Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility of Dance in People With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03636594
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Canadian Lung Association
Information provided by (Responsible Party):
Roger Goldstein, West Park Healthcare Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Other: Dance Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Dance
This was a single arm study with all participants receiving the same intervention.
Other: Dance
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.




Primary Outcome Measures :
  1. Enrollment rate [ Time Frame: 8 weeks ]
    Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)

  2. 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)

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. Change in step count [ Time Frame: Change from baseline to end of 8-week dance program ]
    Measured using Fitbit charge2 physical activity trackers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Ontario
West Park Healthcare Centre
Toronto, Ontario, Canada, M6M 2J5
Sponsors and Collaborators
West Park Healthcare Centre
Canadian Lung Association
Investigators
Layout table for investigator information
Study Chair: Dina Brooks, PhD University of Toronto

Layout table for additonal information
Responsible Party: Roger Goldstein, Clinical Professor, West Park Healthcare Centre
ClinicalTrials.gov Identifier: NCT03636594     History of Changes
Other Study ID Numbers: 16-023-WP
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
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be available upon request and up to 7 years after publication

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roger Goldstein, West Park Healthcare Centre:
Dance
COPD
Maintenance program
Pulmonary rehabilitation

Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases