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The Effect of Exercise on Individuals With Parkinson's Disease

16. Februar 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

51

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre bis 67 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verhalten: 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.
Aktiver Komparator: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Off Medication UPDRS Part III, Motor Subscale Score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
On Medication UPDRS-III
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Illinois at Chicago

Mitarbeiter

National Institute of Neurological Disorders and Stroke (NINDS)

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2007

Primärer Abschluss (Tatsächlich)

1. Juli 2011

Studienabschluss (Tatsächlich)

1. Oktober 2011

Studienanmeldedaten

Zuerst eingereicht

26. Dezember 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Januar 2008

Zuerst gepostet (Schätzen)

11. Januar 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

5. März 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Februar 2015

Zuletzt verifiziert

1. Februar 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R01NS028127 (US NIH Stipendium/Vertrag)
  • 5R01NS028127-16 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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