Parkinson Disease (PD)NCT07221266
Changes in Movement, Fitness, and Quality of Life in People With Parkinson's Disease After Different Exercise Programs
A study testing Guided Cycling and Non-Contact Boxing in people with Parkinson Disease (PD), run by University of Texas, El Paso at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Guided Cycling and Non-Contact Boxing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of stroke
- History of heart attack
- Non-ambulatory
- Hoehn and Yahr of stage 4 or 5
- Osteoporosis
- Unmanaged Parkinson's medication
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Texas at El Paso Doctor of Physical Therapy and Movement Sciences Building
El Paso, Texas, 79902
Alvaro Gurovich, PT, PhD, 915-747-7248, agurovich@utep.edu
- Recruiting
Move Therapy Services
El Paso, Texas, 79935
Katherine M Reyes-Brooks, PT, DPT, 915-307-3283, movetherapy@outlook.com
About this study
Official title: Changes in Motor Function, Quality of Life, Cardiorespiratory Fitness, and Physiological Markers in People With Parkinson's Disease Following Different Exercise Interventions.
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.
Read more
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.
Read the detailed description
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.
This study is conducted within a collaborative clinical and academic framework to support standardized implementation of interventions and data collection. The findings are intended to improve understanding of how different exercise strategies may influence adaptation in individuals with Parkinson's disease and to inform the development of more targeted rehabilitation approaches.
Study Design
This is a single-site, randomized, controlled, interventional trial conducted in El Paso, Texas, with collaboration between the University of Texas at El Paso (UTEP) and MOVE Therapy Services. Participants will be randomized (computer-generated block randomization) into one of three intervention arms:
- Guided Cycling Group
- Non-Contact Boxing Group
- Traditional Physical Therapy (Standard Care) Group
The total duration for each participant is 15 weeks, consisting of:
- Week 1: Baseline testing
- Weeks 2-9: 8-week intervention (two 60-minute sessions per week)
- Week 10: Post-intervention testing
- Weeks 11-14: Four-week rest/washout
- Week 15: Final follow-up testing
All sessions will be led by licensed physical therapists with assistance from trained Doctor of Physical Therapy (DPT) students. Data collection will occur at UTEP's Rehabilitation Sciences Complex for the cycling and physical therapy groups, and at MOVE Therapy Services for the boxing group.
Intervention Descriptions
- Non-Contact Boxing: This intervention emphasizes large-amplitude, rhythmical, and task-specific movements that combine cognitive, motor, and cardiovascular elements. Sessions include warm-up, boxing rounds (heavy bag, speed bag, mitt work), agility and balance circuits, and cool-down routines. Participants wear gloves, engage in multi-directional footwork, and perform high-intensity drills under therapist supervision. HR and BP are continuously monitored for safety.
- Guided Cycling: This program uses stationary cycle ergometers (Lode Corival) with intensity determined by participants' lactate threshold, established through cardiopulmonary exercise testing (CPET). Each session includes a warm-up, 40-minute cycling component with alternating low, moderate, and high-intensity bouts, and a cool-down. HR and RPE are recorded throughout. Lactate micro-sampling from the earlobe is used periodically to confirm workloads within prescribed zones.
- Traditional Physical Therapy (Standard Care):
This intervention incorporates multimodal training emphasizing aerobic exercise, resistance and balance training, gait practice, and task-specific functional activities. Intensity is set between 60-85% HRmax, adjusted by perceived exertion and HR monitoring. Each session includes warm-up, treadmill or cycling intervals, balance tasks with and without visual cues, strength training, and community-oriented gait exercises. Safety is ensured through therapist supervision, gait belts, and appropriate rest breaks.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Guided Cycling, Non-Contact Boxing, Traditional Physical Therapy Program (Standard of Care)
- Keywords
- Parkinson's Disease, Exercise intervention, Physical Therapy, Guided Cycling, Non-contact boxing, Aerobic Exercise, Quality of Life, Endothelial Function, Blood Biomarkers, Homocysteine, Vitamin B-12, Inflammation, Oxidative stress, Balance Training, Motor Function
- Medical subject headings
- Parkinson Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided CyclingBehavioural
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.
