Strength Training as an Add-on to Standard Pharmacotherapy in Patients with Parkinsons Disease: A Randomized Controlled Biomarker Trial (SToP-PD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Comparison of changes in muscle strength, motor function and cognition between standard treatment versus add-on strength training (ST) for evaluation of efficacy of ST.
研究概览
简要总结
Rationale/ gaps in existing knowledge: Parkinson’s Disease (PD) currently affects around 1% of the population over sixty years of age, however, prevalence is expected to increase. In preliminary studies, lower limb strength training was effective at alleviating motor symptoms of PD, when used in conjunction with standard pharmacotherapy. The proposed study will provide definitive data on the efficacy and safety of strength training in PD patients, with particular relevance to India.
Novelty: In addition to assessing efficacy and safety in the first ever randomized controlled trial (RCT) of strength training in India, the current study will throw light on novel mechanistic aspects, focussing on neural adaptations underpinning strength training. For the first time, we will explore the role of the Reticulospinal Tract (RST) in improving strength and motor symptoms in PD.
Objectives: Assess the safety and efficacy of strength training as an add-on to standard pharmacotherapy for improvement of motor function, gait, selective non-motor functions in PD patients. Additionally, we will elucidate the mechanism of improvement through changes in molecular and electrophysiological biomarkers following strength training.
Methods: A randomized controlled trial will be conducted on PD patients with gait impairment. The patients will be assigned to either strength training or no physical therapy groups in addition to stable dose of standard medications for 12 weeks. Clinical, electrophysiological outcomes and molecular biomarkers will be assessed at baseline and at 12 weeks. A post-treatment follow-up visit will be performed on active intervention group for similar assessments at week 24 to find out any carryover effect of strength training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals diagnosed with Idiopathic Parkinsons disease according to MDS clinical diagnostic criteria.
- •Patients of either sex between the age of 40 to 75 years and Hoehn and Yahr stages 1 to 3 who can stand unassisted for two minutes and having a clinically apparent gait problem will be included in the study.
- •Patients will require access to smartphone for AV recording and viewing the training program.
- •Patient must have a study partner who will assist him/ her in the domiciliary training sessions.
排除标准
- •PD patients with dyskinesia will not be enrolled.
- •Patients with significant musculoskeletal problems or chronic pain, which might be aggravated by training or interfere with the outcome as perceived by the PI/ Co-I, will be excluded.
- •Patients with a neurological disease other than PD or other physical impairments that would prevent participation in the muscular strength testing will be excluded on screening.
- •PD patients with uncontrolled systemic diseases (e.g. hypertension, heart diseases, etc.) or significant cognitive impairment or refractory psychiatric symptoms will also be excluded, as will those who are already participating in a structured exercise program (including yoga, regular supervised/unsupervised stretching, or aerobic training).
- •However, those who walk for their fitness regularly, may be included in the study.
结局指标
主要结局
Comparison of changes in muscle strength, motor function and cognition between standard treatment versus add-on strength training (ST) for evaluation of efficacy of ST.
时间窗: Day 0, week 4, week 8, week 12 (for all) and week 24 (for active intervention group)
次要结局
- Comparison of changes in electrophysiological biomarkers between standard treatment versus add-on strength training (ST) to understand the mechanism of strength training.(Day 0, week 4, week 8, week 12 (for all) and week 24 (for active intervention group))
- Comparison of reported adverse event frequency and other safety parameters between standard treatment versus add-on strength training (ST) for evaluation of safety of ST.(Day 0, week 4, week 8, week 12 (for all) and week 24 (for active intervention group))
- Comparison of changes in molecular biomarkers between standard treatment versus add-on strength training (ST) to understand the mechanism of strength training.(Day 0, week 12 (for all) and week 24 (for active intervention group))
研究者
Dr Supriyo Choudhury
Institute of Neurosciences Kolkata