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

24 novembre 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 65 anni a 85 anni (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Altri nomi:
  • Chordata body suspension and tilting
Comparatore fittizio: Control group
Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks.
Altro: 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.
Altri nomi:
  • Controllo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Timed Up and Go Test
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Berg Balance Test
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Hoehn and Yahr Staging of Parkinson's Disease
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Investigatori

  • Cattedra di studio: Irênio G da Silva Filho, PhD, Pontificia Universidade Católica do Rio Grande do Sul
  • Cattedra di studio: Carlos Roberto M Rieder, PhD, Hospital de Clinicas de Porto Alegre
  • Direttore dello studio: Régis G Mestriner, PhD, Pontificia Universidade Católica do Rio Grande do Sul
  • Investigatore principale: Charlene B de Oliveira, MSc, Pontificia Universidade Católica do Rio Grande do Sul

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2015

Completamento primario (Effettivo)

1 maggio 2016

Completamento dello studio (Effettivo)

1 maggio 2016

Date di iscrizione allo studio

Primo inviato

28 aprile 2016

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2016

Primo Inserito (Stima)

5 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 novembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 555

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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