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Enhancing Exercise Training for Adults With COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Enhancing exercise training for adults with COPD: The roles of peers and functional tasks
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 (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.

Sites / Locations

  • McGill University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Individuals acting as own control. Looking at changes pre and post intervention

Outcomes

Primary Outcome Measures

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)
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)
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.

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

Full Information

First Posted
December 22, 2020
Last Updated
August 27, 2021
Sponsor
McGill University
Collaborators
Fondation Québécoise en Santé Respiratoire
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1. Study Identification

Unique Protocol Identification Number
NCT04704310
Brief Title
Enhancing Exercise Training for Adults With COPD
Official Title
Enhancing Exercise Training for Adults With COPD: The Roles of Peers and Functional Tasks
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (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 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.

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
Single Group Assignment
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)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Individuals acting as own control. Looking at changes pre and post intervention
Intervention Type
Behavioral
Intervention Name(s)
Enhancing exercise training for adults with COPD: The roles of peers and functional tasks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant Adherence
Description
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)
Time Frame
8 weeks
Title
Participant Engagement
Description
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)
Time Frame
8 weeks
Title
Goal Participation
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. 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
8 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, immediately after intervention (9 weeks after baseline)
Title
1-minute sit-to-stand test
Description
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.
Time Frame
Baseline, immediately after intervention (9 weeks after baseline)
Title
Handgrip Test
Description
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.
Time Frame
Baseline, immediately after intervention (9 weeks after baseline)
Title
Six-minute walk test
Description
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).
Time Frame
Baseline, immediately after intervention (9 weeks after baseline)
Title
3-minute step test
Description
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.
Time Frame
Baseline, immediately after intervention (9 weeks after baseline)
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, immediately after intervention (9 weeks after baseline)
Title
Motivation for Exercise Questionnaire
Description
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
Time Frame
Baseline, immediately after intervention (9 weeks after baseline)
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, immediately after intervention (9 weeks after baseline)
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, immediately after intervention (9 weeks after baseline)
Title
The Satisfaction with Life Questionnaire
Description
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.
Time Frame
Baseline, immediately after intervention (9 weeks after baseline)
Other Pre-specified Outcome Measures:
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. Items include: I never cough| I cough all the time, I have no phlegm (mucus) in my chest at all | My chest is completely full of phlegm (mucus), My chest does not feel tight at all | My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless | When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home| I am very limited doing activities at home, I am confident leaving my home despite my lung condition| I am not at all confident leaving my home because of my lung condition, I sleep soundly | I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.
Time Frame
Baseline, immediately after intervention (9 weeks after baseline)
Title
Medical Research Council Questionnaire on Breathlessness
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, immediately after intervention (9 weeks after baseline)

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 (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shane N 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
H2W 1S4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Exercise Training for Adults With COPD

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