COPDNCT04004585
A Sedentary Behaviour Reduction Intervention for People With COPD
A study testing Get Up For Your Health in people with COPD, run by West Park Healthcare Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Get Up For Your Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2019to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of co-existing conditions that may prevent participation in the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Get Up For Your Health: A Behaviour Change Intervention to Reduce Sedentary Behaviour 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.
- Conditions
- COPD
- Being tested
- Get Up For Your Health
- Keywords
- Sedentary behaviour, Behaviour change, Theoretical Domains Framework
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Get Up For Your HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Get Up For Your Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)
Measured: 4 weeks
Completion rate
Percentage of those enrolled who completed the program
Measured: 4 weeks
Participants satisfaction
Participant satisfaction will be assessed on a percentage scale of 0 to 100, with 100 being the best possible score.
Measured: 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
Measured: 4 weeks
Secondary outcomes (6)
Change in sedentary time
To assess the change in sedentary time as measured using an accelerometer from baseline to post-intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline - week 4 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start19 Jun 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Roger Goldstein, MD, Principal investigator, West Park Healthcare CentreDina Brooks, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004585
- Sponsor's protocol ID
- 19-012-WP
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34520411
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Up For Your Health: A Behaviour Change Intervention to Reduce Sedentary Behaviour for People With COPD
- ClinicalTrials.gov ID
- NCT04004585
- Acronym / sponsor ID
- 19-012-WP
- Conditions
- COPD
- Keywords
- Sedentary behaviour, Behaviour change, Theoretical Domains Framework
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Get Up For Your HealthThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of co-existing conditions that may prevent participation in the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Get Up For Your HealthThe 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. | Behavioural | Intervention |
Primary outcome
Enrollment rate
Time frame: 4 weeks
Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)
Completion rate
Time frame: 4 weeks
Percentage of those enrolled who completed the program
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.
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
6 secondary outcomes
Change in sedentary time
Time frame: Baseline - week 4 (post-intervention)
Change in number of sit-to-stand transitions
Time frame: Baseline - week 4 (post-intervention)
Change in daily number of steps
Time frame: Baseline - week 4 (post-intervention)
Change in self-efficacy
Time frame: Baseline - week 4 (post-intervention)
Change in outcome expectations
Time frame: Baseline - week 4 (post-intervention)
Change in knowledge of sedentary behaviour
Time frame: Baseline - week 4 (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 34520411Wshah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Goldstein, MD principal investigator
West Park Healthcare Centre
Dina Brooks, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get Up For Your Health in people with COPD, run by West Park Healthcare Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.