COPD Clinical Trial
Official title:
"Let's Boogie": Feasibility of a Dance Intervention in Patients With Chronic Obstructive Pulmonary Disease
| Verified date | August 2018 |
| Source | West Park Healthcare Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | June 12, 2018 |
| Est. primary completion date | June 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | West Park Healthcare Centre | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| West Park Healthcare Centre | Canadian Lung Association |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Enrollment rate | Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached) | 8 weeks | |
| Primary | Attendance rate | Attendance rate is calculated as a mean percentage for the group (number of sessions attended/ number of total sessions) | 8 weeks | |
| Primary | Participant satisfaction and perceived benefits (Participant satisfaction questionnaire) questionnaire | 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. | 8 weeks | |
| Primary | Occurrence of adverse events | Adverse events were tracked and the program is considered safe and feasible if no adverse events occurred. | 8 weeks | |
| Secondary | Change in functional capacity (6-minute walk test) | 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 from baseline to end of 8-week dance program | |
| Secondary | Change in Balance Evaluation Systems Test (BESTest) score | 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 from baseline to end of 8-week dance program | |
| Secondary | Change in Berg Balance Scale score | 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 from baseline to end of 8-week dance program | |
| Secondary | Change in balance confidence (activities specific balance scale) | 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 from baseline to end of 8-week dance program | |
| Secondary | Change in anxiety and depression (hospital anxiety and depression scale) | 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 from baseline to end of 8-week dance program | |
| Secondary | Change in health related quality of life (chronic respiratory disease questionnaire) | 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 from baseline to end of 8-week dance program | |
| Secondary | Change in step count | Measured using Fitbit charge2 physical activity trackers. | Change from baseline to end of 8-week dance program |
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