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Parkinson's DiseaseNCT00591344

The Effect of Exercise on Individuals With Parkinson's Disease

A study testing Progressive resistance training and Modified Fitness Counts in people with Parkinson's Disease, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 67 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Progressive resistance training and Modified Fitness Counts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
Oct 2007to Oct 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Physical Therapy Department at the University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

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.

Read the detailed description

Parkinson's disease (PD) negatively affects the quality of life for a million individuals in the United States. While medication and surgery are the most effective treatments for PD, physicians and people with PD often delay using these treatments because of their considerable adverse side effects. Until a cure for PD is discovered, there is a compelling need to develop interventions that provide relief of symptoms without causing negative side effects.

Recent research suggests that exercise may provide symptom relief in some characteristics of PD. While various exercise interventions appear to effectively improve motor, functional, and quality-of-life issues, the research is mixed regarding the nature, extent and duration of these improvements. Understanding how multiple characteristics of PD change and whether they can be modified by different exercise programs is essential to determining if an exercise program is clinically effective for PD.

This study is designed to compare the initial (six months), and then long-term (2 years) effect that 2 different exercise programs (progressive resistance program or flexibility program) have on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease. The goal is to determine which program is most beneficial. Results from this study will be used to determine which exercise program produces the most beneficial effects on neuro-physiological, motor, functional and quality-of-life measures.

NOTE: Recruitment for Parkinson's disease participants is now closed.

Being tested
Progressive resistance training, Modified Fitness Counts
Keywords
Parkinson's disease, exercise
Medical subject headings
Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive resistance trainingBehavioural

    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.

  • Modified Fitness CountsBehavioural

    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.

Study groups in NCT00591344
Study groupRoleWhat they receive
Progressive resistance trainingActive comparatorSubjects 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.
Receives: Behavioral: Progressive resistance training
Modified Fitness CountsActive comparatorSubjects 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.
Receives: Behavioral: Modified Fitness Counts

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (34)
  1. On Medication UPDRS-III

    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 the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.

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

  2. L-dopa equivalent-mg/Day

    This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.

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

  3. Elbow Flexion Strength

    This is the MVC for elbow flexion

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

  4. Ankle Plantar Flexion Strength

    This is a measure of the MVC for ankle plantar flexion strength

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

  5. Elbow Extension Strength

    This is a measure of the MVC for elbow extension

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

  6. Ankle Dorsiflexion Strength

    This is a measure of the MVC for ankle dorsiflexion

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

  7. Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions

    This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.

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

  8. The Integral of the First Agonist Burst

    The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity

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

  9. Magnitude of the First 30 ms of the Agonist Burst

    The integral of the first 30 msec of the agonist EMG.

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

  10. Magnitude of the Antagonist Burst

    the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.

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

  11. Magnitude of the Agonist Burst

    Magnitude of the agonist burst reflects the amount of agonist activation during movement.

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

  12. Duration of First Agonist Burst

    Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity

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

  13. Number of Agonist Bursts

    This is the number of agonist bursts prior to peak velocity.

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

  14. Co-contraction During Limb Acceleration

    the amount of agonist and antagonist activity present during limb acceleration.

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

  15. Qant

    The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement

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

  16. Time to Peak Velocity

    Time of the onset of the movement to peak velocity.

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

  17. Peak Movement Velocity

    This is how fast an individual can perform a 72 degree elbow flexion movement

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

  18. Relaxation Time

    Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC

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

  19. Rise Time

    This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.

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

  20. Spatiotemporal Gait Analysis

    Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.

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

  21. Distance Walked in 6 Minutes

    This is how far an individual can walk in 6 minutes

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

  22. Modified Physical Performance Test

    This is an overall measure of physical fuction

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

  23. Time on the Timed up and go Test

    This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.

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

  24. Berg Balance Scale Score

    This is a overall measure of balance

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

  25. Functional Reach

    The distance one can reach forward without taking a step.

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

  26. Cognitive Function - Stroop Test

    This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.

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

  27. Cognitive Function - Brief Test of Attention

    This is a cognitive test of an individuals ability to remember number. It is a test of working memory.

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

  28. Cognitive Function - Digit Span Forward/Backward

    This tests a persons ability to remember that were read to them both forward and then backwards.

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

  29. Parkinson 's Disease Quality of Life

    PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.

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

  30. Epworth Sleepiness Scale

    The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.

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

  31. Beck's Depression Inventory

    This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.

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

  32. 50 ft Walk Time

    Time it takes to walk 50 feet

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

  33. 50 Foot Walk Speed

    The speed that aerson walks over 50 feet

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

  34. 5 Time Sit to Stand

    The time it takes to stand up and sit down five times

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00591344
Sponsor's protocol ID
R01NS028127
Other IDs
5R01NS028127-16
Status last verified
Feb 2015
First submitted
26 Dec 2007
Last updated
5 Mar 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 38588457
  • 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.

    PubMed 36602886
  • 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.

    PubMed 26148003

Questions about this trial

What is this clinical trial studying?

A study testing Progressive resistance training and Modified Fitness Counts in people with Parkinson's Disease, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Off Medication UPDRS Part III, Motor Subscale Score (time frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00591344, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.

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