A Sedentary Behaviour Reduction Intervention for People With COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004585
• Other study ID #: 19-012-WP
• Status: Completed
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: December 18, 2019

Study information

• Verified date: June 2020
• Source: West Park Healthcare Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
Canada	West Park Healthcare Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)	4 weeks
Primary	Completion rate	Percentage of those enrolled who completed the program	4 weeks
Primary	Participants satisfaction	Participant satisfaction will be assessed on a percentage scale of 0 to 100, with 100 being the best possible score.	4 weeks
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)