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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое supervised resistance exercise training and a
  supervised resistance exercise training three times per week
• Другое high -protein diet
  a high-protein diet (1.3 g protein/kg/day)

Первичные конечные точки

• balance assessment [Срок оценки: 12 weeks]

Вторичные конечные точки (6)

• Health-Related Quality of Life [Срок оценки: 12 weeks]
• hallmarks of sarcopenia [Срок оценки: 12 weeks]
• Muscle quality index [Срок оценки: 12 weeks]
• Handgrip strength assessment [Срок оценки: 12 weeks]
• Waist-to-hip ratio assessment [Срок оценки: 12 weeks]
• body mass index [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Fawkia hospital outpatient clinic — El-Sheikh Zayed City

Идентификаторы

NCT: NCT07627919 · P.T.REC/012/006131

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