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NCT Number: NCT01506479

Study in Parkinson's Disease of Exercise

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver, Aurora, Colorado, United States

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About this study

The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

moderate exercise

Behavioral

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

Vigorous exercise

Behavioral

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

No intervention

Behavioral

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

Primary outcomes

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

    Time frame: 9 to 26 weeks

    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.

Secondary outcomes

  1. 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score

    Time frame: Baseline and 6 months

    Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.

Other outcomes

  1. Number of Days of Exercise Per Week

    Time frame: 9 to 26 weeks

    The number of days the participant exercised per week

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Northwestern University
  • Rush University Medical Center
  • University of Illinois at Chicago
  • University of Pittsburgh

Registry information

Official study title

Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease

Acronym: SPARX

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2012
Registry last updated
Oct 13, 2017

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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