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

May 22, 2025 updated by: Selva Otsay, Bezmialem Vakif University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ballet-Based Dance Therapy
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.
Behavioral: Ballet-Based Dance Therapy
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.
Active Comparator: Standard Care with Exercise Counseling
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.
Other: Standard Care with Exercise Counseling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and at week 9 (after 8 weeks of intervention)
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).
At baseline and at week 9 (after 8 weeks of intervention)
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).
At baseline and at week 9 (after 8 weeks of intervention)
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 (%).
At baseline and at week 9 (after 8 weeks of intervention)
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).
At baseline and at week 9 (after 8 weeks of intervention)
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).
At baseline and at week 9 (after 8 weeks of intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory Muscle Strength
Time Frame: At baseline and at week 9 (after 8 weeks of intervention)
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.
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)
Balance performance will be assessed using the Biodex Balance System. Stability indices will be calculated to evaluate postural control and balance.
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)
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.
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)
Peripheral muscle strength will be assessed using a hand-held dynamometer for major lower extremity muscle groups.
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)
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.
At baseline and at week 9 (after 8 weeks of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SelvaPhD2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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