Effects of Aerobic Exercise in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
University of Iowa
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00784563
First received: October 30, 2008
Last updated: August 25, 2015
Last verified: August 2015
  Purpose

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


Condition Intervention
Parkinson Disease
Behavioral: Continuous training
Behavioral: Interval training

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 VA Office of Research and Development:

Primary Outcome Measures:
  • Change in Aerobic Fitness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting).

    Please see publication PMID: 24991037 for details.



Secondary Outcome Measures:
  • Change in 7 Meter Walk Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Time complete the 7 m Walk test after 6 months aerobic training - Time complete the 7 m Walk test at baseline

  • Change in the UPDRS Section I Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    =Score after 6 months training - baseline score Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.

  • Change in UPDRS Section II Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    =Score after 6 months training - baseline score Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.

  • Change in the UPDRS Section III Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    =Score after 6 months training - baseline score Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.

  • Change in the Total UPDRS Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    =Score after 6 months training - baseline score The total UPDRS score is calculated by adding Section I, Section II, and Section III scores (below). Higher scores are worse. The score ranges 0-176.

    Unified Parkinson's Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108.


  • Change in the MOCA Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    =Score after 6 months training - baseline score. MOCA=Montreal Cognitive Training Assessment Scores range 0-30, higher is better.

  • Change in Percent Increase Score (PIS) on Eriksen's Flanker Task [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    performance on the Eriksen's flanker task (see PMID: 24991037). Participants were asked to identify the orientation of a central arrow cue ('<' or '>'), which was flanked on both sides by two arrow cues that either pointed in the same direction (congruent: <<<<<) or a different direction (incongruent: >><>>). Using reaction times (RT) during congruent and incongruent trials, the PIS was calculated as =((RT_incongruent - RT_congruent) / RT_congruent) * 100. Higher PIS is worse.


Other Outcome Measures:
  • Change in Fatigue Severity Scale Score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    =Score after 6 months of training - baseline score. The Fatigue Severity Scale (FSS) is a self-administered unidimensional generic 9-item fatigue rating scale. These are rated on a seven-grade Likert scale of which only the respective ends are defined (''completely disagree''=1 to ''completely agree''=7). The total FSS score represents the mean score of each of the nine items, yielding a score range between 1 and 7, higher scores indicating a higher level of fatigue.

  • Change in Geriatric Depression Scale Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    =Score after 6 months training - score at baseline. The Geriatric Depression Scale (GDS)-short form is a 15 item yes/no questionnaire. The range is 0-15 and scores >5 suggest depression. Higher scores are worse.

  • Change in Parkinson's Disease Quality of Life Scale (PDQUALIF) Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    = PDQUALIF score after 6 months training - baseline score The PDQUALIF is a 32 item questionnaire resulting in 7 factors. . Subjects rate themselves between 1 (most favorable) and 5 (least favorable) on a Likert scale. Factor scores are standardized to100 and lower scores are better. The outcome measure is the average of these 7 factor scores.

  • Change in LEDD (Levodopa Equivalent Daily Dose) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    =amount after 6 months training - amount at baseline Total antiparkinsonian treatment daily dose expressed in levodopa equivalents per Tomlinson et al (PMID:21069833). Higher scores are worse.


Enrollment: 104
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: Continuous training
Aerobic walking using continuous heart rate training.
Behavioral: Continuous training
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.
Active Comparator: Interval training
Aerobic walking using interval heart rate training
Behavioral: Interval training
Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking [Wisloff et al. 2007].

  Show Detailed Description

  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
VA Office of Research and Development
University of Iowa
Investigators
Principal Investigator: Ergun Y. Uc, MD VA Medical Center, Iowa City
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00784563     History of Changes
Other Study ID Numbers: B6261-R 
Study First Received: October 30, 2008
Results First Received: January 16, 2015
Last Updated: August 25, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
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 February 09, 2016