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Completed

NCT Number: NCT04004585

A Sedentary Behaviour Reduction Intervention 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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

West Park Healthcare Centre

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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