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A Sedentary Behaviour Reduction Intervention for People With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004585
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre

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.

Condition or disease Intervention/treatment Phase
COPD Behavioral: Get Up For Your Health Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Get Up For Your Health: A Behaviour Change Intervention to Reduce Sedentary Behaviour for People With COPD
Actual Study Start Date : June 19, 2019
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Enrollment rate [ Time Frame: 4 weeks ]
    Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)

  2. Completion rate [ Time Frame: 4 weeks ]
    Percentage of those enrolled who completed the program

  3. Participants satisfaction [ Time Frame: 4 weeks ]
    Participant satisfaction will be assessed on a percentage scale of 0 to 100, with 100 being the best possible score.

  4. Adherence to wearing the activity monitor [ Time Frame: 4 weeks ]
    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


Secondary Outcome Measures :
  1. Change in sedentary time [ Time Frame: Baseline - week 4 (post-intervention) ]
    To assess the change in sedentary time as measured using an accelerometer from baseline to post-intervention.

  2. Change in number of sit-to-stand transitions [ Time Frame: Baseline - week 4 (post-intervention) ]
    To assess the change in the number of sit-to-stand transitions as measured using an accelerometer from baseline to post-intervention.

  3. Change in daily number of steps [ Time Frame: Baseline - week 4 (post-intervention) ]
    To assess the change in the number of steps as measured using an accelerometer from baseline to post-intervention.

  4. Change in self-efficacy [ Time Frame: Baseline - week 4 (post-intervention) ]
    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.

  5. Change in outcome expectations [ Time Frame: Baseline - week 4 (post-intervention) ]
    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.

  6. Change in knowledge of sedentary behaviour [ Time Frame: Baseline - week 4 (post-intervention) ]
    To assess the change in sedentary behaviour using an 8-item True or False questionnaire with higher scores indicating better knowledge of sedentary behaviour



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004585


Locations
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Canada, Ontario
West Park Healthcare Centre
Toronto, Ontario, Canada, M6M 2J5
Sponsors and Collaborators
West Park Healthcare Centre
Investigators
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Principal Investigator: Roger Goldstein, MD West Park Healthcare Centre
Principal Investigator: Dina Brooks, PhD McMaster University
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Responsible Party: Roger Goldstein, Clinical Professor, West Park Healthcare Centre
ClinicalTrials.gov Identifier: NCT04004585    
Other Study ID Numbers: 19-012-WP
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roger Goldstein, West Park Healthcare Centre:
Sedentary behaviour
Behaviour change
Theoretical Domains Framework