Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
24 novembre 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil
- Serviço de Neurologia do Hospital São Lucas da PUCRS
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans à 85 ans (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
Autres noms:
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Comparateur factice: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Timed Up and Go Test
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Berg Balance Test
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.
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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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hoehn and Yahr Staging of Parkinson's Disease
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: Irênio G da Silva Filho, PhD, Pontificia Universidade Católica do Rio Grande do Sul
- Chaise d'étude: Carlos Roberto M Rieder, PhD, Hospital de Clinicas de Porto Alegre
- Directeur d'études: Régis G Mestriner, PhD, Pontificia Universidade Católica do Rio Grande do Sul
- Chercheur principal: Charlene B de Oliveira, MSc, Pontificia Universidade Católica do Rio Grande do Sul
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2015
Achèvement primaire (Réel)
1 mai 2016
Achèvement de l'étude (Réel)
1 mai 2016
Dates d'inscription aux études
Première soumission
28 avril 2016
Première soumission répondant aux critères de contrôle qualité
4 mai 2016
Première publication (Estimation)
5 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
28 novembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 novembre 2016
Dernière vérification
1 novembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 555
Plan pour les données individuelles des participants (IPD)
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Indécis
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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