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

30 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
      • El-Sheikh Zayed City, Egitto
        • Reclutamento
        • Fawkia hospital outpatient clinic
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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)
Altro: supervised resistance exercise training and a
supervised resistance exercise training three times per week
Altro: high -protein diet
a high-protein diet (1.3 g protein/kg/day)
Comparatore attivo: 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.
Altro: high -protein diet
a high-protein diet (1.3 g protein/kg/day)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
balance assessment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Health-Related Quality of Life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

30 maggio 2027

Completamento dello studio (Stimato)

30 dicembre 2027

Date di iscrizione allo studio

Primo inviato

30 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P.T.REC/012/006131

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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