COPDNCT04039334
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)
A study testing Conventional Chest Physiotherapy and Creative Dance Based Exercise Training in people with COPD, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Conventional Chest Physiotherapy and Creative Dance Based Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having FEV1 / FVC <70% from pulmonary function test
- Being older than 18 years
- To be able to read and understand Turkish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation
Istanbul
About this study
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.
- Conditions
- COPD
- Being tested
- Conventional Chest Physiotherapy, Creative Dance Based Exercise Training
- Keywords
- COPD, Creative Dance, Exercise Training, 6 Minute Walk Test, Pulmonary Function Test, Postural Stability, Cognitive Functions, Muscle Strength
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Chest PhysiotherapyOther
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 TrainingOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Chest Physiotherapy; Other: Creative Dance Based Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Test
Change from baseline forced vital capacity (FVC) at 8 weeks.
Measured: Eight weeks
Respiratory Function Test
Change from baseline forced forced expiratory volume in 1 second at 8 weeks.
Measured: Eight weeks
Respiratory Function Test
Change from baseline peak expiratory flow (PEF) at 8 weeks.
Measured: Eight weeks
COPD Assessment Test (CAT)
Change from baseline CAT score at 8 weeks.
Measured: Eight weeks
BODE Index
Change from baseline BODE score at 8 weeks.
Measured: Eight weeks
Balance
Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.
Measured: Eight weeks
Balance
Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.
Measured: Eight weeks
Respiratory Muscle Strength
Change from baseline maximum inspiratory pressure at 8 weeks.
Measured: Eight weeks
Respiratory Function Test
Change from baseline maximum expiratory pressure at 8 weeks.
Measured: Eight weeks
Functional Capacity
Change from baseline distance covered in six minute walk test at 8 weeks.
Measured: Eight weeks
Change from baseline handgrip strength at 8 weeks.
Change from baseline m. quadriceps strength at 8 weeks.
Measured: Eight weeks
Change from baseline handgrip strength at 8 weeks.
Change from baseline m. biceps strength at 8 weeks.
Measured: Eight weeks
Change from baseline handgrip strength at 8 weeks.
Change from baseline handgrip strength at 8 weeks.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Sep 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Kaya, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039334
- Sponsor's protocol ID
- bvumkaya01
- Status last verified
- Feb 2021
- First submitted
- 26 Jul 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04039334
- Acronym / sponsor ID
- bvumkaya01
- Conditions
- COPD
- Keywords
- COPD, Creative Dance, Exercise Training, 6 Minute Walk Test, Pulmonary Function Test, Postural Stability, Cognitive Functions, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Chest PhysiotherapyPatients 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. |
| Training Group | Experimental | Other: Conventional Chest Physiotherapy, Other: Creative Dance Based Exercise TrainingIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having FEV1 / FVC <70% from pulmonary function test
- Being older than 18 years
- To be able to read and understand Turkish
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Chest PhysiotherapyConventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques. | Other | Control Group, Training Group |
| Creative Dance Based Exercise TrainingCreative 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. | Other | Training Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Chest Physiotherapy and Creative Dance Based Exercise Training in people with COPD, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Function Test (time frame: Eight weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.