Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
2016년 11월 24일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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).
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, 브라질
- Serviço de Neurologia do Hospital São Lucas da PUCRS
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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가짜 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Timed Up and Go Test
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Berg Balance Test
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hoehn and Yahr Staging of Parkinson's Disease
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Irênio G da Silva Filho, PhD, Pontificia Universidade Católica do Rio Grande do Sul
- 연구 의자: Carlos Roberto M Rieder, PhD, Hospital de Clínicas de Porto Alegre
- 연구 책임자: Régis G Mestriner, PhD, Pontificia Universidade Católica do Rio Grande do Sul
- 수석 연구원: Charlene B de Oliveira, MSc, Pontificia Universidade Católica do Rio Grande do Sul
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 9월 1일
기본 완료 (실제)
2016년 5월 1일
연구 완료 (실제)
2016년 5월 1일
연구 등록 날짜
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2016년 4월 28일
QC 기준을 충족하는 최초 제출
2016년 5월 4일
처음 게시됨 (추정)
2016년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 11월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 11월 24일
마지막으로 확인됨
2016년 11월 1일
추가 정보
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