Feasibility of Dance in People With COPD
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|ClinicalTrials.gov Identifier: NCT03636594|
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
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|Condition or disease||Intervention/treatment||Phase|
|COPD||Other: Dance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"Let's Boogie": Feasibility of a Dance Intervention in Patients With Chronic Obstructive Pulmonary Disease|
|Actual Study Start Date :||January 30, 2017|
|Actual Primary Completion Date :||June 12, 2018|
|Actual Study Completion Date :||June 12, 2018|
This was a single arm study with all participants receiving the same intervention.
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.
- Enrollment rate [ Time Frame: 8 weeks ]Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)
- Attendance rate [ Time Frame: 8 weeks ]Attendance rate is calculated as a mean percentage for the group (number of sessions attended/ number of total sessions)
- 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.
- Occurrence of adverse events [ Time Frame: 8 weeks ]Adverse events were tracked and the program is considered safe and feasible if no adverse events occurred.
- 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.
- Change in Balance Evaluation Systems Test (BESTest) score [ Time Frame: Change from baseline to end of 8-week dance program ]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.
- Change in Berg Balance Scale score [ Time Frame: Change from baseline to end of 8-week dance program ]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.
- Change in balance confidence (activities specific balance scale) [ Time Frame: Change from baseline to end of 8-week dance program ]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.
- Change in anxiety and depression (hospital anxiety and depression scale) [ Time Frame: Change from baseline to end of 8-week dance program ]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
- Change in health related quality of life (chronic respiratory disease questionnaire) [ Time Frame: Change from baseline to end of 8-week dance program ]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
- Change in step count [ Time Frame: Change from baseline to end of 8-week dance program ]Measured using Fitbit charge2 physical activity trackers.
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Presence of comorbidities that could have prevented communication or safe exercise
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): NCT03636594
|West Park Healthcare Centre|
|Toronto, Ontario, Canada, M6M 2J5|
|Study Chair:||Dina Brooks, PhD||University of Toronto|
|Responsible Party:||Roger Goldstein, Clinical Professor, West Park Healthcare Centre|
|Other Study ID Numbers:||
|First Posted:||August 17, 2018 Key Record Dates|
|Last Update Posted:||August 17, 2018|
|Last Verified:||August 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Informed Consent Form (ICF)
|Time Frame:||Data will be available upon request and up to 7 years after publication|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|