Yoga Empowers Seniors Study (YESS)
2016年11月14日 更新者：George Salem、University of Southern California
Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations
This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program designed for community-dwelling older adults.
Additionally, the IDS will explore the adherence and adverse events of participation in the program.
Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs.
The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy.
The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.
調査の概要
詳細な説明
Yoga is currently being recommended to restore and preserve strength, flexibility, balance, & physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors.
To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, & safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.
研究の種類
介入
入学 (実際)
27
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
-
-
California
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Los Angeles、California、アメリカ、90024
- UCLA
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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年歳以上 (高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Community dwelling men and women volunteers, aged 65 years or older.
Exclusion Criteria:
Safety exclusions:
--the following safety exclusions are adopted in order to decrease potential *cardiovascular
- musculoskeletal
- neurological risks to the participants:
- active angina
- uncontrolled hypertension (SBP greater than 160 or DBP greater than 90)
- high resting pulse or respiratory rate (HR >90 or RR>24 after 5 minutes seated)
- unstable asthma or exacerbated COPD
- cervical spine instability or other significant neck injury
- rheumatoid arthritis
- unstable ankle, knee, hip, shoulder, elbow, or wrist joints
- hemiparesis or paraparesis
- movement disorders (e.g. Parkinson's disease), peripheral neuropathies, stroke with residual deficits, severe vision or hearing problems
- walker or wheelchair use
- insufficient hearing to permit safety in a yoga group setting
- not able to attend in-person classes
- has not had check-up by regular provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken); cannot pass specific movement safety tests (tests described in section on screening visits, below)
Feasibility/adherence exclusions:
- unable to understand their commitment to the project, (laboratory visits & regular program participation)
- cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety
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：基礎科学
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：yoga
32 weeks of yoga training
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yoga classes 2 times per week for 32 weeks
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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peak joint moments
時間枠：difference from baseline to 16 wk
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These are the torques produced by the muscles during performance of the yoga poses
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difference from baseline to 16 wk
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peak joint moments
時間枠：difference from 16 wk to 32 wk
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These are the torques produced by the muscles during performance of the yoga poses
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difference from 16 wk to 32 wk
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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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time to stand and sit from a chair 5 times
時間枠：baseline, 16 and 32 weeks
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In the 5-Repetition Chair Stand Test, we record the time it takes for a participant to repeatedly stand and sit on a chair 5 times.
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baseline, 16 and 32 weeks
|
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number of heel-rise repetitions
時間枠：baseline, 16 and 32 weeks
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The Heel-Rise Test is a measure of plantar-flexion endurance.
Here, we record the number of full range-of-motion, heel-rise repetitions the participants can complete before fatigue.
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baseline, 16 and 32 weeks
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Time to complete Up & Go test
時間枠：baseline, 16 and 32 weeks
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In the Up & Go Test, a measure of mobility, we record the number of seconds it takes to rise from a chair, walk 8 feet, return and sit in the chair.
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baseline, 16 and 32 weeks
|
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Number of marching steps completed within 2 minutes
時間枠：baseline, 16 and 32 weeks
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In the 2-Minute Step Test, a measure stepping endurance, we record the number of complete marching steps the participant can perform within a 2-minute period
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baseline, 16 and 32 weeks
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Distance participant can reach forward from a sitting position
時間枠：baseline, 16 and 32 weeks
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The sit and reach test measures overall sagittal-plane flexibility.
The participant is asked to reach as far as possible toward their dominant limb while remaining seated.
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baseline, 16 and 32 weeks
|
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Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.
時間枠：baseline, 16 and 32 weeks
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The Back Scratch Test measures upper extremity flexibility.
Here the distance between finger-tips is recorded as the participant reaches posteriorly and attempts to touch opposing hands.
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baseline, 16 and 32 weeks
|
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Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).
時間枠：baseline, 16 and 32 weeks
|
These tests measure the range of motion of the wrist in the sagittal and frontal planes.
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baseline, 16 and 32 weeks
|
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Maximum height participant can reach while standing
時間枠：baseline, 16 and 32 weeks
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Here we quantify the maximum vertical height participants can reach while standing.
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baseline, 16 and 32 weeks
|
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Maximum distance participant can reach forward while standing
時間枠：baseline, 16 and 32 weeks
|
THe Maximum Forward Reach test is a measure of strength and flexibility.
Here we record the maximum distance the participant can reach forward while standing.
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baseline, 16 and 32 weeks
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stride length during walking
時間枠：baseline, 16 and 32 weeks
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Here we quantify the stride length of participants during walking at a self-selected pace.
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baseline, 16 and 32 weeks
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Maximum joint angle
時間枠：baseline, 16 and 32 weeks
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Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.
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baseline, 16 and 32 weeks
|
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Sway distance of the center of pressure
時間枠：baseline, 16 and 32 weeks
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Here we quantify the movement of the center of pressure as participants stand as still as possible
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baseline, 16 and 32 weeks
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Electromyographic activity of muscles
時間枠：baseline, 16 and 32 weeks
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Here we record the electromyographic activity of the Anterior Deltoid, Triceps surae, Obliques, Rectus Abdominus, Erector Spinae, Gluteus Maximus, Lateral Hamstrings, Vastus Lateralis, Gastrocnemius, and Gluteus Medius, muscles during performance of the yoga poses.
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baseline, 16 and 32 weeks
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SF-36 score
時間枠：baseline and 36 weeks
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Health related quality of life and mood will be assessed with the RAND Short Form-36 (Hays, 1993).
The SF-36 includes sub-scales that measure: 1) health-related limitations in physical function; 2) health-related limitations in role and in social function; 3) emotional function (including positive and negative mood states); 4) pain.
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baseline and 36 weeks
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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
- 主任研究者：george salem, phd、University of Southern California
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。
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
2009年7月1日
一次修了 (実際)
2011年4月1日
研究の完了 (実際)
2011年4月1日
試験登録日
最初に提出
2011年7月20日
QC基準を満たした最初の提出物
2011年8月4日
最初の投稿 (見積もり)
2011年8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16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14日
最終確認日
2016年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1R01AT004869-01 (米国 NIH グラント/契約)
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