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Exercise for People With Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
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

December 7, 2010
October 1, 2012
April 2003
April 2010   (final data collection date for primary outcome measure)
Functional Reach [ Time Frame: baseline, 4, 10, 16 months ] [ Designated as safety issue: No ]
Measure of balance
Not Provided
Complete list of historical versions of study NCT01257945 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Exercise for People With Parkinson's Disease
Exercise, Physical Function, and Parkinson's Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Parkinson's Disease
  • Behavioral: Aerobic Exercise
  • Behavioral: Flexibility and Function exercise program
  • Behavioral: Home exercise program
  • Experimental: Flexibility & Function
    Subjects take part in an exercise program based on flexibility and function.
    Intervention: Behavioral: Flexibility and Function exercise program
  • Experimental: Aerobic Exercise
    Subjects will take part in an aerobic exercise program
    Intervention: Behavioral: Aerobic Exercise
  • Home exercise
    Standard of care home exercise program
    Intervention: Behavioral: Home exercise program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
July 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01257945
02-0750, R01HD043770
Yes
University of Colorado, Denver
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Margaret Schenkman University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP