Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
24 listopada 2016 zaktualizowane przez: Pontificia Universidade Católica do Rio Grande do Sul
This study evaluates the effect of body suspension and tilting exercises (performed in Chordata apparatus) on the balance and mobility of subjects with Parkinson disease.
Half of patients will perform the exercise protocol while the other half will receive passive muscle stretching and maintain the usual routine.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Body suspension and tilting exercises performed in the Chordata equipment might be an effective option to improve trunk muscles activation and to facilitate functional balance and mobility control in Parkinson's disease (PD).
To evaluate this hypothesis, subjects will be randomized into control group or intervention group.
Intervention group will receive 30-minute session of body suspension and tilting exercises on the Chordata equipment (PI: 0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks, while the control group will receive passive muscle stretching and maintained their usual routine during the same period.
Both groups will be assessed at baseline and immediately after the intervention protocol.
Finally, a follow-up evaluation will be performed 8 weeks after the protocol ending (to verify possible long-lasting effects of this exercise protocol).
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
40
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazylia
- Serviço de Neurologia do Hospital São Lucas da PUCRS
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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
65 lat do 85 lat (Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Subjects able to go to training or assessment places;
- Subjects that are agreement with the study protocol and sign the ;
- Subjects in stage I, II or III of Parkinson disease according to the Hoehn and Yahr scale.
Exclusion Criteria:
- Subjects do not keep their usual routine (apart of the research protocol);
- Subjects with physical or functional limitations that prevent the assessment test battery;
- Subjects with heart or lung diseases that prevent the exercise performance;
- Subjects with cancer;
- Subjects with major visual deficits;
- Subjects with recurrent vertigo;
- Subjects with uncontrolled systemic blood pressure.
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 podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Intervention group
Subjects submitted to a 30-minute session of suspension and tilting exercises on the Chordata equipment (PI: 0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks.
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The body suspension and tilting exercise program (Chordata Method) involved suspending the body in the apparatus while performing tilting exercises.
The Chordata apparatus consists of a steel structure with special springs and a harness specifically manufactured for practicing the Chordata Method.
During the training sessions, the prescribed exercises emphasize the repetition of movements designed to promote different types of muscle contractions (concentric, eccentric, static) performed in different body positions and joint angles.
Thus, when using the method, patients experience maximal functional performance beyond to the body mass centre, activating trunk antagonist muscles and motor memory evocation.
Each session lasts 30 minutes.
Inne nazwy:
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Pozorny komparator: Control group
Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks.
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Subjects receiving submitted a global muscle stretching session twice a week for eight weeks.
During this period.
All participants are requested to don't engage in any additional type of exercise program or physical activity throughout the study period.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Timed Up and Go Test
Ramy czasowe: At 8th week (in the end of exercise protocol).
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Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down.
The person wears regular footwear and customary walking aid.
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At 8th week (in the end of exercise protocol).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Berg Balance Test
Ramy czasowe: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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The Berg Balance Scale (BBS) is a widely used clinical test of a person's static and dynamic balance abilities.
For functional balance tests, the BBS is generally considered to be the gold standard.
The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot.
The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
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At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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Functional Reach Test
Ramy czasowe: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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The Functional Reach test can be administered while the patient is standing.
The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist.
The assessor records the starting position at the 3rd metacarpal head on the yardstick.
Instruct the patient to "Reach as far as you can forward without taking a step."
The location of the 3rd metacarpal is recorded in centimetre (cm).
Scores are determined by assessing the difference between the start and end position is the reach distance.
Three trials are done and the average of the last two is noted.
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At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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Baropodometry (Stabilometric parameters)
Ramy czasowe: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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In the test protocol adopted data uptake of the examination will be assessed walking on the pressure platform (dynamic measure) and stopped on the pressure platform with opened eyes (static measure).
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At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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Unified Parkinson Disease Rating Scale (UPDRS)
Ramy czasowe: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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The UPDRS is a rating tool to follow the longitudinal course of Parkinson's Disease.
It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections.
These are evaluated by interview.
Some sections require multiple grades assigned to each extremity.
A total of 199 points are possible.
199 represents the worst (total) disability), 0--no disability.
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At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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Parkinson's Disease Questionnaire (PDQ-39)
Ramy czasowe: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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The Parkinson's Disease Questionnaire (PDQ-39) is primarily used in clinical trials of therapeutics intended to benefit individuals with Parkinson's disease.
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At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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Timed Up and Go Test
Ramy czasowe: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down.
The person wears regular footwear and customary walking aid.
The investigators will measure the "change" at different time frames.
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At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Hoehn and Yahr Staging of Parkinson's Disease
Ramy czasowe: This test will be performed just at baseline (to classify the subjects).
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The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
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This test will be performed just at baseline (to classify the subjects).
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Krzesło do nauki: Irênio G da Silva Filho, PhD, Pontificia Universidade Católica do Rio Grande do Sul
- Krzesło do nauki: Carlos Roberto M Rieder, PhD, Hospital de Clínicas de Porto Alegre
- Dyrektor Studium: Régis G Mestriner, PhD, Pontificia Universidade Católica do Rio Grande do Sul
- Główny śledczy: Charlene B de Oliveira, MSc, Pontificia Universidade Católica do Rio Grande do Sul
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 września 2015
Zakończenie podstawowe (Rzeczywisty)
1 maja 2016
Ukończenie studiów (Rzeczywisty)
1 maja 2016
Daty rejestracji na studia
Pierwszy przesłany
28 kwietnia 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 maja 2016
Pierwszy wysłany (Oszacować)
5 maja 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
28 listopada 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 listopada 2016
Ostatnia weryfikacja
1 listopada 2016
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 555
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Niezdecydowany
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
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