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NCT Number: 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

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.

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Key information

Conditions

Parkinson's Disease (PD) Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ballet-Based Dance Therapy

Behavioral

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 Counseling

Other

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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 (%).

  5. 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).

  6. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doç. Dr. Semiramis Özyılmaz

CONTACT

[email protected]

+905337603610

Selva Otsay

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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