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Exercise for People With Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01257945
First received: December 7, 2010
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

This randomized, controlled exercise intervention with three groups compares two exercise approaches to standard of care. Supervised interventions are administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. Functional outcomes are measured at the completion of the supervised exercise (4 months) as well as 10 and 16 months.


Condition Intervention Phase
Parkinson's Disease
 Behavioral: Aerobic Exercise
Behavioral: Flexibility and Function exercise program
Behavioral: Home exercise program
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Exercise, Physical Function, and Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Functional Reach [ Time Frame: baseline, 4, 10, 16 months ] [ Designated as safety issue: No ]
    Measure of balance


Enrollment: 163
Study Start Date: April 2003
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flexibility & Function
Subjects take part in an exercise program based on flexibility and function.
 Behavioral: Flexibility and Function exercise program
Experimental: Aerobic Exercise
Subjects will take part in an aerobic exercise program
 Behavioral: Aerobic Exercise
Home exercise
Standard of care home exercise program
 Behavioral: Home exercise program

Detailed Description:

This randomized, controlled exercise intervention study compares physical therapy interventions for people in early and mid‐stages of Parkinson's disease. Two different approaches to exercise are compared to standard of care. The two exercise programs consist of supervised interventions, administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. The standard of care program consists of a home program in which participants exercise in a group setting once a month with an exercise trainer. Functional outcomes are measured at the completion of the supervised exercise at 4 months as well as 10 and 16 months. This study is the first long term exercise study for people with Parkinson's disease PD of which we are aware and is the most comprehensive examination of exercise for people with PD to date. Results of this study will provide definitive information regarding the best approach to exercise for people in early and mid stages of PD, both in terms of immediate 4 month and long term 16 month effects.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease
  • Hoehn & Yahr stages 1-3.5

Exclusion Criteria:

  • Cardiovascular contraindications to aerobic exercise
  • Reliance on walker or wheelchair
  • Psychiatric conditions
  • DBS or other surgeries
  • Any other conditions that would interfere with exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257945

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Margaret Schenkman University of Colorado, Denver
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01257945     History of Changes
Other Study ID Numbers: 02-0750, R01HD043770
Study First Received: December 7, 2010
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013