Effects of Aerobic Exercise in Parkinson's Disease

NCT00784563 | Completed Results DMC

• 1 other identifier: B6261-R
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Motivated by reported improvements in aerobic fitness and executive functions after a 6-month aerobic walking intervention in normal sedentary elderly, we conducted a Phase I/II study to investigate effects of aerobic exercise on motor function, cognition, and quality of life in mild-moderate patients with Parkinson's disease (PD). To identify the best method to deliver fitness training, we also aimed to compare safety, tolerability, and fitness benefits between different training methods (continuous/moderate intensity vs. interval/alternating between low and vigorous intensity) and exercise settings (individual vs. group). Interval training reportedly facilitates higher fitness gains than continuous training. Group training may promote success through social interaction, whereas individual training offers greater flexibility. Details of the study can be found in the publication below: Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2. PMID: 24991037

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Exercise/*physiology; *Physical Fitness; Rehabilitation; Cognition

Outcome Measures

Primary Outcomes (1)

• Change in Aerobic Fitness

  VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting). Please see publication PMID: 24991037 for details.

  6 months

Secondary Outcomes (7)

• Change in 7 Meter Walk Time

  6 months

• Change in the UPDRS Section I Score

  6 months

• Change in UPDRS Section II Score

  6 months

• Change in the UPDRS Section III Score

  6 months

• Change in the Total UPDRS Score

  6 months

Other Outcomes (4)

• Change in Fatigue Severity Scale Score

  6 months

• Change in Geriatric Depression Scale Score

  6 months

• Change in Parkinson's Disease Quality of Life Scale (PDQUALIF) Score

  6 months

Study Arms (2)

Continuous training

ACTIVE COMPARATOR

Aerobic walking using continuous heart rate training.

Behavioral: Continuous training

Interval training

ACTIVE COMPARATOR

Aerobic walking using interval heart rate training

Behavioral: Interval training

Interventions

Continuous training BEHAVIORAL

The maximal heart rate (HRmax) in the exercise prescription was based on age\[Goldberg, Elliot, and Kuehl1988\] and reduced by 20% in participants who used beta-blockers.\[Wonisch et al. 2003\] The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. The goal for continuous training was to remain within 70-80% of HRmax throughout the session.

Continuous training

Interval training BEHAVIORAL

Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking \[Wisloff et al. 2007\].

Interval training

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Iowa: collaborator

Study Sites (1)

VA Medical Center, Iowa City

Iowa City, Iowa, 52246-2208, United States

Location

Related Publications (1)

• Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.

  PMID: 24991037 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

We adapted our design in response to recruitment challenges and preliminary results over the course of the study. This uncontrolled study cannot prove efficacy, but provides guidance for a future Phase III study on aerobic exercise in PD.

Results Point of Contact

• Title: Ergun Y. Uc, MD
• Organization: Veterans Affairs Medical Center of Iowa City

ergun-uc@uiowa.edu

319-356-8753

Study Officials

• Ergun Y. Uc, MD

  VA Medical Center, Iowa City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 4, 2008
• Study Start: February 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 15, 2015
• Results First Posted: September 15, 2015

Record last verified: 2015-08

Locations

US (1)