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

24. november 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 85 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Andre navne:
  • Chordata body suspension and tilting
Sham-komparator: Control group
Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks.
Andet: 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.
Andre navne:
  • Styring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Timed Up and Go Test
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Berg Balance Test
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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).

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hoehn and Yahr Staging of Parkinson's Disease
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Efterforskere

  • Studiestol: Irênio G da Silva Filho, PhD, Pontificia Universidade Católica do Rio Grande do Sul
  • Studiestol: Carlos Roberto M Rieder, PhD, Hospital de Clinicas de Porto Alegre
  • Studieleder: Régis G Mestriner, PhD, Pontificia Universidade Católica do Rio Grande do Sul
  • Ledende efterforsker: Charlene B de Oliveira, MSc, Pontificia Universidade Católica do Rio Grande do Sul

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

28. april 2016

Først indsendt, der opfyldte QC-kriterier

4. maj 2016

Først opslået (Skøn)

5. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 555

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