Clinical trial NCT05043428: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: exercise
peer support
behavior change
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Fondation Québécoise en Santé Respiratoire
First posted: 2021-09-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Performance in activities of daily and social living
timeFrame: Baseline, 8 and 12 weeks
Secondary outcomes:
measure: Timed "Up & Go" test
timeFrame: Baseline, 8 and 12 weeks
measure: 1-minute sit-to-stand test
timeFrame: Baseline, 8 and 12 weeks
measure: Handgrip Test
timeFrame: Baseline, 8 and 12 weeks
measure: Borg Scale - Dyspnea
timeFrame: Baseline, 8 and 12 weeks
measure: Godin Leisure Time Physical Activity Questionnaire
timeFrame: Baseline, 8, and 12 weeks
measure: The Psychological Need Satisfaction in Exercise scale
timeFrame: Baseline, 8, and 12 weeks
measure: The Treatment Self-Regulation Questionnaire
timeFrame: Baseline, 8, and 12 weeks
measure: Social Support from Peer Support Group Questionnaire
timeFrame: 8 and 12 weeks
measure: Medical Research Council Questionnaire on Breathlessness (mMRC)
timeFrame: Baseline, 8, and 12 weeks
measure: COPD Assessment Test (CAT)
timeFrame: Baseline, 8, and 12 weeks
Other outcomes:
measure: Activities, Healthcare, and Research Priorities Survey
timeFrame: Baseline, 8, and 12 weeks
measure: Three Factor Social Identity Questionnaire
timeFrame: 8, and 12 weeks
measure: The Acceptability of Intervention Measure (AIM)
timeFrame: 8, and 12 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 8, and 12 weeks
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 8, and 12 weeks
measure: 6-Item Health Care Climate Questionnaire
timeFrame: 4, 8, and 12 weeks
measure: Behaviour Change Technique Usage Questionnaire
timeFrame: baseline, 8, and 12 weeks
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Shane Sweet, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: