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The Effect of Exercise on Individuals With Parkinson's Disease

16 février 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

51

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
        • Physical Therapy Department at the University of Illinois at Chicago

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans à 67 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Comportemental: 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.
Comparateur actif: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Off Medication UPDRS Part III, Motor Subscale Score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
On Medication UPDRS-III
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Illinois at Chicago

Collaborateurs

National Institute of Neurological Disorders and Stroke (NINDS)

Les enquêteurs

  • Chercheur principal: Daniel Corcos, Ph.D., Northwestern University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2007

Achèvement primaire (Réel)

1 juillet 2011

Achèvement de l'étude (Réel)

1 octobre 2011

Dates d'inscription aux études

Première soumission

26 décembre 2007

Première soumission répondant aux critères de contrôle qualité

10 janvier 2008

Première publication (Estimation)

11 janvier 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

5 mars 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 février 2015

Dernière vérification

1 février 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R01NS028127 (Subvention/contrat des NIH des États-Unis)
  • 5R01NS028127-16 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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