A Sedentary Behaviour Reduction Intervention for People With COPD

Get Up For Your Health: A Behaviour Change Intervention to Reduce Sedentary Behaviour for People With COPD

Chronic obstructive pulmonary disease (COPD) is a major cause of disability. Individuals with COPD are more likely to spend prolonged periods of time in sedentary behaviour (SB) and less in light physical activity compared to their healthy peers. SB is associated with exercise intolerance, reduced motivation to exercise, lower self-efficacy and more frequent acute exacerbations among people with COPD. To date, there is very limited information regarding behavioural approaches to reduce SB in people with COPD. The aim of this study is to examine the feasibility of a new 4-week theory-informed behaviour change intervention to reduce SB in individuals with COPD.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: Get Up For Your Health

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6M 2J5
      • West Park Healthcare Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A diagnosis of COPD confirmed by spirometry Forced expired volume to forced vital capacity ration (FEV1/FVC) less than 0.7
• An ability to ambulate.
• An ability to provide informed consent.

Exclusion Criteria:

• Presence of co-existing conditions that may prevent participation in the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; This was a single arm study with all participants receiving the same intervention. Participants will receive a 4-week behaviour change intervention underpinned by the Theoretical Domains Framework (TDF) that aims to reduce sedentary behaviour.

Behavioral: Get Up For Your Health; The intervention is a 4-week behaviour change intervention underpinned by the Theoretical Domains Framework (TDF) that aims to reduce sedentary behaviour. The intervention consists of one individualized face-to-face session and 3 subsequent weekly points of contact (face-to-face meetings or phone calls). Behaviour change techniques will be provided including education, verbal persuasion, environmental restructuring and goal-setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)	4 weeks
Completion rate	Percentage of those enrolled who completed the program	4 weeks
Participants satisfaction	Participant satisfaction will be assessed on a percentage scale of 0 to 100, with 100 being the best possible score.	4 weeks
Adherence to wearing the activity monitor	Percentage of those who were able to provide data for at least 8 hours per day of wearing time during waking hours and for at least 4 days/week for the entire duration of the study	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sedentary time	To assess the change in sedentary time as measured using an accelerometer from baseline to post-intervention.	Baseline - week 4 (post-intervention)
Change in number of sit-to-stand transitions	To assess the change in the number of sit-to-stand transitions as measured using an accelerometer from baseline to post-intervention.	Baseline - week 4 (post-intervention)
Change in daily number of steps	To assess the change in the number of steps as measured using an accelerometer from baseline to post-intervention.	Baseline - week 4 (post-intervention)
Change in self-efficacy	To assess the change in self-efficacy to sit less using a scale adapted from the Multidimensional Self-Efficacy Scale over time from baseline to post-intervention. The scale consists of 9 items that measures 3 components of self-efficacy (task, coping and scheduling) with each item is measured on a scale of 0 (no confidence at all) up to 100 (complete confidence). The total score is the average of the scores of the 9 items.	Baseline - week 4 (post-intervention)
Change in outcome expectations	To assess the change in the outcome expectations using a 15-item scale adapted from the Multidimensional Outcome Expectations for Exercise Scale over time from baseline to post-intervention. The questionnaire is a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree), that assesses physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items) with the higher the scores the more positive the outcome expectations are. The total score is the sum of the score of the 15 items.	Baseline - week 4 (post-intervention)
Change in knowledge of sedentary behaviour	To assess the change in sedentary behaviour using an 8-item True or False questionnaire with higher scores indicating better knowledge of sedentary behaviour	Baseline - week 4 (post-intervention)

Collaborators and Investigators

• Sponsor: West Park Healthcare Centre
• Investigators: Principal Investigator: Dina Brooks, PhD, McMaster University; Principal Investigator: Roger Goldstein, MD, West Park Healthcare Centre

Publications and helpful links

General Publications

• Wshah A, Selzler AM, Hill K, Brooks D, Goldstein R. Embedding a Behavior Change Program Designed to Reduce Sedentary Time Within a Pulmonary Rehabilitation Program Is Feasible in People With COPD. J Cardiopulm Rehabil Prev. 2022 Jan 1;42(1):45-51. doi: 10.1097/HCR.0000000000000624.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: June 30, 2019
• First Submitted That Met QC Criteria: June 30, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Behaviour change; Sedentary behaviour; Theoretical Domains Framework
• Other Study ID Numbers: 19-012-WP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No