Effect of Combined Resisted Training and Protein-based Diet on Frailty in Sarcopenic Elderly Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-70
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
supervised resistance exercise training and a
Other interventionsupervised resistance exercise training three times per week
high -protein diet
Other interventiona high-protein diet (1.3 g protein/kg/day)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group A (combined intervention group)Experimental treatment 2 interventions
Group B: Group B (control group)Active comparator 1 intervention
Trial outcomes
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.
Time frame
12 weeksSecondary outcomes
1
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
Time frame
12 weeks2
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.
Time frame
12 weeks3
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.
Time frame
12 weeks4
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).
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov