be measured using the modified Borg scale (Kendrick et al., 2000). A lower score, or covering less distance during the six minutes, is indicative of worse physical endurance and function (Sciurba et al., 2003). The distance walked by each participant during the six minutes is recorded after each test.
If participants do not have a hallway that is 25 meters long, participants are asked to run/walk as far as possible in 6 minutes, tracking the number of steps they take or distance travelled with a free application on their phone. Take pulse immediately after completing the exercise for 1 minute (determine bpm).
Measured: Baseline, immediately after intervention (9 weeks after baseline)
3-minute step test
An alternative for the 6-minute walk/run test that can be completed indoors. Participants' will step up onto a single step and then back down repeatedly for 3 minutes. To determine beats per minute (BPM), take pulse immediately after completing the exercise for 1 minute. Participants' dyspnea score will be measured using the modified Borg scale (Kendrick et al., 2000). Number of steps is also recorded (Beaumont et al., 2019). Results are relative to the individual but provides a good indication of aerobic fitness and can be used to track progress.
Measured: Baseline, immediately after intervention (9 weeks after baseline)
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, immediately after intervention (9 weeks after baseline)
Motivation for Exercise Questionnaire
This questionnaire was used to measure participants' reasons is for why they are, or would like to be, active on a regular basis. The rating scale is 1-7, 1 being not true at all, and 7 being very true
Measured: Baseline, immediately after intervention (9 weeks after baseline)
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, immediately after intervention (9 weeks after baseline)
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, immediately after intervention (9 weeks after baseline)
The Satisfaction with Life Questionnaire
This 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.
Measured: Baseline, immediately after intervention (9 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start27 Jan 2021
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
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
- Not applicable
- Intervention model
- Single group
- Model description
- A convenience sample of adults living with COPD (N=4-6) will be recruited to participate an 8- week online exercise intervention.The objective is to conduct a proof-of-concept online exercise intervention for individuals living with COPD, using functional tasks, and incorporating peer support.
- Masking
- None (open label)
- Enrolment
- 4 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 N Sweet, Ph.D, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704310
- Sponsor's protocol ID
- 250956
- Status last verified
- Aug 2021
- First submitted
- 22 Dec 2020
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exercise Training for Adults With COPD: The Roles of Peers and Functional Tasks
- ClinicalTrials.gov ID
- NCT04704310
- Acronym / sponsor ID
- 250956
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- exercise, peer support, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Fondation Québécoise en Santé Respiratoire
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 11 Jan 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 find a new way to get individuals living with COPD to become and stay active during and after an exercise intervention. In this study, individuals living with COPD will participate in an online exercise intervention. The exercises included in this intervention are based in individuals' activities of daily living. Additionally, during this intervention, individuals with COPD will participate in peer support sessions and will be taught and encouraged to discuss eight 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 test out this new protocol and determine if it is feasible to recreate on a larger scale and if it is acceptable for the COPD community.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A convenience sample of adults living with COPD (N=4-6) will be recruited to participate an 8- week online exercise intervention.The objective is to conduct a proof-of-concept online exercise intervention for individuals living with COPD, using functional tasks, and incorporating peer support.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Enhancing exercise training for adults with COPD: The roles of peers and functional tasksIndividuals acting as own control. Looking at changes pre and post intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Enhancing exercise training for adults with COPD: The roles of peers and functional tasksA proof-of-concept online 8-week exercise training program for adults with COPD that incorporates both a peer mentorship and a functional tasks component. | Behavioural | Intervention Group |
Primary outcome
Participant Adherence
Time frame: 8 weeks
Intervention adherence will be measured be taking attendance for each session (2 x 8 weeks = 16 sessions). Intervention feasibility as an indicator of success will be an overall program adherence rate of 70% (approximately 11 sessions attended by all participants, respectively)
Participant Engagement
Time frame: 8 weeks
Participant engagement will be measured by counting the number of unique topics brought up by each participant. The indicator of success will be that each participant initiates 1 topic of conversation in 70% of session (initiates 11 conversations during program)
Goal Participation
Time frame: 8 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. 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, immediately after intervention (9 weeks after baseline)
1-minute sit-to-stand test
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
Handgrip Test
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
Six-minute walk test
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
3-minute step test
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
Borg Scale - Dyspnea
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
Motivation for Exercise Questionnaire
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
Godin Leisure Time Physical Activity Questionnaire
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
The Psychological Need Satisfaction in Exercise scale
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
The Satisfaction with Life Questionnaire
Time frame: Baseline, immediately after intervention (9 weeks after baseline)
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 2 Sep 2021.
- 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 N 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 testing Enhancing exercise training for adults with COPD: The roles of peers and functional tasks in people with 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?
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 2 Sep 2021. 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?
Participant Adherence (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 2 Sep 2021.