ObeseNCT07627919
Effect of Combined Resisted Training and Protein-based Diet on Frailty in Sarcopenic Elderly Women
A study testing supervised resistance exercise training and a and high -protein diet in people with Obese and Sarcopenic Obesity, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 70 years, women only
- Conditions the study is for
- Obese, Sarcopenic Obesity
- What is being tested?
- supervised resistance exercise training and a and high -protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Fawkia hospital outpatient clinic
El-Sheikh Zayed City
Nesreen El-nahas, phd, info@pt.cu.edu.eg
About this study
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.
Read the detailed description
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.
- Conditions
- Obese, Sarcopenic Obesity
- Being tested
- supervised resistance exercise training and a, high -protein diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised resistance exercise training and aOther
supervised resistance exercise training three times per week
high -protein dietOther
a high-protein diet (1.3 g protein/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: high -protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
Health-Related Quality of Life
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
Measured: 12 weeks
hallmarks of sarcopenia
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.
Measured: 12 weeks
Muscle quality index
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.
Measured: 12 weeks
Handgrip strength assessment
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).
Measured: 12 weeks
Waist-to-hip ratio assessment
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.
Measured: 12 weeks
body mass index
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))
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaaelsayed, Cairo University
- Investigators
- shaimaa elsayed, master, Principal investigator, Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627919
- Sponsor's protocol ID
- P.T.REC/012/006131
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Resisted Training and Protein-based Diet on Frailty in Sarcopenic Elderly Women
- ClinicalTrials.gov ID
- NCT07627919
- Acronym / sponsor ID
- P.T.REC/012/006131
- Conditions
- Obese, Sarcopenic Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (combined intervention group) | Experimental | Other: supervised resistance exercise training and a, Other: high -protein dietGroup 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) | Active comparator | Other: high -protein dietGroup 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. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised resistance exercise training and asupervised resistance exercise training three times per week | Other | Group A (combined intervention group) |
| high -protein dieta high-protein diet (1.3 g protein/kg/day) | Other | Group A (combined intervention group), Group B (control group) |
Primary outcome
balance assessment
Time frame: 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.
6 secondary outcomes
Health-Related Quality of Life
Time frame: 12 weeks
hallmarks of sarcopenia
Time frame: 12 weeks
Muscle quality index
Time frame: 12 weeks
Handgrip strength assessment
Time frame: 12 weeks
Waist-to-hip ratio assessment
Time frame: 12 weeks
body mass index
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
shaimaa elsayed, master principal investigator
Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised resistance exercise training and a and high -protein diet in people with Obese and Sarcopenic Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa Elsayed, master (01063923818, drshaimaaelsayed1210@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.