Parkinson's Disease (PD)NCT06986941
The Effects of Ballet-Based Exercise Training on Respiratory Functions, Balance, Cognitive Functions, Peripheral Muscle Strength, Functional Capacity and Quality of Life in Patients With Parkinson's Disease
A study testing Ballet-Based Dance Therapy in people with Parkinson's Disease (PD), run by Bezmialem Vakif University.
Trial summary
This study investigates the impact of an 8-week ballet-based dance therapy on people with Parkinson's disease. It aims to assess the effect of ballet on motor and non-motor symptoms, such as balance, cognitive function, functional capacity, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Ballet-Based Dance Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- Diagnosed with Parkinson's disease.
- Modified Hoehn and Yahr stages I to III.
- Willingness to participate and provide informed consent.
Who cannot join
- Joint deformities or severe movement limitations that prevent participation in dance exercises.
- Mental retardation (severe cognitive impairment).
- Major surgery within the past 6 months.
- Presence of uncontrolled cardiovascular, pulmonary, or oncological diseases.
- Diagnosed visual or auditory impairments affecting balance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Selva Otsay contact
About this study
This study investigates the impact of an 8-week ballet-based dance therapy on people with Parkinson's disease. It aims to assess the effect of ballet on motor and non-motor symptoms, such as balance, cognitive function, functional capacity, and quality of life. The study will provide insights into the potential of ballet therapy as an effective, non-pharmacological treatment for Parkinson's disease.
Read the detailed description
This clinical trial aims to evaluate the effects of an 8-week ballet-based dance therapy on individuals with Parkinson's disease. The intervention will target motor and non-motor symptoms, including functional capacity, balance, cognitive function, and quality of life. Participants will be randomly assigned to either the intervention group or a control group. The intervention group will engage in structured ballet classes, while the control group will receive standard care. Assessments will include measures of respiratory function, body composition, muscle strength, and balance, with evaluations conducted before and after the intervention. The goal is to assess the feasibility and effectiveness of ballet as a therapeutic approach to improve both physical and mental well-being in people with Parkinson's disease.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Ballet-Based Dance Therapy, Standard Care with Exercise Counseling
- Keywords
- Ballet-based Dance Therapy, Respiratory Function, Balance, Cognitive Function, Quality of Life
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballet-Based Dance TherapyBehavioural
An 8-week ballet-based dance therapy program designed to improve balance, flexibility, peripheral muscle strength, cognitive functions, and overall functional capacity in Parkinson's disease patients. The therapy will be conducted twice a week, with each session lasting approximately 60 minutes. The exercises will be adapted to the participants' physical abilities and will focus on enhancing motor coordination, strength, and stability through ballet-inspired movements.
Standard Care with Exercise CounselingOther
Participants in the control group will receive standard care for Parkinson's disease, including pharmacological management and routine clinical follow-up. Additionally, they will receive a one-time exercise counseling session and an informational brochure outlining general home-based exercises appropriate for individuals with Parkinson's disease. No supervised or structured exercise sessions will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Ballet-Based Dance Therapy | Experimental | Participants in this arm will engage in an 8-week ballet-based dance therapy program, specifically designed to enhance functional capacity, balance, peripheral muscle strength, cognitive function, and overall quality of life. The program will be conducted twice a week, with each session lasting approximately 60 minutes. The dance exercises will be tailored to meet the needs of individuals with Parkinson's disease, focusing on improving motor skills, flexibility, and coordination. The primary goal is to assess the impact of ballet-based exercises on various parameters such as respiratory function, balance, and muscle strength. Receives: Behavioral: Ballet-Based Dance Therapy |
| Standard Care with Exercise Counseling | Active comparator | Participants in this arm will continue with their standard medical treatment for Parkinson's disease, including pharmacological management and routine care. Additionally, they will receive a one-time exercise counseling session delivered by a physiotherapist and an informational brochure that includes recommendations for general, unsupervised home-based exercises suitable for Parkinson's patients. No structured or supervised exercise sessions will be provided. Receives: Other: Standard Care with Exercise Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Functional capacity will be assessed using the Six-Minute Walk Test (6MWT) according to American Thoracic Society (ATS) guidelines. The total distance walked will be recorded.
