A Sedentary Behaviour Reduction Intervention for People With COPD

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Behavioral: Get Up For Your Health


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedentary behaviour, Behaviour change, Theoretical Domains Framework