Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
2016年11月24日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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).
研究の種類
介入
入学 (実際)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル
- Serviço de Neurologia do Hospital São Lucas da PUCRS
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年～85年 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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偽コンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Timed Up and Go Test
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Berg Balance Test
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hoehn and Yahr Staging of Parkinson's Disease
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Irênio G da Silva Filho, PhD、Pontificia Universidade Católica do Rio Grande do Sul
- スタディチェア：Carlos Roberto M Rieder, PhD、Hospital de Clinicas de Porto Alegre
- スタディディレクター：Régis G Mestriner, PhD、Pontificia Universidade Católica do Rio Grande do Sul
- 主任研究者：Charlene B de Oliveira, MSc、Pontificia Universidade Católica do Rio Grande do Sul
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年9月1日
一次修了 (実際)
2016年5月1日
研究の完了 (実際)
2016年5月1日
試験登録日
最初に提出
2016年4月28日
QC基準を満たした最初の提出物
2016年5月4日
最初の投稿 (見積もり)
2016年5月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11月28日
QC基準を満たした最後の更新が送信されました
2016年11月24日
最終確認日
2016年11月1日
詳しくは
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