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Forced Expiratory Volume in 1 Second (FEV₁)
FEV₁ will be assessed using spirometry and reported in liters (L). FEV1 will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Forced Vital Capacity (FVC)
FVC will be assessed using spirometry and reported in liters (L). FVC will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Tiffeneau Index (FEV₁/FVC Ratio)
The ratio of FEV₁ to FVC will be calculated using spirometry and reported as a percentage (%).
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Peak Expiratory Flow (PEF)
PEF will be assessed using spirometry and reported in liters per minute (L/min). PEF will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%)
FEF₂₅-₇₅% will be assessed using spirometry and reported in liters per second (L/s). FEF₂₅-₇₅%will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Secondary outcomes (5)
Respiratory Muscle Strength
Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a digital mouth pressure device, in accordance with established respiratory assessment guidelines.
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Balance
Balance performance will be assessed using the Biodex Balance System. Stability indices will be calculated to evaluate postural control and balance.
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Cognitive Function
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point scale ranging from 0 to 30, where higher scores indicate better cognitive performance.
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Peripheral Muscle Strength
Peripheral muscle strength will be assessed using a hand-held dynamometer for major lower extremity muscle groups.
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Change in Quality of Life
Quality of life will be assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The total score ranges from 0 to 100, with higher scores indicating worse quality of life.
Measured: At baseline and at week 9 (after 8 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (PD)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selva Otsay, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986941
- Sponsor's protocol ID
- SelvaPhD2025-001
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Podlewska AM, Batzu L, Soukup T, Sevdalis N, Bakolis I, Derbyshire-Fox F, Hartley A, Healey A, Woods A, Crane N, Pariante C, Ray Chaudhuri K. The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson's disease. BMC Complement Med Ther. 2024 Jan 17;24(1):41. doi: 10.1186/s12906-023-04296-y.
PubMed 38233784McGill A, Houston S, Lee RYW. Effects of a ballet-based dance intervention on gait variability and balance confidence of people with Parkinson's. Arts Health. 2019 Jun;11(2):133-146. doi: 10.1080/17533015.2018.1443947. Epub 2018 Mar 6.
PubMed 31038440
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ballet-Based Exercise Training on Respiratory Functions, Balance, Cognitive Functions, Peripheral Muscle Strength, Functional Capacity and Quality of Life in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06986941
- Acronym / sponsor ID
- SelvaPhD2025-001
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Ballet-based Dance Therapy, Respiratory Function, Balance, Cognitive Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 May 2025 (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.
This study investigates the impact of an 8-week ballet-based dance therapy on people with Parkinson's disease. It aims to assess the effect of ballet on motor and non-motor symptoms, such as balance, cognitive function, functional capacity, and quality of life. The study will provide insights into the potential of ballet therapy as an effective, non-pharmacological treatment for Parkinson's disease.
Detailed description
This clinical trial aims to evaluate the effects of an 8-week ballet-based dance therapy on individuals with Parkinson's disease. The intervention will target motor and non-motor symptoms, including functional capacity, balance, cognitive function, and quality of life. Participants will be randomly assigned to either the intervention group or a control group. The intervention group will engage in structured ballet classes, while the control group will receive standard care. Assessments will include measures of respiratory function, body composition, muscle strength, and balance, with evaluations conducted before and after the intervention. The goal is to assess the feasibility and effectiveness of ballet as a therapeutic approach to improve both physical and mental well-being in people with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ballet-Based Dance Therapy | Experimental | Behavioral: Ballet-Based Dance TherapyParticipants in this arm will engage in an 8-week ballet-based dance therapy program, specifically designed to enhance functional capacity, balance, peripheral muscle strength, cognitive function, and overall quality of life. The program will be conducted twice a week, with each session lasting approximately 60 minutes. The dance exercises will be tailored to meet the needs of individuals with Parkinson's disease, focusing on improving motor skills, flexibility, and coordination. The primary goal is to assess the impact of ballet-based exercises on various parameters such as respiratory function, balance, and muscle strength. |
| Standard Care with Exercise Counseling | Active comparator | Other: Standard Care with Exercise CounselingParticipants in this arm will continue with their standard medical treatment for Parkinson's disease, including pharmacological management and routine care. Additionally, they will receive a one-time exercise counseling session delivered by a physiotherapist and an informational brochure that includes recommendations for general, unsupervised home-based exercises suitable for Parkinson's patients. No structured or supervised exercise sessions will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Diagnosed with Parkinson's disease.
