NCT07221266 · University of Texas, El Paso
Changes in Movement, Fitness, and Quality of Life in People With Parkinson's Disease After Different Exercise Programs
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Guided Cycling
Participants will complete supervised cycling sessions on a stationary ergometer twice per week for eight weeks. Exercise intensity is based on each participant's lactate threshold as determined by cardiopulmonary exercise testing (CPET). Each 60-minute session includes a warm-up, cycling intervals of varying intensity, and a cool-down. Heart rate and perceived exertion are monitored continuously to ensure safety and adherence to prescribed intensity zones.
BEHAVIORAL
Non-Contact Boxing
Non-Contact Boxing Exercise Program Participants will engage in a structured, non-contact boxing program modeled after the Rock Steady Boxing® framework. Sessions are held twice weekly for eight weeks and include warm-up activities, agility and coordination drills, four boxing rounds using heavy and speed bags, and a circuit for balance and strength training. Each session concludes with a cool-down. All activities are supervised by licensed physical therapists trained in Parkinson's-specific exercise safety.
BEHAVIORAL
Traditional Physical Therapy Program (Standard of Care)
Participants in this group will receive multimodal physical therapy sessions twice per week for eight weeks. Each 60-minute session includes aerobic training (cycling or treadmill), resistance and balance exercises, gait training, and task-specific functional activities such as transfers and turning. Intensity is maintained at 60-85% of maximum heart rate, with continuous heart-rate monitoring. Sessions are led by a licensed physical therapist following standard clinical practice guidelines.
Primary outcome measures
Mini-BESTest Total Score
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 10, Week 15.
Parkinson's Disease Questionnaire-39 overall summary index; lower scores indicate better health-related quality of life.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- History of stroke
- History of heart attack
- Non-ambulatory
- Hoehn and Yahr of stage 4 or 5
- Osteoporosis
- Unmanaged Parkinson's medication
Where
- El Paso, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations