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

NCT06986941 | Not Yet Recruiting

• 1 other identifier: SelvaPhD2025-001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease (PD)

Keywords

Ballet-based Dance Therapy; Respiratory Function; Balance; Cognitive Function; Quality of Life

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Respiratory Muscle Strength

  At baseline and at week 9 (after 8 weeks of intervention)

• Balance

  At baseline and at week 9 (after 8 weeks of intervention)

• Cognitive Function

  At baseline and at week 9 (after 8 weeks of intervention)

• Peripheral Muscle Strength

  At baseline and at week 9 (after 8 weeks of intervention)

• Change in Quality of Life

  At baseline and at week 9 (after 8 weeks of intervention)

Study Arms (2)

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.

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.

Other: Standard Care with Exercise Counseling

Interventions

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.

Ballet-Based Dance Therapy

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.

Standard Care with Exercise Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Related Publications (2)

• 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.

  PMID: 38233784 BACKGROUND

• 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.

  PMID: 31038440 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Doç. Dr. Semiramis Özyılmaz

CONTACT

+905337603610; SOzyilmaz@bezmialem.edu.tr

Selva Otsay

CONTACT

selvaotsay99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 23, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share