The Effects of the Hopeful Outdoor Parkinson Exercise (HOPE) Program on Improving Balance, Gait and Functional Performance in Parkinsonian Non-fallers and Single Fallers - a Randomized Controlled Trial With 12-month Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Changes from baseline Balance Systems Evaluation Test total and subsection scores at post 4-week training, post 8-week training, 6- and 12-month follow-ups
研究概览
简要总结
To determine whether the 8-week Hopeful Outdoor Parkinson's Exercise (HOPE) Program would be effective in improving balance performance, physical functions, gait parameter, balance confidence, health-related quality-of-life, disease-specific motor performance and fall-related outcomes in Parkinson's disease (PD) non-fallers and single fallers.
详细描述
Previous studies demonstrated that multi-modal balance training program was effective in improving balance performance in people with PD. However they did not include all the balance domains and outdoor fall-prone activities have been overlooked. We designed a task- and context-specific balance training program based on the framework of the Balance Evaluation Systems Test (BESTest) to target all six balance domains including biomechanical constraints, stability limits and verticality, anticipatory postural adjustments, reactive postural responses, sensori-motor integration and dynamic gait control.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with PD by a neurologist (Fahn and Elton, 1987);
- •aged 30 to 85 years;
- •at modified Hoehn and Yahr (H&Y) stage 1.5 to 3 (Hoehn and Yahr ,1967; Goetz et al., 2004);
- •able and willing to give written consent for participation in the study;
- •living at home in the community;
- •able to walk independently for 30 metres with or without an assistive device.
排除标准
- •any neurological conditions other than PD;
- •significant musculoskeletal or cardiopulmonary diseases;
- •other disorders that may affect balance or locomotion;
- •taken any structured behavioral or exercise programs in the past 3 months
- •or they are receiving regular physical rehabilitation at present;
- •unstable condition on anti-parkinsonian medications;
- •surgical interventions for PD;
- •communication or cognitive deficits with mini-mental state examination, (MMSE) <24/30 (Folstein et al., 1975);
- •a history of more than two falls in the previous 12 months.
研究组 & 干预措施
EXPERIMENTAL
a 4-week indoor and 4-week outdoor balance training with stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice
干预措施: an 8-week blended indoor-outdoor exercise program (Behavioral)
CONTROL
an eight-week training on upper limb stretching and strengthening, hand agility exercise, knot tying and Chinese calligraphy
干预措施: an 8-week upper limb and hand exercise program (Behavioral)
结局指标
主要结局
Changes from baseline Balance Systems Evaluation Test total and subsection scores at post 4-week training, post 8-week training, 6- and 12-month follow-ups
时间窗: 12 months after intervention
次要结局
- Changes from baseline Parkinson's disease Questionnaire (PDQ-39) at post 4-week training, post 8-week training, 6- and 12-month follow-ups(12 months after intervention)
- Changes from baseline timed-up-and-go time at post 4-week training, post 8-week training, 6- and 12-month follow-ups(12 months after intervention)
- Changes from baseline five-times-sit-to-stand time at post 4-week training, post 8-week training, 6- and 12-month follow-ups(12 months after intervention)
- Changes from baseline comfortable gait speed at post 4-week training, post 8-week training, 6- and 12-month follow-ups(12 months after intervention)
- Changes from baseline one-leg stance time at post 4-week training, post 8-week training, 6- and 12-month follow-ups(12 months after intervention)
- Changes from baseline dual task timed-up-and-go time at post 4-week training, post 8-week training, 6- and 12-month follow-ups(12 months after intervention)
- Changes from baseline Activities-specific Balance Confidence Scale at post 4-week training, post 8-week training, 6- and 12-month follow-ups(12 months after intervention)
研究者
Margaret Kit Yi Mak
Associate Professor
The Hong Kong Polytechnic University