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

NCT07627919 | Recruiting

• 1 other identifier: P.T.REC/012/006131
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obese; Sarcopenic Obesity

Outcome Measures

Primary Outcomes (1)

• balance assessment

  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

Secondary Outcomes (6)

• Health-Related Quality of Life

  12 weeks

• hallmarks of sarcopenia

  12 weeks

• Muscle quality index

  12 weeks

• Handgrip strength assessment

  12 weeks

• Waist-to-hip ratio assessment

  12 weeks

Study Arms (2)

Group A (combined intervention group)

EXPERIMENTAL

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)

Other: supervised resistance exercise training and a; Other: high -protein diet

Group B (control group)

ACTIVE COMPARATOR

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.

Other: high -protein diet

Interventions

supervised resistance exercise training and a OTHER

supervised resistance exercise training three times per week

Group A (combined intervention group)

high -protein diet OTHER

a high-protein diet (1.3 g protein/kg/day)

Group A (combined intervention group); Group B (control group)

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• \) 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.
• \) Patients didn't follow any exercise program before treatment at least 4 weeks ago.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Fawkia hospital outpatient clinic

El-Sheikh Zayed City, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• shaimaa elsayed, master

  Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaimaa Elsayed, master

CONTACT

01063923818; drshaimaaelsayed1210@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

EG (1)