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CompletedNCT01257945Updated Oct 2, 2012

Exercise for People With Parkinson's Disease

A Phase 2 interventional study of Aerobic Exercise and Flexibility and Function exercise program in Parkinson's Disease, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2012-10-02.

Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
35 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 163 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
163 participants (actual)

Study arms

  • 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

  • Other
    Home exercise

    Standard of care home exercise program

    Behavioral: Home exercise program

Interventions

  • BehavioralAerobic Exercise
  • BehavioralFlexibility and Function exercise program
  • BehavioralHome exercise program
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What researchers measure

Primary outcomes

  1. Functional Reach

    Measure of balance

    Time frame: baseline, 4, 10, 16 months

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Study locations

1 site
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
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References and documents

Publications

  • Christiansen CL, Schenkman ML, McFann K, Wolfe P, Kohrt WM. Walking economy in people with Parkinson's disease. Mov Disord. 2009 Jul 30;24(10):1481-7. doi: 10.1002/mds.22621. PubMed 19441128 ↗
  • Schenkman M, Hall D, Kumar R, Kohrt WM. Endurance exercise training to improve economy of movement of people with Parkinson disease: three case reports. Phys Ther. 2008 Jan;88(1):63-76. doi: 10.2522/ptj.20060351. Epub 2007 Oct 16. PubMed 17940108 ↗
  • Schenkman M, Hall DA, Baron AE, Schwartz RS, Mettler P, Kohrt WM. Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Phys Ther. 2012 Nov;92(11):1395-410. doi: 10.2522/ptj.20110472. Epub 2012 Jul 19. PubMed 22822237 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01257945
Lead sponsor
University of Colorado, Denver
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Dec 10, 2010
Start date
Apr 2003
Primary completion
Apr 2010
Completion
Jul 2010
Last update
Oct 2, 2012

Study contacts

Margaret Schenkman
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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