The Effect of Resistance Training on Balance in Patients With Parkinson Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Postural sway on Static Posturography
研究概览
简要总结
To investigate if resistance training exercises performed twice a week with or without gym equipment assistance in a 12-week period could improve balance in patients with Parkinson Disease (PD).
Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and preserved cognitive function will participate in this study. Patients will be randomized among three intervention groups: resistance training with free weights, resistance training with gym equipment and control group. Investigators will use static platform balance variables to assess the primary end-point outcome measures. For the secondary outcomes measures, most common clinical functional balances tests for PD will be applied: Berg Balance Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and variables from dynamic posturography.
详细描述
Parkinson's disease is a progressive neurodegenerative disease that affects motor functions and is characterized by bradykinesia, resting tremor, rigidity, and postural instability. Despite of pharmacological treatments, patients remain with deficits in balance, gait, autonomic system functions and cognition which impact on their quality of life.
The effects of resistance training on PD are still controversial when balance and improvement on functional tests are the targets.
Since the results of previous studies about resistance training on balance are still controversial, more interventions are required to address the question if strengthening exercise may improve or not the balance of PD patients. Our exercises will target the trunk, leg and shoulder muscles because of their contribution on patient's posture.
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 (Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 to 75 years old;
- •Hoehn and Yahr stages II or III;
- •Idiopathic Parkinson disease diagnosed according to the United Kingdom Parkinson's Disease Society Brain Research Centre Criteria, Institute of Neurology, London;
- •Ability to walk independently without walking devices aid;
- •Absence of orthopedic injuries or pain in joints that could interfere on training program;
- •Stable medication regimen for PD treatment at recruitment stage;
- •Mini Mental State Examination Scale (MMSE) ≥ to 27 for literate patients and schooling ≥ of 4 years of formal education;
- •No cardiovascular instability;
- •No pacemaker, decompensated metabolic disease, vestibular dysfunction, and stroke;
- •Availability to come to the clinic twice a week;
- •Not participating in other physical rehabilitation programs during and six months prior to the study.
排除标准
- •Patients will be excluded if they refuse to participate, do not sign the consent form, have a diagnosis of secondary parkinsonism or present cognitive impairment.
研究组 & 干预措施
Gym Group
With gym equipments, twice per week for 12 weeks.
干预措施: Gym Group (Other)
Free Weights Group
With dumbbells, elastics, twice per week for 12 weeks.
干预措施: Free Weights Group (Other)
Control Group
The control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet.
干预措施: Control Group (Other)
结局指标
主要结局
Postural sway on Static Posturography
时间窗: 12 weeks
Static Posturography is a technique used to objectively assess postural sway with patients standing still on a fixed platform that measures center of pressure displacement. Tests were standardized such as the feet position, the eye gaze and environment light, with three trials of 60-second test in eyes - open, eyes closed and eyes open in dual task condition. Investigators will analyze the anteroposterior displacement, medial-lateral displacement, area, velocity and path length.
次要结局
- Balance on Berg Balance Scale(12 weeks)
- Balance Evaluation on Mini-BESTest(12 weeks)
- Functional balance and gait on Timed Up and Go test (TUG)(12 weeks)
- Quality of life on PDQ-39 Questionnaire(12 weeks)
- Functional balance on Dynamic Posturography(12 weeks)