Non-Contact BoxingBehavioural
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.
Traditional Physical Therapy Program (Standard of Care)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Cycling | Experimental | 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. Receives: Behavioral: Guided Cycling |
| Non-contact Boxing | Experimental | 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. Receives: Behavioral: Non-Contact Boxing |
| Traditional Physical Therapy (Standard Care) | Active comparator | 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. Receives: Behavioral: Traditional Physical Therapy Program (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-BESTest Total Score
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.
Measured: Baseline, Week 10, Week 15.
Change in VO₂peak (mL/kg/min) During CPET
Peak oxygen uptake measured by metabolic cart during graded cycle ergometry; higher values indicate greater cardiorespiratory fitness.
Measured: Baseline, Week 10, Week 15.
PDQ-39 Summary Index
Parkinson's Disease Questionnaire-39 overall summary index; lower scores indicate better health-related quality of life.
Measured: Baseline, Week 10, Week 15.
Secondary outcomes (6)
10-Meter Walk Test (10MWT) Speed
The 10MWT measures gait speed in meters per second over a 10-meter distance. Increased speed indicates improved walking ability.
Measured: Baseline, Week 10, Week 15.
Tinetti Performance-Oriented Mobility Assessment (POMA) Score
The POMA evaluates balance and gait function. Scores range from 0-28, with higher scores reflecting improved mobility and reduced fall risk.
Measured: Baseline, Week 10, Week 15.
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) Score
The mCTSIB assesses postural stability under four sensory conditions. Longer hold times indicate improved sensory integration and balance.
Measured: Baseline, Week 10, Week 15.
Flow-Mediated Dilation (FMD) Percentage
Endothelial function will be evaluated by ultrasound measurement of brachial artery diameter changes after occlusion. Greater FMD percentage indicates improved vascular function.
Measured: Baseline, Week 10, Week 15.
Blood Biomarker Levels (NOx, CRP, TNF-α, Homocysteine, Vitamin B-12, 8-Isoprostane)
Venous blood samples will be analyzed for nitric oxide bioavailability (NOx), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), homocysteine, vitamin B-12, and oxidative stress marker 8-isoprostane. These biomarkers reflect inflammatory and metabolic responses to exercise.
Measured: Baseline, Week 10, Week 15.
Blood Lactate Concentration During CPET
Blood lactate levels (mmol/L) will be collected through micro-sampling from the earlobe during graded exercise testing. A rightward shift in lactate threshold indicates improved metabolic efficiency.
Measured: Baseline, Week 10, Week 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start21 Apr 2026
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Reyes-Brooks, University of Texas, El Paso
- Investigators
- Katherine M Reyes-Brooks, PT, DPT, Principal investigator, University of Texas, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221266
- Sponsor's protocol ID
- 2310334
- Status last verified
- May 2026
- First submitted
- 23 Oct 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available without identifiers upon request.
Publications
Larson D, Yeh C, Rafferty M, Bega D. High satisfaction and improved quality of life with Rock Steady Boxing in Parkinson's disease: results of a large-scale survey. Disabil Rehabil. 2022 Oct;44(20):6034-6041. doi: 10.1080/09638288.2021.1963854. Epub 2021 Sep 9.
PubMed 34498995Gurovich AN, Avery JC, Holtgrieve NB, Braith RW. Flow-mediated dilation is associated with endothelial oxidative stress in human venous endothelial cells. Vasc Med. 2014 Aug;19(4):251-256. doi: 10.1177/1358863X14537546. Epub 2014 Jun 10.
PubMed 24916471Amara AW, Memon AA. Effects of Exercise on Non-motor Symptoms in Parkinson's Disease. Clin Ther. 2018 Jan;40(1):8-15. doi: 10.1016/j.clinthera.2017.11.004. Epub 2017 Dec 1.
PubMed 29198450Sangarapillai K, Norman BM, Almeida QJ. Boxing vs Sensory Exercise for Parkinson's Disease: A Double-Blinded Randomized Controlled Trial. Neurorehabil Neural Repair. 2021 Sep;35(9):769-777. doi: 10.1177/15459683211023197. Epub 2021 Jun 13.
