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

Not Applicable

Not yet recruiting

• Conditions: Parkinson's Disease (PD)

• Registration Number: NCT06986941
• Lead Sponsor: Bezmialem Vakif University

Brief 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. 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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-04
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity (FVC)	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)	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 (%).
Functional Capacity	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)	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).
Peak Expiratory Flow (PEF)	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%)	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).

Secondary Outcome Measures

Name	Time	Method
Balance	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.
Cognitive Function	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.
Peripheral Muscle Strength	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.
Change in Quality of Life	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.
Respiratory Muscle Strength	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.