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临床试验/NCT07302386
NCT07302386尚未招募不适用

The Effects of Exercise Management in Parkinson's Disease

Marmara University0 个研究点目标入组 30 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Change in motor impairment

研究概览

简要总结

The aim of this study is to examine the benefits that individuals with Parkinson's disease will gain from the rehabilitation program by enabling them to manage their exercise times independently using telerehabilitation method.

The main research questions examined in this study are as follows:

  • Are the improvements in quality of life, walking speed and changes in functionality parameters achieved by individuals with Parkinson's disease through managing their own exercise plans as effective as those achieved through a supervised exercise programme?
  • Is it effective for Parkinson's patients to manage their own exercise plans in improving their adherence to exercise?

详细描述

Parkinson's Disease (PD) is a movement disorder characterized by motor and non-motor symptoms, changes in the patient's balance and gait patterns, and a significant impact on daily living activities. Physical therapy and rehabilitation play a crucial role in managing the symptoms resulting from PD. It is known that early participation in a rehabilitation program significantly improves patients' quality of life.

Patients need to incorporate exercise prescriptions designed specifically for them into their lives and participate in a lifelong exercise program. While integrating these exercises into their lives, patients encounter certain barriers and lose their motivation to exercise. These barriers can include transportation, economic problems, time management, and motor and non-motor symptoms.

Home-based exercises and telerehabilitation methods emerge as solutions for dealing with transportation, economic problems, and time management. These methods can be seen as important aids in helping patients develop the habit of exercising.

Patients diagnosed with Idiopathic Parkinson's Disease who meet the inclusion criteria and agree to participate in the study will be included. The demographic information (age, occupation, height, body weight, etc.) and clinical status (duration of diagnosis, medication dosage, etc.) of all participants will be recorded. The Montreal Cognitive Assessment Scale will be used to determine the cognitive level of patients. The motor assessment of patients will be performed using the Cognitive Parkinson's Disease Assessment Scale III. The Montreal Cognitive Assessment Scale will be used to determine the cognitive level of patients. Functional balance and mobility will be assessed using the Timed Up and Go Test and the 10-meter Walk Test. Repetitive movement performance will be assessed using the 5 Repeat Sit-to-Stand Test, and balance level will be assessed using the Activity-Specific Balance Confidence Scale. Quality of life will be assessed using the Parkinson's Disease Quality of Life Questionnaire. Motivation to exercise and self-assessment will be determined using the Behavioral Modifications to Exercise Scale-2. These assessment criteria will be re-evaluated before and after the exercise program. Patients will be given an exercise diary and asked to keep it throughout the program. The System Usability Scale will be used to evaluate the usability of the website developed for this thesis study.

Participants will be randomly assigned to 2 groups. The control group will complete the exercise program assigned to them continuously via the web-based system. The experimental group will complete the exercise program assigned to them at their preferred time within the same day. Exercise programs will be planned for 8 weeks.

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
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Idiopathic Parkinson's Disease by a neurologist according to the UK Parkinson's Disease Association Brain Bank clinical diagnostic criteria
  • H&Y Stage I-III
  • Montreal Cognitive Assessment Scale MoCA≥21
  • Having the necessary technological devices to participate in telerehabilitation
  • Being able to walk 100 meters
  • Having at least a primary school diploma

排除标准

  • Presence of a neurological disorder other than Parkinson's disease
  • Presence of any cardiopulmonary or musculoskeletal problem that affects gait and balance
  • Receiving Deep Brain Stimulation (DBS) treatment or having undergone DBS surgery in the past
  • Presence of vision or hearing problems

结局指标

主要结局

Change in motor impairment

时间窗: Baseline and the end of the 8 weeks exercise program

The Unified Parkinson's Disease Rating Scale (UPDRS) is used to determine the symptoms and clinical severity of PD. The UPDRS-III subscore will be used to assess changes in motor impairment.

Change in behavioral regulations in exercise

时间窗: Baseline and the end of the 8 weeks exercise program

Behavioral Regulations in Exercise Questionnaire-2 consists of 19 items and five subscales. The subscales consist of external regulation, internalized regulation, defined regulation, internal regulation and lack of motivation. It is a 5-point Likert-type scale scored between 0-4.

Change in lower extremity power and endurance

时间窗: Baseline and the end of the 8 weeks exercise program

Five Times Sit to Stand Test will be used to measure repetitive movement performance. The patient will be asked to sit down and stand up 5 times as quickly as possible, and this time will be recorded in seconds.

Change in walking speed

时间窗: Baseline and the end of the 8 weeks exercise program

10-Meter Walk Test will be applied to assess walking speed. The first 2 meters of the 14-meter distance are allocated for acceleration, the last 2 meters for deceleration, and the time taken to walk the 10-meter distance is recorded. Walking speed is calculated in meters per second.

Change in mobility

时间窗: Baseline and the end of the 8 weeks exercise program

Timed Up and Go Test is used to assess mobility, balance, and risk of falling. The patient is asked to stand up from a chair, walk around a cone 3 meters away, and return to sit on the chair. The total time is recorded using a stopwatch.

Change in body position

时间窗: Baseline and the end of the 8 weeks exercise program

Activities-Specific Balance Confidence is a measure that assesses a person's level of confidence in their balance both indoors and outdoors. It consists of 16 different activities and is rated on a scale from no confidence (-0) to complete confidence (-100). A higher score indicates a greater level of confidence in balance.

Change in quality of life

时间窗: Baseline and the end of the 8 weeks exercise program

The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) will be used to assess quality of life. It consists of 39 items and is composed of 8 sub-parameters: mobility, activities of daily living, stigma, social support, communication, emotional well-being, and physical discomfort. As the score increases, quality of life deteriorates.

次要结局

未报告次要终点

研究者

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

Gökçe Kartal

MSc, PT

Marmara University

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