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Not yet recruiting 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

No phase Interventional Parkinson's Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ballet-Based Dance Therapy, Standard Care with Exercise Counseling.
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Functional Capacity [Time frame: 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)]
  • Forced Vital Capacity (FVC) [Time frame: 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)]
  • Peak Expiratory Flow (PEF) [Time frame: 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)]
Secondary outcome measures (5)
  • Respiratory Muscle Strength [Time frame: 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)]
  • Cognitive Function [Time frame: 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)]
  • Change in Quality of Life [Time frame: At baseline and at week 9 (after 8 weeks of intervention)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 38233784
  • 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

Identifiers

NCT: NCT06986941 · SelvaPhD2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