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Completed

NCT Number: NCT01257945

Exercise for People With 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

Flexibility and Function exercise program

Behavioral

Home Exercise Program

Behavioral

Primary outcomes

  1. Functional Reach

    Time frame: baseline, 4, 10, 16 months

    Measure of balance

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Exercise, Physical Function, and Parkinson's Disease

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Dec 10, 2010
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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