Comparison of the Effects of Exercise by Functional Training, Stationary Bicycle and Exergame in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Proportion of recurrent fallers (2 or more falls over the study period)
研究概览
简要总结
Introduction: Population aging is associated with increased prevalence of chronic diseases. Parkinson's disease (PD) is the second most common neurodegenerative disease in the world population, affecting motor function and functional independence progressively. The physiological aging promotes the gradual reduction of body weight, lung function, peripheral muscle strength, cardiopulmonary endurance and physical capacity, which increase the debilitating effects. Aging, when associated with PD, can induce loss of functionality, postural changes, further affecting the nutritional status, worsening the quality of life and functional independence of the individual. Although physical therapy is commonly applied with a variety of methodologies to PD patients, evidence for the effectiveness of these interventions is lacking.
Objective: The primary objective of the study is to compare the effects of Functional Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly participants with PD. In addition, the secondary objectives are to compare the effects on cardiopulmonary endurance, posture, postural control, executive function, quality of life and functionality of individuals with PD.
Methodology: This is an interventional, randomized, blinded, longitudinal and prospective study. This research will be conducted in the State Reference Center for Health Care of the Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with undergo training with Stationary Bike and the Experimental Group 3 will be submitted to exergame training using Xbox360 with KinectTM sensor. All the interventions will be performed three times per week, with 50 minutes per session, during 8 weeks.
详细描述
The original study goal was to recruit 210 subjects based on the assumption of a fall risk of 70% in the Bicycle group and 40% in either Exergaming or Functional Training groups, with 80% power and alpha=0.05.
GROUPS:
G1-Functional Training
The intensity was increased by progressive resistance with dumbbells, ankle weights, elastic bands and manual resistance.
- Gait with obstacles: To perform this exercise hula hoops, rubber cones, plastic sticks, wood steps and mattresses were used.
- Up and down stairs and ramp: The participant went up and down 3 steps and 1 ramp until completing 3 minutes.
- Sitting and standing exercises: To increase the difficulty level were used manual resistance, dumbbell and unstable bases (swiss ball).
- Side gear and shin guards: The participant performed side gait according to the physical therapist's commands.
- Balance exercise: The participant performed balance exercises in proprioceptive platforms: balance discs, jumping beds proprioceptive tables.
- Activities with ball: Kicking balls of different sizes and weights, alternating each foot.
- Step exercises: Going up and down steps with the right or left foot according to cognitive commands of the physical therapist.
- Foot tip exercises: The participant performed the exercise on flat and sloped surface with one or two feet maintaining sural triceps contraction for 5 seconds.
- Graded reaching exercises: The exercise was performed standing and sitting. Dual task activities were performed.
- Gait training: The participant walked around the gym following verbal commands to stop and change direction. Gait reeducation consisted of working scapular and pelvic girdle dissociation.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Regular use of medication for PD;
- •Age greater than or equal to 60 years;
- •Stage 2, 2.5 or 3 according to the modified Hoehn and Yahr classification;
- •Signed informed consent.
排除标准
- •neurodegenerative diseases other than Parkinson disease; dementia; muscle diseases that preclude the practice of physical activity; chronic uncontrolled disease (hypertension, diabetes mellitus, chronic pain); unstable cardiovascular disease (acute heart failure, myocardial recent infarction, unstable angina and uncontrolled arrhythmia); using alcohol and other toxic substances; contraindications for performing exercise according the criteria of the American College of Sports Medicine; to practice or have practiced physical exercise program in the last six months; to participate or have participated in regular resistance training (eg, 2-3 times per week) in the previous 12 months.
结局指标
主要结局
Proportion of recurrent fallers (2 or more falls over the study period)
时间窗: 6 months after completion of the exercise training
次要结局
- Photometry-measured posture(8 weeks)
- Balance Evaluation Systems Test - BESTEST(8 weeks)
- Frontal Assessment Battery - FAB(8 weeks)
- World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0(8 weeks)
- 6-Minute Walk Test (cardiovascular endurance)(8 weeks)
- Number of falls(6 months)
- Get Up and Down Test(8 weeks)
- Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39(8 weeks)
- 10 meters test (gait speed)(8 weeks)
- Proportion of recurrent fallers (2 or more falls over the study period)(3 months)
研究者
Jamary Oliveira-Filho
Associate Professor
Federal University of Bahia