PubMed 34121511Fang YC, Hsieh YC, Hu CJ, Tu YK. Endothelial Dysfunction in Neurodegenerative Diseases. Int J Mol Sci. 2023 Feb 2;24(3):2909. doi: 10.3390/ijms24032909.
PubMed 36769234Adams JD Jr, Odunze IN. Oxygen free radicals and Parkinson's disease. Free Radic Biol Med. 1991;10(2):161-9. doi: 10.1016/0891-5849(91)90009-r.
PubMed 2016074Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302.
PubMed 34963139Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):600-8. doi: 10.1177/1545968308328726. Epub 2009 Jan 8.
PubMed 19131578Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Correction to: Osborne JA, Botkin R, Colon-Semenza C, et al. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022;102:pzab302. https://doi.org/10.1093/ptj/pzab302. Phys Ther. 2022 Aug 1;102(8):pzac098. doi: 10.1093/ptj/pzac098. No abstract available.
PubMed 36029042
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Motor Function, Quality of Life, Cardiorespiratory Fitness, and Physiological Markers in People With Parkinson's Disease Following Different Exercise Interventions.
- ClinicalTrials.gov ID
- NCT07221266
- Acronym / sponsor ID
- 2310334
- Conditions
- Parkinson Disease (PD)
- Keywords
- Parkinson's Disease, Exercise intervention, Physical Therapy, Guided Cycling, Non-contact boxing, Aerobic Exercise, Quality of Life, Endothelial Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Texas, El PasoUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This study is conducted within a collaborative clinical and academic framework to support standardized implementation of interventions and data collection. The findings are intended to improve understanding of how different exercise strategies may influence adaptation in individuals with Parkinson's disease and to inform the development of more targeted rehabilitation approaches.
Study Design
This is a single-site, randomized, controlled, interventional trial conducted in El Paso, Texas, with collaboration between the University of Texas at El Paso (UTEP) and MOVE Therapy Services. Participants will be randomized (computer-generated block randomization) into one of three intervention arms:
- Guided Cycling Group
- Non-Contact Boxing Group
- Traditional Physical Therapy (Standard Care) Group
The total duration for each participant is 15 weeks, consisting of:
- Week 1: Baseline testing
- Weeks 2-9: 8-week intervention (two 60-minute sessions per week)
- Week 10: Post-intervention testing
- Weeks 11-14: Four-week rest/washout
- Week 15: Final follow-up testing
All sessions will be led by licensed physical therapists with assistance from trained Doctor of Physical Therapy (DPT) students. Data collection will occur at UTEP's Rehabilitation Sciences Complex for the cycling and physical therapy groups, and at MOVE Therapy Services for the boxing group.
Intervention Descriptions
- Non-Contact Boxing: This intervention emphasizes large-amplitude, rhythmical, and task-specific movements that combine cognitive, motor, and cardiovascular elements. Sessions include warm-up, boxing rounds (heavy bag, speed bag, mitt work), agility and balance circuits, and cool-down routines. Participants wear gloves, engage in multi-directional footwork, and perform high-intensity drills under therapist supervision. HR and BP are continuously monitored for safety.
- Guided Cycling: This program uses stationary cycle ergometers (Lode Corival) with intensity determined by participants' lactate threshold, established through cardiopulmonary exercise testing (CPET). Each session includes a warm-up, 40-minute cycling component with alternating low, moderate, and high-intensity bouts, and a cool-down. HR and RPE are recorded throughout. Lactate micro-sampling from the earlobe is used periodically to confirm workloads within prescribed zones.
