Blood Flow Restriction for Optimizing Balance in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility metric
研究概览
简要总结
This study is being done to understand how reducing blood flow (BRT) during balance-challenging strengthening exercises (instability resistance training, or IRT) can help improve symptoms of Parkinson's disease.
详细描述
Parkinson's disease (PD) is a disease of the nervous system that attacks the nerve cells in the brain responsible for controlling movement in the arms, legs and face. It is a progressive condition that gets worse with time. The purpose of this study is to determine the effects of blood flow restriction (BFR) in combination with strengthening exercises that challenge balance (instability resistance training (IRT)) to improve the symptoms of the participant's condition. This research is being done to understand the effects of BFR with IRT on symptoms of PD such as balance, mobility, walking and endurance. There will be two groups 1 and 2; group 1 will perform IRT with BFR and group 2 will perform IRT only. Each session with either intervention will last approximately 45 minutes. Researchers will test the effects of the intervention on the participant's walking ability, balance function and endurance. The researchers hope to learn whether low resistance exercises using these tight cuffs around the thighs are well tolerated by individuals with PD and determine whether there is an improvement in muscle strength, balance, and physical function. In addition, researchers will also use peripheral nerve stimulation techniques which are non-invasive (does not go inside the body). These techniques will be used to measure spinal excitability (i.e., nerve stimulator for testing strength of the pathway between spinal cord and muscles) in individuals with PD.
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
- Double (Participant, Investigator)
盲法说明
This study will utilize block randomization with permuted blocks in a 1:1 ratio. Individuals will be assigned to either Group 1 or Group 2 after baseline assessment. The randomization will be predetermined, and the allocation will be concealed. Only the statistician and research coordinator will be aware of the randomization.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between the ages 40 - 85 with a diagnosis of idiopathic Parkinson's Disease (PD) consistent with the United Kingdom PD society brain bank criteria,
- •in Hoehn and Yahr stage 2-4,
- •a score of ≥23 on the mini-Mental Scale Examination.
排除标准
- •History of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), orthostatic hypotension, deep-vein thrombosis, varicose veins, or rhabdomyolysis;
- •Ankle branchial index ≤ 0.9 or > 1.
- •History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.
- •History of uncontrolled diabetes, severe osteoporosis, or cognitive impairment.
- •Body mass index above 40; such individuals are more likely to have poorer muscle function and more pain.
- •Absolute contraindications to exercise as per the American College of Sports Medicine (uncontrolled arrhythmias, third-degree heart block, recent electrocardiogram (EKG) changes, unstable angina, acute myocardial infarction, or acute congestive heart failure
- •Had surgery in the lower extremities within the past 6 months.
- •Pre-menopausal and not on birth control
- •Pregnant or planning to become pregnant within the course of the study
- •Plan to have major surgery within 2 months.
研究组 & 干预措施
BFR plus IRT Group
Blood Flow Restriction plus Instability Resistance Training group. Participants will receive 2 sessions per week over 6 weeks.
干预措施: Blood flow restriction training (Other)
BFR plus IRT Group
Blood Flow Restriction plus Instability Resistance Training group. Participants will receive 2 sessions per week over 6 weeks.
干预措施: Instability Resistance Training (Other)
IRT Only Control Group
Instability Resistance Training only group. Participants will receive 2 sessions per week over 6 weeks.
干预措施: Instability Resistance Training (Other)
结局指标
主要结局
Feasibility metric
时间窗: Baseline to 6 weeks
The treatment will be considered acceptable if the dropout and significant adverse event rate is less than 20%, that is no more than 2 out of 10 participants in the treatment group either 1) drop out, 2) withdraw consent, or 3) have a significant adverse event (Grade 3 or higher on 5 point scale where 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death). Results will be reported as percentage of participants that dropped out.
次要结局
- Balance Measure(Baseline to 14 weeks)
- Functional Mobility(Baseline to14 weeks)
- Postural Sway (Biosway)(Baseline to 14 weeks)
- Knee extensor muscle strength(Baseline to 14 weeks)
- Ankle plantar flexor muscle strength(Baseline to 14 weeks)
- Quality of Life PDQ-39 Questionnaire(Baseline to 14 weeks)
- Movement Disorder Society Unified Parkinson's Disease Rating Scale(Baseline to 14 weeks)
- Spinal Excitability Assessment(Baseline to 14 weeks)
- Hip abductor muscle strength(Baseline to 14 weeks)
研究者
Anjali Sivaramakrishnan
Principal Investigator
The University of Texas Health Science Center at San Antonio