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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• Functional Capacity [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Forced Expiratory Volume in 1 Second (FEV₁) [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Forced Vital Capacity (FVC) [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Tiffeneau Index (FEV₁/FVC Ratio) [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Peak Expiratory Flow (PEF) [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Forced Expiratory Flow 25-75% (FEF₂₅-₇₅%) [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]

Вторичные конечные точки (5)

• Respiratory Muscle Strength [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Balance [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Cognitive Function [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Peripheral Muscle Strength [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]
• Change in Quality of Life [Срок оценки: At baseline and at week 9 (after 8 weeks of intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06986941 · SelvaPhD2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