Changes in Movement, Fitness, and Quality of Life in People With Parkinson's Disease After Different Exercise Programs

Official title

Changes in Motor Function, Quality of Life, Cardiorespiratory Fitness, and Physiological Markers in People With Parkinson's Disease Following Different Exercise Interventions.

Overview

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:

1. Guided Cycling Group 2. Non-Contact Boxing Group 3. 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

1. 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. 2. 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. 3. 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.

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 ex
• 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.]
• Change in VO₂peak (mL/kg/min) During CPET [Time frame: Baseline, Week 10, Week 15.]
• PDQ-39 Summary Index [Time frame: Baseline, Week 10, Week 15.]

Secondary outcome measures (6)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• University of Texas at El Paso Doctor of Physical Therapy and Movement Sciences Building — El Paso
• Move Therapy Services — El Paso

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. PMID 34498995
• Gurovich 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. PMID 24916471
• Amara 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. PMID 29198450
• Sangarapillai 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. PMID 34121511
• Fang 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. PMID 36769234
• Adams 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. PMID 2016074
• Osborne 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. PMID 34963139
• Ridgel 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. PMID 19131578

Identifiers

NCT: NCT07221266 · 2310334

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