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)
Primary Purpose
COPD
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Chest Physiotherapy
Creative Dance Based Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Creative Dance, Exercise Training, 6 Minute Walk Test, Pulmonary Function Test, Postural Stability, Cognitive Functions, Muscle Strength
Eligibility Criteria
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
Sites / Locations
- Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Training Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Respiratory Function Test
Change from baseline forced vital capacity (FVC) at 8 weeks.
Respiratory Function Test
Change from baseline forced forced expiratory volume in 1 second at 8 weeks.
Respiratory Function Test
Change from baseline peak expiratory flow (PEF) at 8 weeks.
COPD Assessment Test (CAT)
Change from baseline CAT score at 8 weeks.
BODE Index
Change from baseline BODE score at 8 weeks.
Balance
Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.
Balance
Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.
Respiratory Muscle Strength
Change from baseline maximum inspiratory pressure at 8 weeks.
Respiratory Function Test
Change from baseline maximum expiratory pressure at 8 weeks.
Functional Capacity
Change from baseline distance covered in six minute walk test at 8 weeks.
Change from baseline handgrip strength at 8 weeks.
Change from baseline m. quadriceps strength at 8 weeks.
Change from baseline handgrip strength at 8 weeks.
Change from baseline m. biceps strength at 8 weeks.
Change from baseline handgrip strength at 8 weeks.
Change from baseline handgrip strength at 8 weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT04039334
First Posted
July 26, 2019
Last Updated
February 4, 2021
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04039334
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Creative Dance, Exercise Training, 6 Minute Walk Test, Pulmonary Function Test, Postural Stability, Cognitive Functions, Muscle Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Chest Physiotherapy
Intervention Description
Conventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques.
Intervention Type
Other
Intervention Name(s)
Creative Dance Based Exercise Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory Function Test
Description
Change from baseline forced vital capacity (FVC) at 8 weeks.
Time Frame
Eight weeks
Title
Respiratory Function Test
Description
Change from baseline forced forced expiratory volume in 1 second at 8 weeks.
Time Frame
Eight weeks
Title
Respiratory Function Test
Description
Change from baseline peak expiratory flow (PEF) at 8 weeks.
Time Frame
Eight weeks
Title
COPD Assessment Test (CAT)
Description
Change from baseline CAT score at 8 weeks.
Time Frame
Eight weeks
Title
BODE Index
Description
Change from baseline BODE score at 8 weeks.
Time Frame
Eight weeks
Title
Balance
Description
Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.
Time Frame
Eight weeks
Title
Balance
Description
Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.
Time Frame
Eight weeks
Title
Respiratory Muscle Strength
Description
Change from baseline maximum inspiratory pressure at 8 weeks.
Time Frame
Eight weeks
Title
Respiratory Function Test
Description
Change from baseline maximum expiratory pressure at 8 weeks.
Time Frame
Eight weeks
Title
Functional Capacity
Description
Change from baseline distance covered in six minute walk test at 8 weeks.
Time Frame
Eight weeks
Title
Change from baseline handgrip strength at 8 weeks.
Description
Change from baseline m. quadriceps strength at 8 weeks.
Time Frame
Eight weeks
Title
Change from baseline handgrip strength at 8 weeks.
Description
Change from baseline m. biceps strength at 8 weeks.
Time Frame
Eight weeks
Title
Change from baseline handgrip strength at 8 weeks.
Description
Change from baseline handgrip strength at 8 weeks.
Time Frame
Eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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)
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