NCT04039334

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

July 26, 2019

Last Update Submit

February 4, 2021

Conditions

Keywords

COPDCreative DanceExercise Training6 Minute Walk TestPulmonary Function TestPostural StabilityCognitive FunctionsMuscle Strength

Outcome Measures

Primary Outcomes (13)

  • Respiratory Function Test

    Change from baseline forced vital capacity (FVC) at 8 weeks.

    Eight weeks

  • Respiratory Function Test

    Change from baseline forced forced expiratory volume in 1 second at 8 weeks.

    Eight weeks

  • Respiratory Function Test

    Change from baseline peak expiratory flow (PEF) at 8 weeks.

    Eight weeks

  • COPD Assessment Test (CAT)

    Change from baseline CAT score at 8 weeks.

    Eight weeks

  • BODE Index

    Change from baseline BODE score at 8 weeks.

    Eight weeks

  • Balance

    Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.

    Eight weeks

  • Balance

    Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.

    Eight weeks

  • Respiratory Muscle Strength

    Change from baseline maximum inspiratory pressure at 8 weeks.

    Eight weeks

  • Respiratory Function Test

    Change from baseline maximum expiratory pressure at 8 weeks.

    Eight weeks

  • Functional Capacity

    Change from baseline distance covered in six minute walk test at 8 weeks.

    Eight weeks

  • Change from baseline handgrip strength at 8 weeks.

    Change from baseline m. quadriceps strength at 8 weeks.

    Eight weeks

  • Change from baseline handgrip strength at 8 weeks.

    Change from baseline m. biceps strength at 8 weeks.

    Eight weeks

  • Change from baseline handgrip strength at 8 weeks.

    Change from baseline handgrip strength at 8 weeks.

    Eight weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Training Group

EXPERIMENTAL

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 PhysiotherapyOther: Creative Dance Based Exercise Training

Interventions

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

Control GroupTraining Group

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.

Training Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having FEV1 / FVC \<70% from pulmonary function test
  • Being older than 18 years
  • To be able to read and understand Turkish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation

Istanbul, Turkey (Türkiye)

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant, PT

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 31, 2019

Study Start

September 1, 2019

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Locations