Effects of Aerobic Exercise in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00784563
First received: October 30, 2008
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

Aerobic exercise has the potential to become an effective and easily accessible treatment for Parkinson's disease (PD) that can improve both cognitive and motor dysfunction. This project will help us to understand the mechanism and scope of benefits from aerobic exercise in PD. Our proposed preliminary clinical trial is aimed at determining the safest and most tolerable aerobic exercise intervention (6 months)with best neurobiological activity so that this intervention can be tested for efficacy in a subsequent definitive clinical trial.


Condition Intervention Phase
Parkinson Disease
Behavioral: aerobic exercise in the form of brisk walking
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Exercise in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in cognition, motor function, quality of life, brain function/structure and biomarkers in response to expected change in fitness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiac fitness in response to exercise intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • safety and tolerability of the intervention [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
group/continuous
Behavioral: aerobic exercise in the form of brisk walking
We will randomize subjects to 4 intervention arms (group/continuous, group/interval, single/continuous, and single/interval). Exercise programs, each designed to deliver a similar workload per session, will be conducted 3 times per week for 6 months.
Active Comparator: Arm 2
group/interval
Behavioral: aerobic exercise in the form of brisk walking
We will randomize subjects to 4 intervention arms (group/continuous, group/interval, single/continuous, and single/interval). Exercise programs, each designed to deliver a similar workload per session, will be conducted 3 times per week for 6 months.
Active Comparator: Arm 3
single/continuous
Behavioral: aerobic exercise in the form of brisk walking
We will randomize subjects to 4 intervention arms (group/continuous, group/interval, single/continuous, and single/interval). Exercise programs, each designed to deliver a similar workload per session, will be conducted 3 times per week for 6 months.
Active Comparator: Arm 4
single/interval
Behavioral: aerobic exercise in the form of brisk walking
We will randomize subjects to 4 intervention arms (group/continuous, group/interval, single/continuous, and single/interval). Exercise programs, each designed to deliver a similar workload per session, will be conducted 3 times per week for 6 months.

Detailed Description:

Background. Many patients with Parkinson's disease (PD), even in the early stages, suffer from cognitive (especially executive and visuospatial) dysfunction, which can impair critical activities of daily living such as driving. Modest increases in cardiovascular fitness with aerobic exercise improve executive functions and visuospatial abilities in the elderly, possibly by enhanced neuroplasticity due to increase of trophic factors and reduction of inflammatory processes in the brain. Preliminary studies have shown that mild-moderate PD patients tolerate aerobic exercise programs and show cardiovascular fitness and motor function improvements.

Preliminary data. In a cross-sectional pilot study of independently living, fully ambulatory PD patients across a spectrum of physical activity levels, we found that cardiovascular fitness (as indexed by VO2max) was an independent predictor of executive functions, visuospatial abilities, walking speed, level of physical activity, and activities of daily living, even after adjusting for age, education, and motor severity of PD. Subjects with greater fitness and better performance on an executive function task had more favorable activation patterns on fMRI, and tended to have greater brain volumes in regions important for cognition on volumetric MRI.

Hypotheses for this preliminary (Phase I/II) clinical trial:

  1. Aerobic exercise intervention in the form of brisk walking will improve cardiovascular fitness (i.e., increase VO2max), which will be associated with increase in trophic factors, decrease in inflammatory markers, favorable changes in activation patterns on functional magnetic resonance imaging (MRI) during executive function tasks, and increased volumes of brain regions relevant for executive functions on morphometric MRI.
  2. Aerobic exercise programs using different training formats and settings will have different safety (adverse effects such as cardiopulmonary events, falls), tolerability (compliance, retention, subject impressions), and neurobiological activity.

We will also establish inclusion and exclusion criteria for the subsequent definitive efficacy trial by identifying the demographic, cardiovascular fitness, cognitive and motor function profiles of participants who display an optimal balance of safety, tolerability, and favorable neurobiological effects in this preliminary trial.

Design. We will enroll independently living, fully ambulatory, non-demented PD patients (ages 50-80) who are not on an aerobic exercise program. We will investigate effects of heart rate training format (continuous vs. interval) and exercise setting (group vs. individual at home) . Exercise programs will be conducted 3 times per week for 6 months. Exercise test by cycle ergometry, functional and morphometric MRI, trophic factor and biomarker assays, safety exams and labs (ECG, biochemistry, CBC), tests of parkinsonism and cognition, questionnaires about quality of life, mood, and activities of daily living will be administered at baseline and after the exercise program.

Conclusion. Aerobic exercise has the potential to become an effective and easily accessible treatment for PD that can improve both cognitive and motor dysfunction. Our proposed study aims to understand the mechanism of benefits from aerobic exercise in PD and to optimize this intervention for a definitive clinical trial.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veteran or non-veteran;
  • Presence of all 3 cardinal features of Parkinson's disease (resting tremor, bradykinesia, and rigidity), which have to be asymmetrical;
  • Hoehn and Yahr Scale stage I-III;
  • Men or women aged 50-80 capable of performing the planned exercise programs;
  • Intention to remain in the local area over the study period;
  • Stable dopaminergic treatment regimen for at least 4 weeks prior to baseline without any clinical need for medication adjustment at the time of screening

Exclusion Criteria:

  • Secondary parkinsonism;
  • Parkinson-plus syndromes;
  • MMSE score <24;
  • Participating in a aerobic exercise program;
  • An unstable dosage of drugs active in the central nervous system (e.g., anxiolytics, antidepressants) during the 60 days before the baseline visit;
  • Participation in drug studies or the use of investigational drugs within 30 days before screening; structural brain disease;
  • Active epilepsy;
  • Acute illness or active, confounding medical, neurological, or musculoskeletal conditions; alcoholism or other forms of drug addiction;
  • Inability to complete the graded exercise test;
  • Lack of medical clearance from our pulmonologist;
  • Intention to move or take a >1 month vacation during the study period;
  • Contraindications to MRI or claustrophobia requiring sedation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784563

Locations
United States, Iowa
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Ergun Y. Uc, MD VA Medical Center, Iowa City
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00784563     History of Changes
Other Study ID Numbers: B6261-R
Study First Received: October 30, 2008
Last Updated: May 18, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Parkinson Disease
Exercise/*physiology
*Physical Fitness
Rehabilitation
Cognition

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 23, 2014