Comparison of the Effects of Resistance and Aerobic Exercises Added to Conventional Rehabilitation Program on Walking and Sarcopenic Parameters in Patients With Sarcopenic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Handgrip Strength
研究概览
简要总结
The aim of this study was to investigate the effects of resistance and aerobic exercises on the following outcomes in patients with sarcopenic Parkinson's disease: Timed Up and Go Test (TUG), gait speed, Short Physical Performance Battery (SPPB), handgrip strength, Five-Times Sit-to-Stand Test, and MDS-UPDRS Part II scores.
详细描述
Female and male patients aged between 40 and 85 years, who meet the inclusion criteria, will be recruited from the Outpatient Clinic of Physical Medicine and Rehabilitation (PMR), Ahi Evran University Kırşehir Training and Research Hospital. A total of 30 participants will be enrolled in the study.
This is a prospective, randomized, controlled trial. Assessments will be performed at baseline (week 0), at the end of treatment (week 6), and at follow-up (week 12). Outcome measures will include:
Handgrip strength Timed Up and Go Test (TUG) 4-meter gait speed test Short Physical Performance Battery (SPPB) Five-Times Sit-to-Stand Test (5CST) MDS-UPDRS Part II questionnaire
In addition, at baseline, ultrasonographic measurement of anterior thigh muscle thickness will be performed. This value, expressed in millimeters, will be divided by the body mass index (BMI) to calculate the STAR (Sonographic Thigh Adjustment Ratio) index.Participants will be randomized into three treatment groups:
Group 3 (Conventional Rehabilitation Program):
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 40-85 years with a clinical diagnosis of Parkinson's disease.
- •Diagnosis of sarcopenia according to the EWGSOP2 criteria.
- •Hoehn & Yahr stage 2-
- •Ability and willingness to provide written informed consent according to the approved study consent form.
排除标准
- •Failure to meet diagnostic criteria for sarcopenia.
- •Hoehn & Yahr stage 1 or
- •History of malignancy.
- •Epilepsy.
- •History of cardiac pacemaker implantation.
- •Presence of congestive heart failure.
- •Orthopedic conditions affecting walking or balance.
- •Respiratory disorders impairing exercise capacity.
- •Uncontrolled hypertension.
- •Inability to cooperate with study procedures.
- •History of neuromuscular or vestibular disorders affecting gait or balance parameters.
- •Lack of willingness to participate in the study.
研究组 & 干预措施
Conventional rehabilitation + Aerobic exercise
Participants will receive a standard conventional rehabilitation program combined with supervised aerobic exercise training (e.g., treadmill ) according to guideline-based frequency, intensity, and duration.
干预措施: Aerobic Exercise (Behavioral)
Conventional rehabilitation + Aerobic exercise
Participants will receive a standard conventional rehabilitation program combined with supervised aerobic exercise training (e.g., treadmill ) according to guideline-based frequency, intensity, and duration.
干预措施: Conventional Rehabilitation (Behavioral)
Conventional rehabilitation + Resistance exercises
Participants will receive a standard conventional rehabilitation program combined with supervised resistance exercise training targeting major muscle groups with free weights or elastic bands.
干预措施: Resistance Exercise (Behavioral)
Conventional rehabilitation + Resistance exercises
Participants will receive a standard conventional rehabilitation program combined with supervised resistance exercise training targeting major muscle groups with free weights or elastic bands.
干预措施: Conventional Rehabilitation (Behavioral)
Conventional rehabilitation
Participants will receive only the standard conventional rehabilitation program without any additional aerobic or resistance exercise.
干预措施: Conventional Rehabilitation (Behavioral)
结局指标
主要结局
Handgrip Strength
时间窗: BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)
Maximal isometric handgrip strength of the dominant hand measured with a handheld dynamometer. Higher values indicate better strength
Five Times Chair Stand Test
时间窗: BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)
Time (in seconds) to rise from a chair and sit back down five consecutive times without using arms. Lower values indicate better performance. Unit of Measure: seconds
Timed Up and Go Test (TUG Test)
时间窗: BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)
The Timed Up and Go (TUG) test measures mobility by timing a participant rising from a chair, walking 3 m, turning, and sitting down. Lower values indicate better performance. Unit of Measure: seconds
4-Meter Walking Speed
时间窗: BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)
Usual-pace walking speed over a 4-meter course, recorded as distance divided by time. Higher values indicate better performance. Unit of Measure: meters/second
Short Physical Performance Battery (SPPB) Score
时间窗: BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12)
Composite score including balance tests, 4-meter gait speed, and repeated chair stands; range 0 (worst) to 12 (best). Higher scores indicate better performance. Unit of Measure: score (0-12)
次要结局
- MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living(BEFORE TREATMENT(WEEK 0),AT THE END OF TREATMENT (WEEK 6) AND AFTER TREATMENT (WEEK 12))
研究者
Nedime Seven Tas
Principal Investigator
Ahi Evran University Education and Research Hospital