Can High-intensity Exercise be Used to Treat Fatigue in Parkinson´s Disease?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in Modified Fatigue Impact Scale
研究概览
简要总结
The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease (PD).
The study will be a randomized multi-site controlled trial with follow up. Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle (control period).
It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue (i.e., clinical relevant reductions) when compared to the PD control group (primary hypothesis), and that these effects are sustained after 12-weeks of follow up (secondary hypothesis).
详细描述
Background:
Parkinson's disease (PD) is a neurodegenerative disorder characterized by progressive and disabling motor and non-motor symptoms. Worldwide, PD is the fastest growing neurological disorder. Medical and surgical approaches in the symptomatic treatment of PD are progressing, but currently no disease modifying therapies exist. While awaiting effective disease modifying therapies, there is a major need to optimise symptomatic treatments of disabling PD symptoms.
A recent survey among 678 persons with PD (pwPD) and 104 carer/partner/family members or friends identified "Fatigue and energy" as the non-motor symptom that, if improved, would make the most marked difference to their daily lives. Fatigue affects 30-70% (depending on definition) of pwPD, and has been associated with worse prognosis, depression, anxiety, poor sleep, limited working ability, social distancing, decreased physical activity and impaired quality of life. Nevertheless, no effective medical or non-medical treatments exist for fatigue in PD.
Generally, physical exercise is highly recommended as a symptomatic intervention in PD. In a recent survey, 19% of pwPD (n=195) reported exercise as a coping strategy for fatigue and approximately half of the participants (49.7%, n=511) reported that exercise improved fatigue. However, it was not specified whether exercise was used as an acute coping strategy that instantly reduced/prevented fatigue, or if it was used as a chronic coping strategy, where regular exercise sessions reduced the chronic fatigue level. In other populations a physical exercise session can acutely lower the perceived fatigue level, while increasing the perceived energy level. To our knowledge, no studies have so far investigated the acute effects of different types of high intensity exercise on fatigue in pwPD.
Diverging evidence exists on the effects of regular exercise on fatigue in PD. Two thirds of the existing studies cautiously suggest that exercise (i.e., dance, aerobic exercise, exergaming, and mixed modalities) can potentially improve perceived fatigue. However, the last third show no difference or even increased fatigue levels following an exercise intervention. These heterogeneous results may be due to poor study designs as only one study applied fatigue as the primary outcome making most existing studies at risk of being underpowered. Also, none of the studies applied "clinical fatigue" as an inclusion criterium, which might have led to an underestimation of the potential exercise effects. Lastly, most existing studies were based on small sample sizes (i.e., <30 participants), half included no control group and most interventions prescribed exercise with low to moderate intensity (rather than higher intensity exercise), potentially limiting the effects of the intervention. Consequently, there is a need for a new PD high intensity exercise study with stronger methodologies assessing the chronic effects on fatigue.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 40 years
- •Diagnosed with Idiopathic Parkinsons disease
- •Stable in medical treatment for six month
- •Able to transport themselves to and from exercise and testing sessions (with or without assistance)
- •H&Y score of three or lower
- •Exclusion criteria:
- •Performing high-intensity exercise more than two times per week
- •Significant medical comorbidities such as cardiovascular, respiratory, orthopedic, metabolic, or other neurological disorders
- •Cognitive dysfunction that prevents following or understanding instructions related to training and testing (answering questionnaires)
- •Known depression or alcohol abuse
排除标准
- 未提供
结局指标
主要结局
Change in Modified Fatigue Impact Scale
时间窗: Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only)
Questionnaire assessing the effects of fatigue on physical, cognitive and psychosocial functioning. The total score of the MFIS is the sum of the scores for the 21 items and ranges from 0 to 84. The ranges of scores for each subscale are as follows: physical, 0 to 36; cognitive, 0 to 40; and psychosocial, 0 to 8. A higher score represents a higher impact of fatigue, in general or in relation to one of the above mentioned areas
次要结局
- Change in Montreal Cognitive Assessment(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Muscle strength(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Parkinson's Fatigue Scale(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Fatigue Severity Scale(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Parkinson's Disease Questionnaire 39(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Baecke Habitual Physical Activity Questionnaire(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in European Quality of life - 5 Dimensions(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Six Minute Walk Test(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Timed Up and Go(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Pitchburg Sleep Quality Index(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Major Depression Inventory(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Brief Pain Inventory (Short Form)(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Non-motor Symptoms Questionnaire(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Six Spot Step Test(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Symbol Digit Modalities Test(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in aerobic capacity(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Physical activity(Baseline, 12 weeks post test, 24 weeks follow up test, 36 weeks post test (resistance exercise group only))
- Change in Rochester Fatigue Diary(3. exercise session (week 2 in the intervention period) and 30. exercise session (week 12 in the intervention period). One answer every hour for 24 hours (excluding sleeping hours).)
- Change in Visual Analog Scale for fatigue, tremor, bradykinesia, rigidity and postural instability(Monday, Wednesday and friday throughout the enrollment period (24 weeks for the aerobic exercise group and 36 weeks for the resistance exercise group))