NCT05043428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

September 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

August 27, 2021

Last Update Submit

February 7, 2022

Conditions

Keywords

exercisepeer supportbehavior change

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 8 and 12 weeks

Secondary Outcomes (10)

  • Timed "Up & Go" test

    Baseline, 8 and 12 weeks

  • 1-minute sit-to-stand test

    Baseline, 8 and 12 weeks

  • Handgrip Test

    Baseline, 8 and 12 weeks

  • Borg Scale - Dyspnea

    Baseline, 8 and 12 weeks

  • Godin Leisure Time Physical Activity Questionnaire

    Baseline, 8, and 12 weeks

  • +5 more secondary outcomes

Other Outcomes (7)

  • Activities, Healthcare, and Research Priorities Survey

    Baseline, 8, and 12 weeks

  • Three Factor Social Identity Questionnaire

    8, and 12 weeks

  • The Acceptability of Intervention Measure (AIM)

    8, and 12 weeks

  • +4 more other outcomes

Study Arms (2)

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.

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.

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

Interventions

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.

Control GroupIntervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A 0G4, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Shane Sweet, Ph.D

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 14, 2021

Study Start

September 9, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations