Golf Instruction Versus Tai Chi for People With Parkinson's Disease
2020年9月2日 更新者：Anne-Marie Alexandra Wills, MD、Massachusetts General Hospital
Feasibility and Tolerability of Group Golf Instruction Versus Tai Chi for Patients With Moderate to Advanced Parkinson's Disease
The purpose of this study is to determine the feasibility and tolerability of golf instruction for participants with moderate to advanced Parkinson's disease (PD).
Other forms of exercise have been shown to be beneficial for PD.
Golf is a low impact sport that utilizes balance and strength.
Currently, there are no data looking at the effects of golf on PD.
This pilot study aims to test the effects of golf in the PD patient population, particularly its effect on balance.
In this study, we will be comparing group golf instruction to group Tai Chi lessons (the gold standard balance exercise for patients with PD).
調査の概要
詳細な説明
Approximately, 40-50 participants with Parkinson's Disease (H&Y stage 2 to 3) will be enrolled in this study.
Participants who provide informed consent will be randomized 1:1 to either group golf instruction or group Tai Chi classes.
Participants will be evaluated before and after the intervention with a battery of cognitive, motor and balance assessments including the UPDRS, the Mini-BESTest of balance, and timed up and go tests.
They will participate in classes twice weekly for 10 weeks which will be provided free of charge.
At the end of the intervention period they will repeat the assessments.
The primary outcomes of the study are feasibility and tolerability.
The key secondary objectives are to measure the efficacy of golf instruction on measures of balance, risk of falls.
研究の種類
介入
入学 (実際)
35
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
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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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
18年歳以上 (大人、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:
- Adult participants with a diagnosis of Parkinson's disease by a Movement Disorders specialist, H&Y stage II-III in the "On" state treated with Parkinson's disease medications
- Participants must be capable of providing informed consent and complying with trial procedures including transportation to and from classes.
- Participants must be willing and able to participate in group exercise classes.
- Participants who are engaged in physical therapy or other exercise programs must be at a stable regimen for 60 days prior to the start of the study and must be willing to maintain their current regimen for the duration of the study.
Exclusion Criteria:
- Clinical evidence of unstable medical or psychiatric illness which would prevent them from engaging in exercise
- Participants who are already active golfers or currently active in Tai Chi would be excluded.
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：Golf
Group golf lessons will be led by professional golf instructors.
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Subjects will participate in two weekly hour-long golf classes.
Classes will be led by professional golf instructors that will work with individuals to teach participants how to play golf.
This will include stretching, individual coaching, and working with participants to maximize their golf swing.
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アクティブコンパレータ：Tai Chi
Group Tai Chi classes led by a certified Tai Chi instructor.
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Tai Chi is an ancient martial art that uses meditative movement to improve strength, flexibility, and balance.
Subjects will participate in two weekly hour-long Tai Chi classes.The class will be led by a certified Tai Chi instructor and consist of approximately 12 people.
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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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Tolerability of group golf instruction compared to Tai Chi
時間枠：Both interventions will continue for 10 weeks and subject participation rates will be recorded during this time.
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The number of participants who complete 10 weeks in the study will be measured using weekly attendance sheets.
We will consider the intervention to be tolerable if the proportion of participants who withdraw consent prior to the end of the study is less than 40% with 80% confidence.
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Both interventions will continue for 10 weeks and subject participation rates will be recorded during this time.
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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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Safety of group golf instruction compared to Tai Chi
時間枠：Both interventions will continue for 10 weeks and any adverse events will be recorded during this time.
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The frequency of treatment-related adverse events including falls will be summarized by treatment group and system organ class by CTCAE v 4.0
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Both interventions will continue for 10 weeks and any adverse events will be recorded during this time.
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Key Secondary objectives are to measure the efficacy of golf instruction compared to Tai Chi on measures of balance.
時間枠：Both interventions will continue for 10 weeks. The Mini-BESTest will be performed by a blinded rater before and after the intervention period.
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The Mini-BESTest will be used to measure balance before and after the intervention.
The Mini-BESTest is scored from 0-28 where lower scores are better.
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Both interventions will continue for 10 weeks. The Mini-BESTest will be performed by a blinded rater before and after the intervention period.
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Activities Specific Balance Confidence Scale
時間枠：Both interventions will continue for 10 weeks. Participants will complete the questionnaire before and after the intervention period.
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This is a self-reported measure of confidence in performing various ambulatory activities without falling.
The scale is out of 100
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Both interventions will continue for 10 weeks. Participants will complete the questionnaire before and after the intervention period.
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.
- Li F, Harmer P, Fitzgerald K, Eckstrom E, Stock R, Galver J, Maddalozzo G, Batya SS. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012 Feb 9;366(6):511-9. doi: 10.1056/NEJMoa1107911.
- Gao KL, Hui-Chan CW, Tsang WW. Golfers have better balance control and confidence than healthy controls. Eur J Appl Physiol. 2011 Nov;111(11):2805-12. doi: 10.1007/s00421-011-1910-7. Epub 2011 Mar 17.
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 (実際)
2018年4月23日
一次修了 (実際)
2020年3月30日
研究の完了 (実際)
2020年6月1日
試験登録日
最初に提出
2018年5月8日
QC基準を満たした最初の提出物
2018年6月19日
最初の投稿 (実際)
2018年6月20日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月3日
QC基準を満たした最後の更新が送信されました
2020年9月2日
最終確認日
2020年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
パーキンソン病の臨床試験
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