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

NCT07221266 | Not Yet Recruiting

• 1 other identifier: 2310334
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Parkinson Disease (PD)

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, Week 10, Week 15.

Secondary Outcomes (6)

• 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.

Study Arms (3)

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.

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.

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.

Behavioral: Traditional Physical Therapy Program (Standard of Care)

Interventions

Guided Cycling BEHAVIORAL

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.

Guided Cycling

Non-Contact Boxing BEHAVIORAL

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.

Non-contact Boxing

Traditional Physical Therapy Program (Standard of Care) BEHAVIORAL

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.

Traditional Physical Therapy (Standard Care)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's Disease
• Independent ambulation
• Hoehn and Yahr stage of 1-3
• years of age or older
• Must speak English or Spanish

You may not qualify if:

• History of stroke
• History of heart attack
• Non-ambulatory
• Hoehn and Yahr of stage 4 or 5
• Osteoporosis
• Unmanaged Parkinson's medication

Sponsors & Collaborators

• University of Texas, El Paso: lead

Study Sites (2)

University of Texas at El Paso Doctor of Physical Therapy and Movement Sciences Building

El Paso, Texas, 79902, United States

Location

Move Therapy Services

El Paso, Texas, 79935, United States

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. 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.

  PMID: 36029042 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Inflammation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Katherine M Reyes-Brooks, PT, DPT

  University of Texas, El Paso

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine M Reyes-Brooks, PT, DPT

CONTACT

915-747-6122; kmreyesbrooks@utep.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Physical Therapy and Movement Sciences

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 27, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)