- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03636594
Feasibility of Dance in People With COPD
August 15, 2018 updated by: Roger Goldstein, West Park Healthcare Centre
"Let's Boogie": Feasibility of a Dance Intervention in Patients With Chronic Obstructive Pulmonary Disease
Despite the benefits associated with individuals with chronic obstructive pulmonary disease (COPD) engaging in pulmonary rehabilitation (PR) programs, the benefits diminish by 6 months.
A new innovative approach is needed to increase motivation to exercise and to minimize diminution of effect.
Dance is a fun and interactive activity, which has shown benefits in other populations, such as Parkinson's disease and stroke.
The aim of this study was to investigate the feasibility of dance in individuals with COPD following PR.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M6M 2J5
- West Park Healthcare Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of COPD confirmed by spirometry (FEV1/FVC < 0.7)
- Adequate communication with or without corrective hearing aids
- No intensive PR for at least 6 months before recruitment
- An ability to provide informed consent.
Exclusion Criteria:
- Presence of comorbidities that could have prevented communication or safe exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dance
This was a single arm study with all participants receiving the same intervention.
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The dance program consisted of one-hour dance classes delivered twice a week for 8 weeks.
The classes featured different dance types (such as partnered and non-partnered) and genres (such as salsa, ballroom and jazz) with increasing complexity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enrollment rate
Time Frame: 8 weeks
|
Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)
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8 weeks
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Attendance rate
Time Frame: 8 weeks
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Attendance rate is calculated as a mean percentage for the group (number of sessions attended/ number of total sessions)
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8 weeks
|
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Participant satisfaction and perceived benefits (Participant satisfaction questionnaire) questionnaire
Time Frame: 8 weeks
|
Participant satisfaction and the perceived benefits were assessed by asking participants to complete a nine-item survey which asked participants to report their level of agreement with statements on enjoyment and perceived improvements or benefits according to a 5-point Likert type scale (1 = strongly agree, 5 = strongly disagree).
The questionnaire contained open-ended questions asking participants what they liked best and least as well as what they would change about the intervention.
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8 weeks
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Occurrence of adverse events
Time Frame: 8 weeks
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Adverse events were tracked and the program is considered safe and feasible if no adverse events occurred.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in functional capacity (6-minute walk test)
Time Frame: Change from baseline to end of 8-week dance program
|
Changes in the distance walked as measured using 6-minute walk test.
The farther the distance walked in 6 minutes, the better the functional capacity.
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Change from baseline to end of 8-week dance program
|
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Change in Balance Evaluation Systems Test (BESTest) score
Time Frame: Change from baseline to end of 8-week dance program
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Change in balance from baseline to end of 8-week dance program as measured by Balance Evaluation Systems Test (BESTest).
The BESTest consists of 36 items that evaluate balance impairments across six postural control contexts.
These six contexts are: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation and stability in gait.
Total score of BESTest is 108 points (the item-level score ranges from 0 "severe impairment to 3 "no impairment"), calculated into a percentage score (0%-100%) with the higher score the better the balance.
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Change from baseline to end of 8-week dance program
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Change in Berg Balance Scale score
Time Frame: Change from baseline to end of 8-week dance program
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Change in balance from baseline to end of 8-week dance program as measured by Balance Evaluation Systems Test (BESTest) and Berg balance scale.
Berg balance scale comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot.
The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores, with a higher score indicating better balance.
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Change from baseline to end of 8-week dance program
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Change in balance confidence (activities specific balance scale)
Time Frame: Change from baseline to end of 8-week dance program
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Change in balance confidence from baseline to end of 8-week dance program as measured using the Activities-specific Balance Confidence (ABC) scale.
The scale consists of 16 statements on different activities and the participant indicates their level of confidence in doing the activities without losing their balance or becoming unsteady from choosing one of the percentage points on the scale from 0% to 100% with the higher values represent a better balance confidence.
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Change from baseline to end of 8-week dance program
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Change in anxiety and depression (hospital anxiety and depression scale)
Time Frame: Change from baseline to end of 8-week dance program
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Change in anxiety and depression from baseline to end of 8-week dance program measured using Hospital Anxiety and Depression Scale.The scale consisted of 14 items (seven for anxiety and the same for depression).
Each item is a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression with the lower score is the better outcome
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Change from baseline to end of 8-week dance program
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Change in health related quality of life (chronic respiratory disease questionnaire)
Time Frame: Change from baseline to end of 8-week dance program
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Change in health related quality of life from baseline to end of 8-week dance program measured using the chronic respiratory questionnaire which is an interviewer-administered one that measures both physical and emotional aspects of chronic respiratory disease.
The questionnaire is a 7-point modified Likert Scale, consists of 20 items that explore four categories: dyspnea, fatigue, emotional function and mastery.
The maximum score possible is 140 and the lowest is 20 with the higher scores indicate better health-related quality of life
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Change from baseline to end of 8-week dance program
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Change in step count
Time Frame: Change from baseline to end of 8-week dance program
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Measured using Fitbit charge2 physical activity trackers.
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Change from baseline to end of 8-week dance program
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Dina Brooks, PhD, University of Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2017
Primary Completion (Actual)
June 12, 2018
Study Completion (Actual)
June 12, 2018
Study Registration Dates
First Submitted
August 2, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 15, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 16-023-WP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Time Frame
Data will be available upon request and up to 7 years after publication
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.