NCT01506479

Brief Summary

The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

December 16, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 13, 2017

Completed
Last Updated

October 13, 2017

Status Verified

September 1, 2017

Enrollment Period

4.5 years

First QC Date

December 16, 2011

Results QC Date

June 23, 2017

Last Update Submit

September 12, 2017

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseBasal Ganglia DiseaseCentral Nervous System DiseasesNervous System DiseasesMovement DisordersNeurodegenerative DiseasesBrain Diseases

Outcome Measures

Primary Outcomes (1)

  • Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise

    To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.

    9 to 26 weeks

Secondary Outcomes (1)

  • 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score

    Baseline and 6 months

Other Outcomes (1)

  • Number of Days of Exercise Per Week

    9 to 26 weeks

Study Arms (3)

Control Group

SHAM COMPARATOR

Wait listed to moderate or vigorous exercise after 6 months of no exercise.

Behavioral: No Intervention

Vigorous Exercise

EXPERIMENTAL

Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Behavioral: Vigorous Exercise

Moderate Exercise

EXPERIMENTAL

Endurance exercise at 60-65% HR max, 4x/wk for 6 months.

Behavioral: Moderate Exercise

Interventions

Moderate ExerciseBEHAVIORAL

Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.

Moderate Exercise
Vigorous ExerciseBEHAVIORAL

Endurance exercise at 80-85% HR max, 4x/wk for 6 months.

Vigorous Exercise
No InterventionBEHAVIORAL

No-exercise control (i.e., usual care);

Control Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of primary Parkinson's disease
  • In a Hoehn and Yahr stage less than stage III
  • Disease duration is less than 5 years
  • Not likely to require dopaminergic therapy within 6 months

You may not qualify if:

  • Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
  • Duration of previous use of medications for PD that exceeds 90 days
  • Expected to require dopaminergic therapy in the next 6 months
  • Poorly controlled or unstable cardiovascular disease
  • Uncontrolled hypertension
  • Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
  • Mild cognitive impairment (Montreal Cognitive Assessment score\<26/30)
  • Depression that precludes ability to exercise (Beck depression score\>13)
  • Disorders that interfere with ability to perform endurance exercises
  • Regular participation in vigorous endurance exercise
  • Evidence of serious arrhythmias or ischemic heart disease
  • Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • 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

  • Hall DA, Moore C, Comella C; SPARX Study Group. Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial. Trials. 2018 Nov 14;19(1):630. doi: 10.1186/s13063-018-2958-z.

    PMID: 30428907DERIVED

  • Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.

    PMID: 29228079DERIVED

  • Moore CG, Schenkman M, Kohrt WM, Delitto A, Hall DA, Corcos D. Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Contemp Clin Trials. 2013 Sep;36(1):90-8. doi: 10.1016/j.cct.2013.06.002. Epub 2013 Jun 14.

    PMID: 23770108DERIVED

MeSH Terms

Conditions

Parkinson DiseaseBasal Ganglia DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersNeurodegenerative DiseasesBrain Diseases

Condition Hierarchy (Ancestors)

Parkinsonian DisordersSynucleinopathies

Results Point of Contact

Title
Dr. Charity G. Moore
Organization
University of Pittsburgh
cgp22@pitt.edu
412-383-6630

Study Officials

  • Margaret Schenkman, PT, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Daniel Corcos, PhD

    University of Illinois at Chicago

    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
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

January 10, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 13, 2017

Results First Posted

October 13, 2017

Record last verified: 2017-09

Locations

US(3)