Strength-Endurance Circuit Training in Parkinson's Disease: Effects on Disease Severity, Physical Performance, Blood Biomarkers and Quality of Life.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III.
研究概览
简要总结
The goal of this clinical trial is to determine whether adding strength training to aerobic training has a comparable or greater effect on the clinical status of Parkinson's disease patients than a standalone aerobic training.
- Does combined strength-endurance circuit training provide added benefits to physical performance, disease severity, blood biomarkers, and quality of life in PD patients compared to standalone aerobic training?
Participants will:
- undergo outcome measurements before and after the 12-week intervention and a 3-month follow-up measurement,
- visit the clinic twice a week for 1-hour training sessions.
- selected patients will be given a smartwatch with a pedometer that will count their average number of steps before, during and after the training period
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •diagnosis of idiopathic Parkinson´s disease
- •Hoehn-Yahr Scale ≤ 2,5
- •stable dopaminergic medication
排除标准
- •age ≥75 years
- •Hoehn-Yahr Scale ≥ 2,5
- •deep brain stimulation
- •presence of freezing
- •Camptocormia
- •inability to walk without support
- •inability to perform study procedures
- •limiting co-morbidities
- •attendance at training sessions below 70%
研究组 & 干预措施
Combined Strength-Endurance Circuit Training
干预措施: Strength-Endurance Training (Other)
Endurance Circuit Training
干预措施: Endurance Training (Other)
Control Group
结局指标
主要结局
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III.
时间窗: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)
The maximum total UPDRS score is 272, indicating the worst possible disability from PD. The minimum total score is 0, indicating no disability from PD. Improvement greater than (-4.9) points or worsening more than (+4.2) points on MDS-UPDRS II+III represent a minimal clinically important difference.
次要结局
- One Repetition Maximum (1RM)(From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up))
- Timed Up and Go Test (TUG)(From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up))
- Blood irisin levels(From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up))
- Cardiopulmonary Exercise Testing(From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up))
- The Parkinson's Disease Questionnaire (PDQ-39)(From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up))
- Blood brain-derived neurotrophic factor levels(From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up))
- Blood cytokine levels(From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up))
- Average number of steps(Average number of steps in the period before training (6 months), during the training period (3 months), period after training (3 months).)
研究者
Jakub Vítek
Physiotherapist
General University Hospital, Prague