NCT00591344

Brief Summary

The goal of this trial is to compare the effect of two different exercise programs on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease to determine which program is most beneficial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

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

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 9, 2015

Completed
Last Updated

March 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3.8 years

First QC Date

December 26, 2007

Results QC Date

December 23, 2014

Last Update Submit

February 16, 2015

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseexercise

Outcome Measures

Primary Outcomes (1)

  • Off Medication UPDRS Part III, Motor Subscale Score

    UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.

    obtained during initial evaluation & then every 6 six months to end of 2-yr training period

Secondary Outcomes (34)

  • On Medication UPDRS-III

    obtained during initial evaluation & then every 6 six months to end of 2-yr training period

  • L-dopa equivalent-mg/Day

    obtained during initial evaluation & then every 6 six months to end of 2-yr training period

  • Elbow Flexion Strength

    obtained during initial evaluation & then every 6 six months to end of 2-yr training period

  • Ankle Plantar Flexion Strength

    obtained during initial evaluation & then every 6 six months to end of 2-yr training period

  • Elbow Extension Strength

    obtained during initial evaluation & then every 6 six months to end of 2-yr training period

  • +29 more secondary outcomes

Study Arms (2)

Progressive resistance training

ACTIVE COMPARATOR

Subjects will perform between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.

Behavioral: Progressive resistance training

Modified Fitness Counts

ACTIVE COMPARATOR

Subjects will perform between 60 and 90 minutes of modified Fitness Counts two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.

Behavioral: Modified Fitness Counts

Interventions

Progressive resistance trainingBEHAVIORAL

Exercise twice a week for 2 years doing either progressive resistance training. The The PRE program consisted of 11 strengthening exercises: chest press, latissimus pull downs, reverse flys, double leg press, hip extension, shoulder press, biceps curl, rotary calf (ankle plantar flexion), triceps extension, seated quadriceps extension and back extension.

Progressive resistance training
Modified Fitness CountsBEHAVIORAL

The modified Fitness Counts program was taken from Chapters 2 and 3 of the Parkinson's disease: Fitness Counts booklet and focused on non-progressive stretching, strengthening and balance exercises.

Modified Fitness Counts

Eligibility Criteria

Age50 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of PD
  • Up to the age of 67
  • on at least 1 DA drug, may be on several PD medications
  • able to walk for six minutes (may take rest breaks)
  • able to come off their PD medication for testing (12 hour overnight withdrawal of antiparkinsonian medications)
  • able to stay on stable PD medications for at least 6 months
  • live within a 30 mile radius of Chicago
  • Hoehn and Yahr Score: II - III while in the "Off" PD medication state

You may not qualify if:

  • history of any other neurological disorder as determined by medical history and neurological exam
  • history of a known injury, disease, or other disorder that might interfere with motor function in the proposed experiments
  • a score less than 23 on the Mini-Mental State Examination
  • currently involved in an active, ongoing formal exercise program deep brain stimulation surgery
  • known cardiac problem or significant hypertension
  • depression that may interfere with regular exercise
  • hallucinations or being treated for hallucinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Department at the University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • 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

  • David FJ, Robichaud JA, Leurgans SE, Poon C, Kohrt WM, Goldman JG, Comella CL, Vaillancourt DE, Corcos DM. Exercise improves cognition in Parkinson's disease: The PRET-PD randomized, clinical trial. Mov Disord. 2015 Oct;30(12):1657-63. doi: 10.1002/mds.26291. Epub 2015 Jul 6.

    PMID: 26148003DERIVED

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Daniel Corcos, PhD
Organization
Northwestern University
daniel.corcos@northwestern.edu
708-214-5454

Study Officials

  • Daniel Corcos, Ph.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

October 1, 2007

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

March 5, 2015

Results First Posted

February 9, 2015

Record last verified: 2015-02

Locations

US(1)