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临床试验/NCT06986941
NCT06986941尚未招募不适用

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

Bezmialem Vakif University0 个研究点目标入组 24 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
Functional Capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Ballet-Based Dance Therapy (Behavioral)

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.

干预措施: Standard Care with Exercise Counseling (Other)

结局指标

主要结局

Functional Capacity

时间窗: 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 Vital Capacity (FVC)

时间窗: 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)

时间窗: 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 (%).

Forced Expiratory Volume in 1 Second (FEV₁)

时间窗: 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)

时间窗: 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%)

时间窗: 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).

次要结局

  • 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))
  • Balance(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))
  • Respiratory Muscle Strength(At baseline and at week 9 (after 8 weeks of intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selva Otsay

Principal Investigator

Bezmialem Vakif University

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