NCT01257945

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

7 years

First QC Date

December 7, 2010

Last Update Submit

October 1, 2012

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Functional Reach

    Measure of balance

    baseline, 4, 10, 16 months

Study Arms (3)

Flexibility & Function

EXPERIMENTAL

Subjects take part in an exercise program based on flexibility and function.

Behavioral: Flexibility and Function exercise program

Aerobic Exercise

EXPERIMENTAL

Subjects will take part in an aerobic exercise program

Behavioral: Aerobic Exercise

Home exercise

OTHER

Standard of care home exercise program

Behavioral: Home exercise program

Interventions

Aerobic ExerciseBEHAVIORAL
Aerobic Exercise
Flexibility and Function exercise programBEHAVIORAL
Flexibility & Function
Home exercise programBEHAVIORAL
Home exercise

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cardiovascular contraindications to aerobic exercise
  • Reliance on walker or wheelchair
  • Psychiatric conditions
  • DBS or other surgeries
  • Any other conditions that would interfere with exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (5)

  • 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.

    PMID: 19441128BACKGROUND

  • 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.

    PMID: 17940108RESULT

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

  • 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.

    PMID: 22822237DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

ExercisePliability

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMechanical PhenomenaPhysical Phenomena

Study Officials

  • Margaret Schenkman

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 10, 2010

Study Start

April 1, 2003

Primary Completion

April 1, 2010

Study Completion

July 1, 2010

Last Updated

October 2, 2012

Record last verified: 2012-10

Locations

US(1)