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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

Tracking Information
First Submitted Date  ICMJE July 26, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date March 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
  • Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline forced vital capacity (FVC) at 8 weeks.
  • Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline forced forced expiratory volume in 1 second at 8 weeks.
  • Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline peak expiratory flow (PEF) at 8 weeks.
  • COPD Assessment Test (CAT) [ Time Frame: Eight weeks ]
    Change from baseline CAT score at 8 weeks.
  • BODE Index [ Time Frame: Eight weeks ]
    Change from baseline BODE score at 8 weeks.
  • Balance [ Time Frame: Eight weeks ]
    Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.
  • Balance [ Time Frame: Eight weeks ]
    Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.
  • Respiratory Muscle Strength [ Time Frame: Eight weeks ]
    Change from baseline maximum inspiratory pressure at 8 weeks.
  • Respiratory Function Test [ Time Frame: Eight weeks ]
    Change from baseline maximum expiratory pressure at 8 weeks.
  • Functional Capacity [ Time Frame: Eight weeks ]
    Change from baseline distance covered in six minute walk test at 8 weeks.
  • Change from baseline handgrip strength at 8 weeks. [ Time Frame: Eight weeks ]
    Change from baseline m. quadriceps strength at 8 weeks.
  • Change from baseline handgrip strength at 8 weeks. [ Time Frame: Eight weeks ]
    Change from baseline m. biceps strength at 8 weeks.
  • Change from baseline handgrip strength at 8 weeks. [ Time Frame: Eight weeks ]
    Change from baseline handgrip strength at 8 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Conventional Chest Physiotherapy
  • 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.
    Interventions:
    • Other: Conventional Chest Physiotherapy
    • Other: Creative Dance Based Exercise Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2019)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 17, 2021
Estimated Primary Completion Date March 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Meltem Kaya, PT +902125232288 ext 4627 mramoglu@bezmialem.edu.tr
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039334
Other Study ID Numbers  ICMJE bvumkaya01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Meltem Kaya, Bezmialem Vakif University
Study Sponsor  ICMJE Bezmialem Vakif University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bezmialem Vakif University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP