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Effect of Body Suspension and Tilting Exercises in Parkinson's Disease

24 november 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazilië
        • Serviço de Neurologia do Hospital São Lucas da PUCRS

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar tot 85 jaar (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Intervention group (Body body suspension and tilting exercises)
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.
Andere namen:
  • Chordata body suspension and tilting
Sham-vergelijker: Control group
Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks.
Ander: Control group (global muscle stretching)
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.
Andere namen:
  • Controle

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Timed Up and Go Test
Tijdsspanne: At 8th week (in the end of exercise protocol).
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.
At 8th week (in the end of exercise protocol).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Berg Balance Test
Tijdsspanne: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Functional Reach Test
Tijdsspanne: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Baropodometry (Stabilometric parameters)
Tijdsspanne: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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).
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Unified Parkinson Disease Rating Scale (UPDRS)
Tijdsspanne: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Parkinson's Disease Questionnaire (PDQ-39)
Tijdsspanne: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
The Parkinson's Disease Questionnaire (PDQ-39) is primarily used in clinical trials of therapeutics intended to benefit individuals with Parkinson's disease.
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Timed Up and Go Test
Tijdsspanne: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hoehn and Yahr Staging of Parkinson's Disease
Tijdsspanne: This test will be performed just at baseline (to classify the subjects).
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
This test will be performed just at baseline (to classify the subjects).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Onderzoekers

  • Studie stoel: Irênio G da Silva Filho, PhD, Pontificia Universidade Católica do Rio Grande do Sul
  • Studie stoel: Carlos Roberto M Rieder, PhD, Hospital de Clínicas de Porto Alegre
  • Studie directeur: Régis G Mestriner, PhD, Pontificia Universidade Católica do Rio Grande do Sul
  • Hoofdonderzoeker: Charlene B de Oliveira, MSc, Pontificia Universidade Católica do Rio Grande do Sul

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2015

Primaire voltooiing (Werkelijk)

1 mei 2016

Studie voltooiing (Werkelijk)

1 mei 2016

Studieregistratiedata

Eerst ingediend

28 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2016

Eerst geplaatst (Schatting)

5 mei 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

28 november 2016

Laatste update ingediend die voldeed aan QC-criteria

24 november 2016

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 555

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Onbeslist

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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