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Effect of Combined Resisted Training and Protein-based Diet on Frailty in Sarcopenic Elderly Women

2026년 5월 30일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 이집트
      • El-Sheikh Zayed City, 이집트
        • 모병
        • Fawkia hospital outpatient clinic
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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)
다른: supervised resistance exercise training and a
supervised resistance exercise training three times per week
다른: high -protein diet
a high-protein diet (1.3 g protein/kg/day)
활성 비교기: 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.
다른: high -protein diet
a high-protein diet (1.3 g protein/kg/day)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
balance assessment
기간: 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.
12 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Health-Related Quality of Life
기간: 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
12 weeks
hallmarks of sarcopenia
기간: 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.
12 weeks
Muscle quality index
기간: 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.
12 weeks
Handgrip strength assessment
기간: 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).
12 weeks
Waist-to-hip ratio assessment
기간: 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.
12 weeks
body mass index
기간: 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))
12 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Cairo University

수사관

  • 수석 연구원: shaimaa elsayed, master, Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 30일

기본 완료 (추정된)

2027년 5월 30일

연구 완료 (추정된)

2027년 12월 30일

연구 등록 날짜

최초 제출

2026년 5월 30일

QC 기준을 충족하는 최초 제출

2026년 5월 30일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 30일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • P.T.REC/012/006131

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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