- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039334
The Effects of Creative Dance Based Exercise Training on Respiratory, Balance and Cognitive Functions, Respiratory and Peripheral Muscle Strength and Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
COPD is a common, preventable and treatable disease associated with an increased chronic inflammatory response of the airways and lungs to harmful gases and particles and characterized by progressive airflow restriction, which is usually progressive. Exercise intolerance is one of the most important outcomes of COPD. Dyspnea and leg fatigue are the main symptoms that limit exercise and patients restrict their activity to avoid these disturbing conditions. Exercise training is the most appropriate method for improving exercise tolerance and muscle function. It is considered and recommended by ERS and ATS as an essential component of PR. Endurance training is considered to be one of the most important components of the PR program. Walking, running, cycling, stair climbing, dancing are examples of endurance exercises. Dance-based exercise training; It is an entertaining method that increases physical, functional, cognitive, emotional and social integration. This alternative method has frequently been tried in the literature in the treatment of Parkinson's, cancer and psychiatric diseases and its effects on functional capacity, balance, and quality of life have been demonstrated. The importance of our research; This is the first study to apply dance based exercise training in chronic respiratory diseases.
The aim of this study was to investigate the effect of creative dance based exercise training on respiratory, balance and cognitive functions, respiratory and peripheral muscle strength and functional capacity in COPD patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having FEV1 / FVC <70% from pulmonary function test
- Being older than 18 years
- To be able to read and understand Turkish
Exclusion Criteria:
- No exacerbation in 8 weeks.
- Attending current or regular exercise training in the last 1 year
- Having diagnosed vision, hearing, vestibular or neurological problems that may affect balance
- Having orthopedic, musculoskeletal or cardiovascular comorbid conditions that may affect ambulation
- Being on long-term oxygen therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control Group
Patients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 week.
All exercise sessions will be performed at home.
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Conventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques.
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EXPERIMENTAL: Training Group
In addition to conventional chest physiotherapy programme, patients in this group will also receive creative dance based exercise training for 60 minutes, 2 times in a week for 8 weeks.
All exercise sessions will be supervised in a clinic per week.
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Conventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques.
Creative dance based exercise training will be given under the supervision of a physiotherapist who takes creative dance instructor training 2 days and 60 minutes per week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Function Test
Time Frame: Eight weeks
|
Change from baseline forced vital capacity (FVC) at 8 weeks.
|
Eight weeks
|
Respiratory Function Test
Time Frame: Eight weeks
|
Change from baseline forced forced expiratory volume in 1 second at 8 weeks.
|
Eight weeks
|
Respiratory Function Test
Time Frame: Eight weeks
|
Change from baseline peak expiratory flow (PEF) at 8 weeks.
|
Eight weeks
|
COPD Assessment Test (CAT)
Time Frame: Eight weeks
|
Change from baseline CAT score at 8 weeks.
|
Eight weeks
|
BODE Index
Time Frame: Eight weeks
|
Change from baseline BODE score at 8 weeks.
|
Eight weeks
|
Balance
Time Frame: Eight weeks
|
Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.
|
Eight weeks
|
Balance
Time Frame: Eight weeks
|
Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.
|
Eight weeks
|
Respiratory Muscle Strength
Time Frame: Eight weeks
|
Change from baseline maximum inspiratory pressure at 8 weeks.
|
Eight weeks
|
Respiratory Function Test
Time Frame: Eight weeks
|
Change from baseline maximum expiratory pressure at 8 weeks.
|
Eight weeks
|
Functional Capacity
Time Frame: Eight weeks
|
Change from baseline distance covered in six minute walk test at 8 weeks.
|
Eight weeks
|
Change from baseline handgrip strength at 8 weeks.
Time Frame: Eight weeks
|
Change from baseline m. quadriceps strength at 8 weeks.
|
Eight weeks
|
Change from baseline handgrip strength at 8 weeks.
Time Frame: Eight weeks
|
Change from baseline m. biceps strength at 8 weeks.
|
Eight weeks
|
Change from baseline handgrip strength at 8 weeks.
Time Frame: Eight weeks
|
Change from baseline handgrip strength at 8 weeks.
|
Eight weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- bvumkaya01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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