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

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: Not yet recruiting
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Behavioral: Ballet-Based Dance Therapy; Other: Standard Care with Exercise Counseling

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: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doç. Dr. Semiramis Özyılmaz; Phone Number: +905337603610; Email: SOzyilmaz@bezmialem.edu.tr
• Study Contact Backup: Name: Selva Otsay; Email: selvaotsay99@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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 (%).	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).	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).	At baseline and at week 9 (after 8 weeks of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	At baseline and at week 9 (after 8 weeks of intervention)

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Publications and helpful links

General 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.
• McGill 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 4, 2025
• First Submitted That Met QC Criteria: May 22, 2025
• First Posted (Actual): May 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Quality of Life; Cognitive Function; Respiratory Function; Ballet-based Dance Therapy
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID 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