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临床试验/NCT07629063
NCT07629063已完成不适用

The Effects of Resistive Exercises Added to Aerobic and Balance Exercises on Quality of Life, Activities of Daily Living, Cognitive Functions, and Sarcopenia Parameters in Patients With Early-Stage Parkinson's Disease: A Prospective Randomized Controlled Study.

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1

研究概览

简要总结

The purpose of this study is to evaluate the effects of resistive exercises added to aerobic and balance exercises on quality of life, activities of daily living, cognitive functions, and sarcopenia parameters in patients diagnosed with early-stage PD. The main question it aims to answer is: In patients diagnosed with early-stage Parkinson's disease, do resistive exercises added to aerobic and balance exercises have an effect on quality of life, daily living activities, cognitive function, and sarcopenia parameters? If so, what is the nature of this effect? Patients will undergo an exercise program three days a week for eight weeks. Outcomes will be assessed at baseline, on the first day after the treatment and 4 weeks after the end of the treatment.

详细描述

Parkinson's disease (PD) is a neurodegenerative disease characterized by bradykinesia, rigidity, resting tremor and postural instability. It can lead to numerous motor, neuropsychiatric, cognitive, and autonomic symptoms. In advanced stages, it can increase the risk of falling by causing postural instability. Sarcopenia is characterized by a decrease in muscle mass and function. Sarcopenia prevalence increases with age, leading to increased fragility and risk of falling. Studies have shown that various exercise programs, including aerobic, balance, and resistive exercises, have positive effects on rigidity, tremor, gait disorders, and physical capacity in patients diagnosed with PD. The purpose of this study is to evaluate the effects of resistive exercises added to aerobic and balance exercises on quality of life, activities of daily living, cognitive functions, and sarcopenia parameters in patients diagnosed with early-stage PD.

Adults who aged between 40-70 years, diagnosed with PD and meet predefined inclusion and exclusion criteria will be enrolled and randomly assigned to one of two exercise based treatment groups. Both groups will receive aerobic and balance exercises, while one group will additionaly receive resistive exercises. Both groups will undergo exercise programs three days a week for eight weeks. Evaluations will be conducted using the The Parkinson's Disease Questionnaire-39 (PDQ-39), Short Physical Performance Battery (SPPB), SARC-F Questionnaire, Berg Balance Test, Katz Index of Independence in Activities of Daily Living, Montreal Cognitive Assesment (MoCA), Patient Health Questionnaire-9 (PH-9), functional performance tests, grip strentgh measurements and quadriceps muscle thickness measurement via ultrasonography. Evaluations will be performed at baseline, on the first day after the treatment and 4 weeks after the end of the treatment.

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 (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 40 to 70 years
  • Patients diagnosed with Modified Hoehn-Yahr stage 1-3 Parkinson's disease
  • Patients diagnosed with Parkinson's disease for more than 1 year
  • Patients who can mobilize without an assistive device

排除标准

  • Patients diagnosed with Parkinson Plus syndrome
  • History of uncontrolled hypertension
  • History of uncontrolled diabetes mellitus
  • History of serebrovascular disease within the past 6 months
  • History of miyocardial infarction within the past 6 months
  • History of knee or hip artroplasty surgery
  • History of severe cardiac arrythmia
  • Presence of cardiac pacemaker
  • Presence of severe dementia
  • History of severe psychiatric disorders
  • Patients who have on dialysis
  • Presence of acute infection
  • Pregnancy
  • History of malignancy

研究组 & 干预措施

Aerobic, Balance and Resistive Exercise Group

Experimental

Participants will receive an exercise program with 3 days a week for 8 weeks. Each treatment session will not exceed 45 minutes. Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate; balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance and resistive exercises for upper and lower extremity

干预措施: Exercise (Other)

Aerobic and Balance Exercise Group

Active Comparator

Participants will receive an exercise program with 3 days a week for 8 weeks. Each treatment session will not exceed 45 minutes. Program will include aerobic exercises with 15 minutes on a treadmill, aiming not to exceed 85% of maximum heart rate and balance exercises including tandem stance, tandem walk, side stepping, backward walking, single leg stance.

干预措施: Exercise (Other)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazlı İlgüner

Resident Physician

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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