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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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ClinicalTrials.gov Identifier: NCT04039334
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Meltem Kaya, Bezmialem Vakif University

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.


Condition or disease Intervention/treatment Phase
COPD Other: Conventional Chest Physiotherapy Other: Creative Dance Based Exercise Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 17, 2021
Estimated Study Completion Date : May 17, 2021

Resource links provided by the National Library of Medicine


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.
Other: Conventional Chest Physiotherapy
Conventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques.

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.
Other: Conventional Chest Physiotherapy
Conventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques.

Other: Creative Dance Based Exercise Training
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 Measures :
  1. Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline forced vital capacity (FVC) at 8 weeks.

  2. Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline forced forced expiratory volume in 1 second at 8 weeks.

  3. Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline peak expiratory flow (PEF) at 8 weeks.

  4. COPD Assessment Test (CAT) [ Time Frame: Eight weeks ]
    Change from baseline CAT score at 8 weeks.

  5. BODE Index [ Time Frame: Eight weeks ]
    Change from baseline BODE score at 8 weeks.

  6. Balance [ Time Frame: Eight weeks ]
    Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.

  7. Balance [ Time Frame: Eight weeks ]
    Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.

  8. Respiratory Muscle Strength [ Time Frame: Eight weeks ]
    Change from baseline maximum inspiratory pressure at 8 weeks.

  9. Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline maximum expiratory pressure at 8 weeks.

  10. Functional Capacity [ Time Frame: Eight weeks ]
    Change from baseline distance covered in six minute walk test at 8 weeks.

  11. Change from baseline handgrip strength at 8 weeks. [ Time Frame: Eight weeks ]
    Change from baseline m. quadriceps strength at 8 weeks.

  12. Change from baseline handgrip strength at 8 weeks. [ Time Frame: Eight weeks ]
    Change from baseline m. biceps strength at 8 weeks.

  13. Change from baseline handgrip strength at 8 weeks. [ Time Frame: Eight weeks ]
    Change from baseline handgrip strength at 8 weeks.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04039334


Contacts
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Contact: Meltem Kaya, PT +902125232288 ext 4627 mramoglu@bezmialem.edu.tr

Locations
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Turkey
Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation Recruiting
Istanbul, Turkey
Sponsors and Collaborators
Bezmialem Vakif University
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Responsible Party: Meltem Kaya, Research Asistant, PT, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04039334    
Other Study ID Numbers: bvumkaya01
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meltem Kaya, Bezmialem Vakif University:
COPD
Creative Dance
Exercise Training
6 Minute Walk Test
Pulmonary Function Test
Postural Stability
Cognitive Functions
Muscle Strength
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases