Changes in Motor Function, Quality of Life, Cardiorespiratory Fitness, and Physiological Markers in People With Parkinson's Disease Following Different Exercise Interventions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Mini-BESTest Total Score
研究概览
简要总结
Parkinson's disease (PD) is a progressive neurological condition that can affect movement, balance, endurance, and overall quality of life. Exercise is widely recognized as one of the most effective non-pharmacological treatments to help people with PD maintain function and independence. However, not all exercise programs produce the same results, and more research is needed to understand which types of exercise offer the greatest physical and physiological benefits.
This study is designed to examine how different types of structured exercise programs influence motor function, cardiorespiratory fitness, and markers of overall health in individuals with Parkinson's disease. The goal is to better understand how exercise can be used to improve movement, daily activities, and general well-being, as well as how it affects the body at a physiological level.
Participants will be adults diagnosed with idiopathic Parkinson's disease who are medically stable and able to safely participate in exercise. Before beginning the study, participants will complete screening procedures to ensure safety and eligibility. Eligible participants will then be assigned to one of several supervised exercise interventions conducted over a defined period. Each exercise program is designed to improve movement and function but differs in structure or training emphasis (for example, aerobic, functional, or task-specific activity).
Exercise sessions will take place under the supervision of licensed physical therapist. Each session will include warm-up, exercise, and cool-down components. Intensity will be monitored using heart rate and perceived exertion to ensure safety and appropriate challenge. Participants will attend sessions multiple times per week for 8 weeks.
Researchers will collect information about movement abilities, balance, walking, endurance, and daily function using standardized physical therapy assessments such as gait tests, balance measures, and questionnaires related to quality of life at baseline, after 8-weeks of intervention and once more after a 4-week follow-up. In addition, blood samples will be collected to analyze physiological responses to exercise at the same 3 testing intervals. These samples will allow investigators to measure biomarkers related to cardiovascular health, nitric oxide availability, oxidative stress, and inflammation. These biological indicators can help identify how exercise affects underlying health mechanisms that may contribute to improved function in people with Parkinson's disease.
All data will be collected by trained research personnel who are experienced in working with individuals with Parkinson's disease. Participants will be monitored for safety at each session, and any adverse events will be documented and reviewed by the principal investigator and the Institutional Review Board (IRB).
By comparing changes across the different exercise programs, this study aims to determine which interventions have the most meaningful impact on mobility, endurance, and quality of life, as well as which ones produce measurable physiological benefits. Results from this research may help guide physical therapists, rehabilitation professionals, and people with Parkinson's disease in choosing the most effective exercise approaches for maintaining function and promoting overall health.
Ultimately, this project seeks to contribute to the growing evidence that targeted, engaging, and appropriately dosed exercise can play a key role in improving the lives of people living with Parkinson's disease. The findings may also help inform future clinical practice guidelines, community exercise programs, and long-term wellness strategies for individuals with movement disorders.
详细描述
This study is a randomized, controlled, parallel-group trial designed to evaluate the effects of three distinct exercise interventions in individuals with Parkinson's disease. The study compares guided cycling, non-contact boxing, and traditional physical therapy, each representing different approaches to exercise based on differences in intensity, motor demands, and cardiovascular engagement.
Participants will be randomly assigned to one of the three intervention groups using a computer-generated allocation process. Each participant will complete a structured intervention program consisting of supervised exercise sessions conducted twice weekly over an eight-week period. Interventions will be delivered in outpatient clinical and community-based settings under the supervision of licensed physical therapists, with exercise intensity and progression adjusted according to individual performance and tolerance.
The total duration of participation is approximately 15 weeks and includes baseline assessment, an intervention phase, post-intervention testing, and a follow-up assessment following a four-week washout period without structured exercise. This design allows for evaluation of both immediate responses to training and short-term retention of exercise-related adaptations.
The guided cycling intervention utilizes structured aerobic training performed on stationary ergometers, with workload adjusted based on individualized physiological responses. The non-contact boxing intervention incorporates large-amplitude, rhythmical, and task-specific movements designed to engage motor, cognitive, and cardiovascular systems simultaneously. The traditional physical therapy intervention reflects standard rehabilitation practice and includes a combination of aerobic conditioning, balance training, strengthening, and functional mobility exercises.
All intervention sessions will be supervised by licensed physical therapists with support from trained personnel to ensure consistency of delivery and participant safety. Monitoring procedures will be used across all intervention groups to assess participant response and guide appropriate modification of activity as needed.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's Disease
- •Independent ambulation
- •Hoehn and Yahr stage of 1-3
- •50 years of age or older
- •Must speak English or Spanish
排除标准
- •History of stroke
- •History of heart attack
- •Non-ambulatory
- •Hoehn and Yahr of stage 4 or 5
- •Osteoporosis
- •Unmanaged Parkinson's medication
研究组 & 干预措施
Guided Cycling
Participants in this group will complete supervised cycling sessions on a stationary ergometer twice per week for eight weeks. Exercise intensity will be based on each participant's lactate threshold, determined during cardiopulmonary exercise testing (CPET). Each session includes a warm-up, a 40-minute cycling protocol alternating low, moderate, and high intensities, and a cool-down. Heart rate and perceived exertion are continuously monitored.
干预措施: Guided Cycling (Behavioral)
Non-contact Boxing
Participants in this group will take part in a structured non-contact boxing program modeled after the Rock Steady Boxing® framework. Each 60-minute session includes warm-up, agility drills, four rounds of boxing activities (heavy bag, speed bag, mitt work, and double bag), balance circuits, and a cool-down. Sessions are led by a licensed physical therapist and certified boxing coach.
干预措施: Non-Contact Boxing (Behavioral)
Traditional Physical Therapy (Standard Care)
Participants in this group will receive standard physical therapy sessions that include aerobic, balance, strengthening, gait, and task-specific training exercises. Each session lasts approximately 60 minutes and is conducted twice weekly for eight weeks under the supervision of a licensed physical therapist. Exercise intensity is set between 60-85% of maximum heart rate, monitored throughout the session.
干预措施: Traditional Physical Therapy Program (Standard of Care) (Behavioral)
结局指标
主要结局
Mini-BESTest Total Score
时间窗: Baseline, Week 10, Week 15.
The Mini-Balance Evaluation Systems Test (Mini-BESTest) assesses anticipatory control, reactive postural control, sensory orientation, and dynamic gait. Total score range 0-28; higher scores indicate better balance.
Change in VO₂peak (mL/kg/min) During CPET
时间窗: Baseline, Week 10, Week 15.
Peak oxygen uptake measured by metabolic cart during graded cycle ergometry; higher values indicate greater cardiorespiratory fitness.
PDQ-39 Summary Index
时间窗: Baseline, Week 10, Week 15.
Parkinson's Disease Questionnaire-39 overall summary index; lower scores indicate better health-related quality of life.
次要结局
- 10-Meter Walk Test (10MWT) Speed(Baseline, Week 10, Week 15.)
- Tinetti Performance-Oriented Mobility Assessment (POMA) Score(Baseline, Week 10, Week 15.)
- Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) Score(Baseline, Week 10, Week 15.)
- Flow-Mediated Dilation (FMD) Percentage(Baseline, Week 10, Week 15.)
- Blood Biomarker Levels (NOx, CRP, TNF-α, Homocysteine, Vitamin B-12, 8-Isoprostane)(Baseline, Week 10, Week 15.)
- Blood Lactate Concentration During CPET(Baseline, Week 10, Week 15.)
研究者
Katherine Reyes-Brooks
Clinical Assistant Professor, Department of Physical Therapy and Movement Sciences
University of Texas, El Paso