Motor and Cognitive Exercise in Parkinson's Disease. A Feasibility Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Feasibility: Intervention adherence
研究概览
简要总结
The aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone.
48 patients with PD and a symptom duration of 4 or more years will be randomized 1:1 to either a control arm or to an intervention arm. The control arm will have usual management of their PD. The intervention arm will receive exercises aimed at both motor and cognitive impairments of PD over the course of 12 weeks.
The study has been designed in partnership with the Copenhagen Trial Unit (CTU), Copenhagen Univeristy Hospital, to ensure both internal and external validity. To increase reproducibility, detailed protocols for all training modalities will be shared along with the study results.
This study is a feasibility study with the intention of a following international multi-center study to corroborate the results. Both feasibility outcomes for the intervention itself and clinical outcomes for the participants will be published.
详细描述
Intervention: The exercise program will consist of gait and balance training, lower body strength training and dual task training while treadmill walking. The program will include an individualized and progressive exercise program 3 times x 1 hour a week for 12 weeks with the following exercise modalities:
- Treadmill training for gait and balance training combined with dual task motor cognitive training.
- Progressive gait and motor-cognitive balance exercises
- Progressive resistance training including leg press.
The program will be conducted under supervision by a physiotherapist or an exercise physiologist. Usual treatment is permitted during the trial, both pharmacological and non-pharmacological. The treatment is preferably stable during the intervention and follow-up, but necessary changes will be registered.
All participants will be examined at baseline, after 12 weeks and again 6 and 12 months after baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Health personnel blinded to the allocation status will perform outcome-assessment at baseline and follow-up timepoints. The participants will be asked to conceal their allocation.
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
- •Diagnosis of PD according to MDS-PD criteria
- •Aged ≥ 18 years
- •Informed consent
- •PD symptoms ≥ 4 years
- •Independent gait
排除标准
- •Diagnosis of PD Dementia according to the MDS-PD Dementia criteria
研究组 & 干预措施
Control
The control arm will continue usual management (best medical treatment) of their PD and other potentiel comorbidities at the discretion of their regular physician and other health providers. Enrollment in this study will not influence any clinical decisions or potential changes in management.
干预措施: Usual Care (Other)
Intervention
The intervention arm will receive 3 weekly 1-hour sessions of multi-modal training over the course of 12 weeks, totaling 36 sessions, in addition to usual management (best medical treatment). As with the control arm, any clinical decisions or potential changes in management will not be influenced be enrollment in this study.
干预措施: Motor-cognitive exercise (Other)
结局指标
主要结局
Feasibility: Intervention adherence
时间窗: From allocation to the end of 12 weeks of intervention (T2)
Adherence defined as the proportion of participation in exercise sessions out of 36. A proportion of more than 60% will be considered acceptable.
Exploratory composite clinical outcome: Significant fall, all-cause hospitalization and all-cause mortality
时间窗: From enrollment to 1-year follow-up (T4)
A composite outcome of either death, unplanned hospitalization or a significant fall. A significant fall will be defined as a fall leading to an unplanned hospital contact or contact with the general practitioner. This composite outcome is based on binary events that will be registered at each pre-specified follow-up time.
次要结局
- Feasibility: Drop-out rate(Through study completion, an average of 1 year)
- Feasibility: Treatment fidelity(Through study completion, an average of 1 year)
- Feasibility: Missing data (primary clinical outcome)(From enrollment to 6-month follow-up (T3))
- Feasibility: Missing data (secondary clinical outcomes)(At baseline (T1), end of intervention at 12 weeks (T2), follow-up at 6 months (T3) and follow-up at 1 year (T4).)
- Feasibility: Randomization rate(From screening to baseline, up to 1 year.)
研究者
Annemette Lokkegaard
MD, PhD, Ass. Professor, Consultant Neurologist
University Hospital Bispebjerg and Frederiksberg