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The Effect of Exercise on Individuals With Parkinson's Disease

maanantai 16. helmikuuta 2015 päivittänyt: Daniel Corcos, University of Illinois at Chicago
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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

51

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60612
        • Physical Therapy Department at the University of Illinois at Chicago

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

50 vuotta - 67 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: Progressive resistance training
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.
Käyttäytyminen: Progressive resistance training
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.
Active Comparator: Modified Fitness Counts
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.
Käyttäytyminen: Modified Fitness Counts
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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Off Medication UPDRS Part III, Motor Subscale Score
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
On Medication UPDRS-III
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
L-dopa equivalent-mg/Day
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Elbow Flexion Strength
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is the MVC for elbow flexion
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Ankle Plantar Flexion Strength
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is a measure of the MVC for ankle plantar flexion strength
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Elbow Extension Strength
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is a measure of the MVC for elbow extension
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Ankle Dorsiflexion Strength
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is a measure of the MVC for ankle dorsiflexion
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The Integral of the First Agonist Burst
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Magnitude of the First 30 ms of the Agonist Burst
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The integral of the first 30 msec of the agonist EMG.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Magnitude of the Antagonist Burst
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Magnitude of the Agonist Burst
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Magnitude of the agonist burst reflects the amount of agonist activation during movement.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Duration of First Agonist Burst
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Number of Agonist Bursts
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is the number of agonist bursts prior to peak velocity.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Co-contraction During Limb Acceleration
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
the amount of agonist and antagonist activity present during limb acceleration.
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Qant
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Time to Peak Velocity
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Time of the onset of the movement to peak velocity.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Peak Movement Velocity
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is how fast an individual can perform a 72 degree elbow flexion movement
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Relaxation Time
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Rise Time
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Spatiotemporal Gait Analysis
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Distance Walked in 6 Minutes
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is how far an individual can walk in 6 minutes
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Modified Physical Performance Test
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is an overall measure of physical fuction
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Time on the Timed up and go Test
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Berg Balance Scale Score
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is a overall measure of balance
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Functional Reach
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The distance one can reach forward without taking a step.
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Cognitive Function - Stroop Test
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
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.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Cognitive Function - Brief Test of Attention
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is a cognitive test of an individuals ability to remember number. It is a test of working memory.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Cognitive Function - Digit Span Forward/Backward
Aikaikkuna: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This tests a persons ability to remember that were read to them both forward and then backwards.
obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Parkinson 's Disease Quality of Life
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Epworth Sleepiness Scale
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Beck's Depression Inventory
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
50 ft Walk Time
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Time it takes to walk 50 feet
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
50 Foot Walk Speed
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The speed that aerson walks over 50 feet
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
5 Time Sit to Stand
Aikaikkuna: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
The time it takes to stand up and sit down five times
Obtained during initial evaluation & then every 6 six months to end of 2-yr training period

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of Illinois at Chicago

Yhteistyökumppanit

National Institute of Neurological Disorders and Stroke (NINDS)

Tutkijat

  • Päätutkija: Daniel Corcos, Ph.D., Northwestern University

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Maanantai 1. lokakuuta 2007

Ensisijainen valmistuminen (Todellinen)

Perjantai 1. heinäkuuta 2011

Opintojen valmistuminen (Todellinen)

Lauantai 1. lokakuuta 2011

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 26. joulukuuta 2007

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 10. tammikuuta 2008

Ensimmäinen Lähetetty (Arvio)

Perjantai 11. tammikuuta 2008

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Torstai 5. maaliskuuta 2015

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 16. helmikuuta 2015

Viimeksi vahvistettu

Sunnuntai 1. helmikuuta 2015

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • R01NS028127 (Yhdysvaltain NIH-apuraha/sopimus)
  • 5R01NS028127-16 (Yhdysvaltain NIH-apuraha/sopimus)

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Progressive resistance training

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