Effect of Combined Resisted Training and Protein-based Diet on Frailty in Sarcopenic Elderly Women
2026年5月30日 更新者：shaimaaelsayed、Cairo University
Sixty obese elderly women will be recruited from Fawkia hospital outpatient clinic diagnosed by sarcopenia and randomly allocated into two groups for a 12-week intervention. Patients will be divided into 2 groups (A and B):
- Group A (combined intervention group: n=30): will perform supervised resistance exercise training three times per week and follow a high-protein diet (1.3 g protein/kg/day)
- Group B (control group: n=30): will receive a high-protein diet and general health advices and be asked to maintain their usual lifestyle. They will be offered the intervention post-study.
調査の概要
詳細な説明
Group A (combined intervention):
Resistance Exercise:
The exercise program involved resistance training 3 days a week for 1-h sessions. The training started with a 10-min warming up followed by two sets of 50 s of the following exercises: leg press, knee extensions, leg curls, chest press, seated row, plantar flexion, and sit-to-stand exercises. During the 12-week period the number of sets was gradually increased from 2 - 3 set for all exercises, the time to perform the exercises increased from 50 - 75 s, and resistance was increased by using dumbbells, elastic bands, medicine balls and a step bench. The training ended with 5-min cooling down. Attendance to the training sessions was recorded.
Dietary intervention:
- Protein intake: 1.3 grams of protein per kilogram of body weight per day.
- Distribution: protein intake will be evenly distributed across meals (≥ 30g per meal).
- Monitoring: participants will keep 3-day dietary records every two weeks. Group B (control group): will receive high protein plan and a single session of general advices on the importance of physical activity based on national guidelines. They will be contacted every two weeks for general check-ins to maintain engagement but will not receive structured exercise or dietary planning.
研究の種類
介入
入学 (推定)
60
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。
研究連絡先
- 名前：Shaimaa Elsayed, master
- 電話番号：01063923818
- メール：drshaimaaelsayed1210@gmail.com
研究場所
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-
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El-Sheikh Zayed City、エジプト
- 募集
- Fawkia hospital outpatient clinic
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コンタクト：
- Nesreen El-nahas, phd
- メール：info@pt.cu.edu.eg
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
1) Female gender 2) Age 60-70 years 3) BMI ≥ 30 kg/m2 4) Sarcopenic patients diagnosed by their physicians according to EWGSOP2 criteria (low muscle strength confirmed by handgrip strength or chair stand test, plus low muscle quantity confirmed by BIA or DXA), and SARC-F score >3.
5) Ambulatory and able to participate in exercise. 6) Stable medical condition. 7) The patients didn't follow any type of diet before the treatment at least 4 weeks ago.
8) Patients didn't follow any exercise program before treatment at least 4 weeks ago.
Exclusion Criteria:
- 1) Sever cardiovascular, pulmonary, renal, or hepatic disease. 2) Uncontrolled diabetes or hypertension. 3) Neurological or musculoskeletal disorders prohibiting exercise 4) Cancer or other terminal illness. 5) Current use of anti-inflammatory drugs or steroids. 6) Metal implants prohibiting BIA assessment. 7) Cognitive impairment impairing ability to consent or follow instructions. 8) Using drugs that would affect metabolism or balance. 9) Using assistive devices for walking.
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：処理
- 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：Group A (combined intervention group)
Group A (combined intervention group: n=30): will perform supervised resistance exercise training three times per week and follow a high -protein diet (1.3 g protein/kg/day)
|
supervised resistance exercise training three times per week
a high-protein diet (1.3 g protein/kg/day)
|
|
アクティブコンパレータ：Group B (control group)
Group B (control group: n=30): will receive high protein diet and general health advices and be asked to maintain their usual lifestyle.
They will be offered the intervention post-study.
|
a high-protein diet (1.3 g protein/kg/day)
|
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 |
|---|---|---|
|
balance assessment
時間枠：12 weeks
|
The Biodex Balance System SD features five test protocols and six training modes, allowing for both testing and training in either static or dynamic formats.
It is intended to be a system that can provide accurate Fall Risk Screening and conditioning for older adults, can be used as a balance assessment tool for concussion management, and can serve as weight-bearing assessment and training for lower extremity injuries.
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12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Health-Related Quality of Life
時間枠：12 weeks
|
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life.
The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).
Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
All raw responses must be converted to a scale of 0 to 100, where 100 represents the most favorable health state (absence of limitations) and 0 indicates the worst health state
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12 weeks
|
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hallmarks of sarcopenia
時間枠：12 weeks
|
The SARC-F questionnaire contains five self-reported items evaluating the hallmarks of sarcopenia, that is, functional deficits and falls.
Each item has a possible score of 0 to 2 points, with higher scores suggesting a higher risk of sarcopenia.
A total score of >3 is regarded as a positive screening result.
Higher SARC-F scores have been shown to correlate with a slower chair rise, lower gait speed, overall lower SPPB scores, as well as adverse outcomes related to sarcopenia The SARC-F has a low-to-moderate sensitivity but high specificity, thus providing a well-suited screening test to identify individuals who are not at high risk of sarcopenia-related negative outcomes.
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12 weeks
|
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Muscle quality index
時間枠：12 weeks
|
The Muscle Quality Index (MQI) is a performance-based functional assessment involving ten repetitions of the sit-to-stand maneuver performed as rapidly as possible.
The test requires the use of a scale to record body mass, a tape measure to obtain leg length, along with a stopwatch and chair and for the timed functional task.
The MQI score is calculated using the formula provided by Takai et al: ((leg length × 0.4) × body mass × gravity × 10)/sit-to-stand time.
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12 weeks
|
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Handgrip strength assessment
時間枠：12 weeks
|
Handgrip strength assessment will be assessed using a digital hand dynamometer.
The participants held an ergonomic position to perform the test, sitting upright in a chair with a backrest but no armrests.
The feet will be maintained on the floor with 90° knee flexion.
The arm will be positioned with 90° elbow flexion and neutral forearm pronosupination.
The subjects will receiveexplanation of the dynamometer.
A single blinded instructor encouraged participants to produce their maximal HGS with their dominant hand.
The best result of three attempts with a 1-min pause between will be documented in kilograms (kg).
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12 weeks
|
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Waist-to-hip ratio assessment
時間枠：12 weeks
|
The waist circumference will be measured at the narrowest point between the ribs and hips.
The individual will stand with feet together and exhale gently.
The measuring tape will be comfortably snug but will not press into the skin.
The hip circumference will be measured at the widest part of the buttocks.
The measuring tape is positioned parallel to the ground and encircled the hip bones.
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12 weeks
|
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body mass index
時間枠：12 weeks
|
Using body weight scale with height (m) scale to be able to calculate body mass index (kg) to all subject before starting the study BMI=(weight(kg))/(height2 (m2))
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12 weeks
|
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。
スポンサー
捜査官
- 主任研究者：shaimaa elsayed, master、Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
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 (推定)
2026年6月30日
一次修了 (推定)
2027年5月30日
研究の完了 (推定)
2027年12月30日
試験登録日
最初に提出
2026年5月30日
QC基準を満たした最初の提出物
2026年5月30日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年5月30日
最終確認日
2026年5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。