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The Effect of Exercise on Individuals With Parkinson's Disease

16 lutego 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

51

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat do 67 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny 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.
Behawioralne: 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.
Aktywny 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Off Medication UPDRS Part III, Motor Subscale Score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
On Medication UPDRS-III
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Illinois at Chicago

Współpracownicy

National Institute of Neurological Disorders and Stroke (NINDS)

Śledczy

  • Główny śledczy: Daniel Corcos, Ph.D., Northwestern University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2007

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2011

Ukończenie studiów (Rzeczywisty)

1 października 2011

Daty rejestracji na studia

Pierwszy przesłany

26 grudnia 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 stycznia 2008

Pierwszy wysłany (Oszacować)

11 stycznia 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

5 marca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 lutego 2015

Ostatnia weryfikacja

1 lutego 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • R01NS028127 (Grant/umowa NIH USA)
  • 5R01NS028127-16 (Grant/umowa NIH USA)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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