The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals
2019年3月12日 更新者:Truls Raastad、Norwegian School of Sport Sciences
Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity
The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals.
Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group.
The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity.
The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance.
Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.
調査の概要
詳細な説明
Aging is accompanied by a loss of muscle mass and strength.
Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline.
The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function.
The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail.
Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest.
Strategies to improve functional capacity in this population are therefore important.
It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals.
However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals.
Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely.
Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity.
Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group.
In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period.
The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.
研究の種類
介入
入学 (実際)
22
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
-
-
-
Oslo、ノルウェー、0863
- Norwegian School of Sport Sciences
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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
75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:
- Age > 75
- Short Physical Performance Battery (SPPB) score ≤ 10
Exclusion Criteria:
- Lactose intolerance
- Milk allergy
- Diseases or musculoskeletal disorders contraindicating training/testing
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:ランダム化
- 介入モデル:並列代入
- 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 |
---|---|
介入なし:コントロール
介入なし
|
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実験的:Strength training + protein supplement
Heavy-load strength training, Protein supplementation
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Three weekly sessions of heavy-load strength training for 10 weeks
他の名前:
Daily supplementation of 2 x 17 grams of milk protein
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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 |
---|---|---|
Muscle strength of m. Quadriceps Femoris
時間枠:Change from baseline at 10 weks
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Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)
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Change from baseline at 10 weks
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Muscle strength of m. quadriceps femoris
時間枠:Change from baseline at 10 weeks
|
Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)
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Change from baseline at 10 weeks
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Leg lean mass
時間枠:Change from baseline at 10 weeks
|
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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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 |
---|---|---|
メートル。外側広筋の厚さ
時間枠:10週でのベースラインからの変化
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超音波で測定
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10週でのベースラインからの変化
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Total lean mass
時間枠:Change from baseline at 10 weeks
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Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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Fat mass
時間枠:Change from baseline at 10 weeks
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Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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Bone mineral density
時間枠:Change from baseline at 10 weeks
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Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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m. Rectus Femoris thickness
時間枠:Change from baseline at 10 weeks
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Measured by ultrasound
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Change from baseline at 10 weeks
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m. Vastus Intermedius thickness
時間枠:Change from baseline at 10 weeks
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Measured by ultrasound
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Change from baseline at 10 weeks
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m. Vastus Medialis thickness
時間枠:Change from baseline at 10 weeks
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Measured by ultrasound
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Change from baseline at 10 weeks
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Isometric knee extension rate of force development (RFD max)
時間枠:Change from baseline at 10 weeks
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Measured during maximal voluntary contraction
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Change from baseline at 10 weeks
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Isometric knee extension force at 100 ms
時間枠:Change from baseline at 10 weeks
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Force at 100 ms during maximal voluntary contraction
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Change from baseline at 10 weeks
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Habitual gait velocity
時間枠:Change from baseline at 10 weeks
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Time (sec) to walk 6 meters at preferred gait speed
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Change from baseline at 10 weeks
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Five times chair-rise performance
時間枠:Change from baseline at 10 weeks
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Time (sec) to rise from a chair five times
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Change from baseline at 10 weeks
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Stair climbing
時間枠:Change from baseline at 10 weeks
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Time (sec) to climb a staircase
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Change from baseline at 10 weeks
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Diet assessment
時間枠:Change from baseline at 10 weeks
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24-hour diet recall interviews
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Change from baseline at 10 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。
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)
2015年7月1日
一次修了 (実際)
2015年12月21日
研究の完了 (実際)
2015年12月21日
試験登録日
最初に提出
2018年10月26日
QC基準を満たした最初の提出物
2018年10月29日
最初の投稿 (実際)
2018年10月30日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月14日
QC基準を満たした最後の更新が送信されました
2019年3月12日
最終確認日
2019年3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。