- Modified Hoehn and Yahr stages I to III.
- Willingness to participate and provide informed consent.
Key exclusion criteria (5 listed)
- Joint deformities or severe movement limitations that prevent participation in dance exercises.
- Mental retardation (severe cognitive impairment).
- Major surgery within the past 6 months.
- Presence of uncontrolled cardiovascular, pulmonary, or oncological diseases.
- Diagnosed visual or auditory impairments affecting balance.
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 |
|---|---|---|
| Ballet-Based Dance TherapyAn 8-week ballet-based dance therapy program designed to improve balance, flexibility, peripheral muscle strength, cognitive functions, and overall functional capacity in Parkinson's disease patients. The therapy will be conducted twice a week, with each session lasting approximately 60 minutes. The exercises will be adapted to the participants' physical abilities and will focus on enhancing motor coordination, strength, and stability through ballet-inspired movements. | Behavioural | Ballet-Based Dance Therapy |
| Standard Care with Exercise CounselingParticipants in the control group will receive standard care for Parkinson's disease, including pharmacological management and routine clinical follow-up. Additionally, they will receive a one-time exercise counseling session and an informational brochure outlining general home-based exercises appropriate for individuals with Parkinson's disease. No supervised or structured exercise sessions will be conducted. | Other | Standard Care with Exercise Counseling |
Primary outcome
Functional Capacity
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
Functional capacity will be assessed using the Six-Minute Walk Test (6MWT) according to American Thoracic Society (ATS) guidelines. The total distance walked will be recorded.
Forced Expiratory Volume in 1 Second (FEV₁)
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
FEV₁ will be assessed using spirometry and reported in liters (L). FEV1 will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Forced Vital Capacity (FVC)
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
FVC will be assessed using spirometry and reported in liters (L). FVC will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Tiffeneau Index (FEV₁/FVC Ratio)
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
The ratio of FEV₁ to FVC will be calculated using spirometry and reported as a percentage (%).
Peak Expiratory Flow (PEF)
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
PEF will be assessed using spirometry and reported in liters per minute (L/min). PEF will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%)
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
FEF₂₅-₇₅% will be assessed using spirometry and reported in liters per second (L/s). FEF₂₅-₇₅%will be measured according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
5 secondary outcomes
Respiratory Muscle Strength
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
Balance
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
Cognitive Function
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
Peripheral Muscle Strength
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
Change in Quality of Life
Time frame: At baseline and at week 9 (after 8 weeks of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 38233784Podlewska AM, Batzu L, Soukup T, Sevdalis N, Bakolis I, Derbyshire-Fox F, Hartley A, Healey A, Woods A, Crane N, Pariante C, Ray Chaudhuri K. The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson's disease. BMC Complement Med Ther. 2024 Jan 17;24(1):41. doi: 10.1186/s12906-023-04296-y.
- Background: PubMed 31038440McGill A, Houston S, Lee RYW. Effects of a ballet-based dance intervention on gait variability and balance confidence of people with Parkinson's. Arts Health. 2019 Jun;11(2):133-146. doi: 10.1080/17533015.2018.1443947. Epub 2018 Mar 6.
- Individual participant dataSharing planned: No
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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.
Selva Otsay contact
Questions about this trial
What is this clinical trial studying?
A study testing Ballet-Based Dance Therapy in people with Parkinson's Disease (PD), run by Bezmialem Vakif University.
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 4 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: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doç. Dr. Semiramis Özyılmaz (+905337603610, SOzyilmaz@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: At baseline and at week 9 (after 8 weeks of intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06986941, which also lists 2 linked publications.
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 23 May 2025.