- Traditional Physical Therapy (Standard Care):
This intervention incorporates multimodal training emphasizing aerobic exercise, resistance and balance training, gait practice, and task-specific functional activities. Intensity is set between 60-85% HRmax, adjusted by perceived exertion and HR monitoring. Each session includes warm-up, treadmill or cycling intervals, balance tasks with and without visual cues, strength training, and community-oriented gait exercises. Safety is ensured through therapist supervision, gait belts, and appropriate rest breaks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Cycling | Experimental | Behavioral: Guided CyclingParticipants 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. |
| Non-contact Boxing | Experimental | Behavioral: Non-Contact BoxingParticipants 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. |
| Traditional Physical Therapy (Standard Care) | Active comparator | Behavioral: Traditional Physical Therapy Program (Standard of 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- History of stroke
- History of heart attack
- Non-ambulatory
- Hoehn and Yahr of stage 4 or 5
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided CyclingParticipants 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. | Behavioural | Guided Cycling |
| Non-Contact BoxingNon-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. | Behavioural | Non-contact Boxing |
| 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. | Behavioural | Traditional Physical Therapy (Standard Care) |
Primary outcome
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.
6 secondary outcomes
10-Meter Walk Test (10MWT) Speed
Time frame: Baseline, Week 10, Week 15.
Tinetti Performance-Oriented Mobility Assessment (POMA) Score
Time frame: Baseline, Week 10, Week 15.
Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) Score
Time frame: Baseline, Week 10, Week 15.
Flow-Mediated Dilation (FMD) Percentage
Time frame: Baseline, Week 10, Week 15.
Blood Biomarker Levels (NOx, CRP, TNF-α, Homocysteine, Vitamin B-12, 8-Isoprostane)
Time frame: Baseline, Week 10, Week 15.
Blood Lactate Concentration During CPET
Time frame: Baseline, Week 10, Week 15.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 34498995Larson D, Yeh C, Rafferty M, Bega D. High satisfaction and improved quality of life with Rock Steady Boxing in Parkinson's disease: results of a large-scale survey. Disabil Rehabil. 2022 Oct;44(20):6034-6041. doi: 10.1080/09638288.2021.1963854. Epub 2021 Sep 9.
- Background: PubMed 24916471Gurovich AN, Avery JC, Holtgrieve NB, Braith RW. Flow-mediated dilation is associated with endothelial oxidative stress in human venous endothelial cells. Vasc Med. 2014 Aug;19(4):251-256. doi: 10.1177/1358863X14537546. Epub 2014 Jun 10.
- Background: PubMed 29198450Amara AW, Memon AA. Effects of Exercise on Non-motor Symptoms in Parkinson's Disease. Clin Ther. 2018 Jan;40(1):8-15. doi: 10.1016/j.clinthera.2017.11.004. Epub 2017 Dec 1.
- Background: PubMed 34121511Sangarapillai K, Norman BM, Almeida QJ. Boxing vs Sensory Exercise for Parkinson's Disease: A Double-Blinded Randomized Controlled Trial. Neurorehabil Neural Repair. 2021 Sep;35(9):769-777. doi: 10.1177/15459683211023197. Epub 2021 Jun 13.
- Background: PubMed 36769234Fang YC, Hsieh YC, Hu CJ, Tu YK. Endothelial Dysfunction in Neurodegenerative Diseases. Int J Mol Sci. 2023 Feb 2;24(3):2909. doi: 10.3390/ijms24032909.
- Background: PubMed 2016074Adams JD Jr, Odunze IN. Oxygen free radicals and Parkinson's disease. Free Radic Biol Med. 1991;10(2):161-9. doi: 10.1016/0891-5849(91)90009-r.
- Background: PubMed 34963139Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302.
- Background: PubMed 19131578Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):600-8. doi: 10.1177/1545968308328726. Epub 2009 Jan 8.
- Background: PubMed 36029042Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Correction to: Osborne JA, Botkin R, Colon-Semenza C, et al. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022;102:pzab302. https://doi.org/10.1093/ptj/pzab302. Phys Ther. 2022 Aug 1;102(8):pzac098. doi: 10.1093/ptj/pzac098. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data will be available without identifiers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine M Reyes-Brooks, PT, DPT principal investigator
University of Texas, El Paso
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Cycling and Non-Contact Boxing in people with Parkinson Disease (PD), run by University of Texas, El Paso at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine M Reyes-Brooks, PT, DPT (915-747-6122, kmreyesbrooks@utep.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-BESTest Total Score (time frame: Baseline, Week 10, Week 15.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07221266, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.