NCT04704310

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

January 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

December 22, 2020

Last Update Submit

August 27, 2021

Conditions

Keywords

exercisepeer supportbehavior change

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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.

    8 weeks

Secondary Outcomes (10)

  • Timed "Up & Go" test

    Baseline, immediately after intervention (9 weeks after baseline)

  • 1-minute sit-to-stand test

    Baseline, immediately after intervention (9 weeks after baseline)

  • Handgrip Test

    Baseline, immediately after intervention (9 weeks after baseline)

  • Six-minute walk test

    Baseline, immediately after intervention (9 weeks after baseline)

  • 3-minute step test

    Baseline, immediately after intervention (9 weeks after baseline)

  • +5 more secondary outcomes

Other Outcomes (2)

  • COPD Assessment Test (CAT)

    Baseline, immediately after intervention (9 weeks after baseline)

  • Medical Research Council Questionnaire on Breathlessness

    Baseline, immediately after intervention (9 weeks after baseline)

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Behavioral: Enhancing exercise training for adults with COPD: The roles of peers and functional tasks

Interventions

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.

Intervention Group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H2W 1S4, 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 N Sweet, Ph.D

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 22, 2020

First Posted

January 11, 2021

Study Start

January 27, 2021

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations