A Sedentary Behaviour Reduction Intervention for People With COPD

NCT04004585 | Completed

• 1 other identifier: 19-012-WP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

Sedentary behaviour; Behaviour change; Theoretical Domains Framework

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change in sedentary time

  Baseline - week 4 (post-intervention)

• Change in number of sit-to-stand transitions

  Baseline - week 4 (post-intervention)

• Change in daily number of steps

  Baseline - week 4 (post-intervention)

• Change in self-efficacy

  Baseline - week 4 (post-intervention)

• Change in outcome expectations

  Baseline - week 4 (post-intervention)

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Get Up For Your Health BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

• 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.

  PMID: 34520411 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roger Goldstein, MD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

• Dina Brooks, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 30, 2019
• First Posted: July 2, 2019
• Study Start: June 19, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)