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The Effect of Exercise on Individuals With Parkinson's Disease

2015. február 16. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

51

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

50 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Aktív összehasonlító: 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.
Viselkedési: 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.
Aktív összehasonlító: 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.
Viselkedési: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Off Medication UPDRS Part III, Motor Subscale Score
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
On Medication UPDRS-III
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University of Illinois at Chicago

Együttműködők

National Institute of Neurological Disorders and Stroke (NINDS)

Nyomozók

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

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2007. október 1.

Elsődleges befejezés (Tényleges)

2011. július 1.

A tanulmány befejezése (Tényleges)

2011. október 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2007. december 26.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2008. január 10.

Első közzététel (Becslés)

2008. január 11.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2015. március 5.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2015. február 16.

Utolsó ellenőrzés

2015. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • R01NS028127 (Az Egyesült Államok NIH támogatása/szerződése)
  • 5R01NS028127-16 (Az Egyesült Államok NIH támogatása/szerződése)

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Progressive resistance training

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