Longer-term Exercise Interventions in People With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in Two minute walk from baseline at 3 months
研究概览
简要总结
This study sets out to determine the effect of exercise performed over a longer period of time (6 months), delivered using community facilities, on motor and non motor symptoms, health and well being in people with Parkinson's Disease.
详细描述
Participation in exercise is beneficial for health and well being, but the effect over a longer period of time in people with Parkinson's disease (PD) has not been established. People with PD currently only receive short-term support for exercise therapy interventions funded from the National Health Service; it is therefore unsurprising that people with PD are observed to have low levels of physical activity that decrease over time.
Using mixed methodology the investigators will explore the effect of exercise delivered over a longer period of time (six months) in people with PD. The investigators will examine the views of people participating in the program.
Aims
Using a randomized controlled trial with one intervention arm and an active comparator control group with blinded assessments and semi-structured interview techniques the investigators will determine in people with PD:
- The effect of longer-term exercise participation on motor symptoms
- The effect of longer-term exercise participation on non motor symptoms, fitness, health and well being.
- Participants views of the process and sustainability of community provision of exercise over a longer period of time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease diagnosed by neurological examination; idiopathic PD defined by the UK Parkinson's Disease Society Brain Bank Criteria
- •Able to walk ≥ 100m
- •maintained a stable medical regime for 12 weeks prior to initiation of the study, and anticipated to maintain a stable regime for the course of study (as determined by the referring clinician).
排除标准
- •History of additional prior neurological condition
- •Severe depression or psychosis or a mental state that would preclude consistent active involvement with the study over its duration
- •Cardiac precautions that would prevent the subject from completing the exercise program or the full battery of outcome measures
- •Any known contraindication to exercise
- •Reduced cognition of any cause [Minimental state examination [(MMSE) < 23]
- •An orthopaedic condition that independently limits walking;
结局指标
主要结局
Change in Two minute walk from baseline at 3 months
时间窗: baseline and 3 months
Distance covered in 2 minutes by walking at self selected speed
Change in Two minute walk from 3 months at 6 months
时间窗: 3 months and 6 months
Distance covered in 2 minutes by walking at self selected speed
Change in Two minute walk from 6 months at 12 months
时间窗: 6 months and 12 months
Distance covered in 2 minutes by walking at self selected speed
次要结局
- Change in Blood Pressure from baseline at 3 months(baseline and 3 months)
- Change in Time Up and Go (TUG) from baseline at 3 months(baseline and 3 months)
- Change in Disease Status from baseline at 3 months(baseline and 3 months)
- Change in SF-36 from baseline at 3 months(baseline and 3 months)
- Change in EQ-5D from baseline at 3 months(Baseline and 3 months)
- Change in Body Mass Index from baseline at 3 months(baseline and 3 months)
- Change in Nine hole peg test from baseline at 3 months(baseline and 3 months)
- Change in Prescribed medication from baseline at 3 months(baseline and 3 months)
- Change in Leg power from baseline at 3 months(baseline and 3 months)
- Change in Non-motor symptoms from baseline at 3 months(baseline and 3 months)
- change in reported Physical Activity from baseline at 3 months(baseline and 3 months)
- Change measured physical activity from baseline at 3 months(baseline and 3 months)
- Change in Nine hole peg test from 6 months at 12 months(6 months and 12 months)
- Change in SF-36 from 6 months at 12 months(6 months and 12 months)
- Change in EQ-5D from 3 months at 6 months(3 months and 6 months)
- Change in aerobic fitness from baseline at 3 months(baseline and 3 months)
- Change in Grip Strength from baseline at 3 months(baseline and 3 months)
- Adherence(Particpants will be followed at each scheduled session for the duration of the intervention (6 months 2 x a week))
- Change in Prescribed medication from 3 months at 6 months(3 months and 6 months)
- Change in Time Up and Go (TUG) from 6 months at 12 months(6 months and 12 months)
- Change in Nine hole peg test from 3 months at 6 months(3 months and 6 months)
- Change in Blood Pressure from 6 months at 12 months(6 months and 12 months)
- Change in aerobic fitness from 6 months at 12 months(6 months and 12 months)
- Process Evaluation(6 months (end intervention))
- Change in Blood Pressure from 3 months at 6 months(3 months and 6 months)
- Change in Grip Strength from 3 months at 6 months(3 months and 6 months)
- Change in Non-motor symptoms from 6 months at 12 months(6 months and 12 months)
- Change in Time Up and Go (TUG) from 3 months at 6 months(3 months and 6 months)
- Change in SF-36 from 3 months at 6 months(3 months and 6 months)
- Change in Body Mass Index from 6 months at 12 months(6 months and 12 months)
- Change in EQ-5D from 6 months at 12 months(6 months and 12 months)
- Change in Prescribed medication from 6 months at 12 months(6 months and 12 months)
- Change in Leg power from 3 months at 6 months(3 months and 6 months)
- Change in Leg power from 6 months at 12 months(6 months and 12 months)
- Change in Grip Strength from 6 months at 12 months(6 months and 12 months)
- Change measured physical activity from 3 months at 6 months(3 months and 6 months)
- Change in reported Physical Activity from 6 months at 12 months(6 months and 12 months)
- Change upper limb function from 3 months at 6 months(3 months and 6 months)
- Change in Disease Status from 3 months at 6 months(3 months and 6 months)
- Change in Disease Status from 6 months at 12 months(6 months and 12 months)
- Change in Non-motor symptoms from 3 months at 6 months(3 months and 6 months)
- Change in reported Physical Activity from 3 months at 6 months(3 months and 6 months)
- Change measured physical activity from 6 months at 12 months(6 months and 12 months)
- Change in FSS from baseline at 3 months(baseline and 3 months)
- Change in FSS from 6 months at 12 months(6 months and 12 months)
- Change in FSS from 3 months at 6 months(3 months and 6 months)
- Change upper limb function from baseline at 3 months(baseline and 3 months)
- Change upper limb function from 6 months at 12 months(6 months and12months)
研究者
Dr Johnny Collett
Research Fellow
Oxford Brookes University