COPDNCT03636594
Feasibility of Dance in People With COPD
A study testing Dance in people with COPD, run by West Park Healthcare Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2017to 12 Jun 2018
- 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
- 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.
Who cannot join
- Presence of comorbidities that could have prevented communication or safe exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
- Conditions
- COPD
- Being tested
- Dance
- Keywords
- Dance, COPD, Maintenance program, Pulmonary rehabilitation
- 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.
DanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dance | Experimental | This was a single arm study with all participants receiving the same intervention. Receives: Other: Dance |
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: 8 weeks
Attendance rate
Attendance rate is calculated as a mean percentage for the group (number of sessions attended/ number of total sessions)
Measured: 8 weeks
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.
Measured: 8 weeks
Occurrence of adverse events
Adverse events were tracked and the program is considered safe and feasible if no adverse events occurred.
Measured: 8 weeks
Secondary outcomes (7)
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.
Measured: Change from baseline to end of 8-week dance program
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.
Measured: Change from baseline to end of 8-week dance program
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.
Measured: Change from baseline to end of 8-week dance program
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.
Measured: Change from baseline to end of 8-week dance program
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
Measured: Change from baseline to end of 8-week dance program
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
Measured: Change from baseline to end of 8-week dance program
Change in step count
Measured using Fitbit charge2 physical activity trackers.
Measured: Change from baseline to end of 8-week dance program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start30 Jan 2017
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- 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
- Collaborators
- Canadian Lung Association
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Dina Brooks, PhD, Study chair, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636594
- Sponsor's protocol ID
- 16-023-WP
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Let's Boogie": Feasibility of a Dance Intervention in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03636594
- Acronym / sponsor ID
- 16-023-WP
- Conditions
- COPD
- Keywords
- Dance, COPD, Maintenance program, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Collaborators
- Canadian Lung Association
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 17 Aug 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dance | Experimental | Other: DanceThis was a single arm study with all participants receiving the same intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of comorbidities that could have prevented communication or safe exercise
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 |
|---|---|---|
| DanceThe 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. | Other | Dance |
Primary outcome
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.
7 secondary outcomes
Change in functional capacity (6-minute walk test)
Time frame: Change from baseline to end of 8-week dance program
Change in Balance Evaluation Systems Test (BESTest) score
Time frame: Change from baseline to end of 8-week dance program
Change in Berg Balance Scale score
Time frame: Change from baseline to end of 8-week dance program
Change in balance confidence (activities specific balance scale)
Time frame: Change from baseline to end of 8-week dance program
Change in anxiety and depression (hospital anxiety and depression scale)
Time frame: Change from baseline to end of 8-week dance program
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 step count
Time frame: Change from baseline to end of 8-week dance program
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 17 Aug 2018.
- Individual participant dataSharing planned: Yes
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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.
Dina Brooks, PhD study chair
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance 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 4 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 17 Aug 2018. 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: 8 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?
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 17 Aug 2018.