NCT03636594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

August 2, 2018

Last Update Submit

August 15, 2018

Conditions

Keywords

DanceCOPDMaintenance programPulmonary rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Enrollment rate

    Enrollment rate is calculated as a percentage (number of people enrolled/ number of people approached)

    8 weeks

  • Attendance rate

    Attendance rate is calculated as a mean percentage for the group (number of sessions attended/ number of total sessions)

    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.

    8 weeks

  • Occurrence of adverse events

    Adverse events were tracked and the program is considered safe and feasible if no adverse events occurred.

    8 weeks

Secondary Outcomes (7)

  • Change in functional capacity (6-minute walk test)

    Change from baseline to end of 8-week dance program

  • Change in Balance Evaluation Systems Test (BESTest) score

    Change from baseline to end of 8-week dance program

  • Change in Berg Balance Scale score

    Change from baseline to end of 8-week dance program

  • Change in balance confidence (activities specific balance scale)

    Change from baseline to end of 8-week dance program

  • Change in anxiety and depression (hospital anxiety and depression scale)

    Change from baseline to end of 8-week dance program

  • +2 more secondary outcomes

Study Arms (1)

Dance

EXPERIMENTAL

This was a single arm study with all participants receiving the same intervention.

Other: Dance

Interventions

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.

Dance

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of comorbidities that could have prevented communication or safe exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dina Brooks, PhD

    University of Toronto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 17, 2018

Study Start

January 30, 2017

Primary Completion

June 12, 2018

Study Completion

June 12, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available upon request and up to 7 years after publication

Locations