Geriatric SarcopeniaNCT07399301
High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia
A study testing High-Intenisity Functional Training in people with Geriatric Sarcopenia, run by Cairo University at 1 site in Egypt.
Trial summary
Sixty patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Geriatric Sarcopenia
- What is being tested?
- High-Intenisity Functional Training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Sep 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Old individuals who will be found to have sarcopenia as defined according to European Working Group on Sarcopenia in Older People (EWGSOP2) 2019 criteria, The EWGSOP2 defines sarcopenia as a muscle disease characterized by progressive and generalized loss of skeletal muscle mass and function. Diagnosis requires sequential assessment of three components
- Low Muscle Strength: The primary criterion. Measured by:
- Handgrip strength: Cut-offs are <27 kg for men and <16 kg for women using a dynamometer.
- Chair Stand Test: ≥15 seconds for five rises indicates weakness.
- Low Muscle Quantity or Quality: Assessed via:
- o calf circumference (≤34 cm men, ≤33 cm women).
Show all 12Show fewer
- Poor Physical Performance: Indicates severe sarcopenia. Tests include:
- Gait speed: ≤0.8 m/s over 4 meters.
- Short Physical Performance Battery (SPPB): ≤8 points.
- Timed Up-and-Go (TUG): ≥20 seconds.
- Age from 60 to 70 years old.
- Old individuals who will be found to have mild depression.
Who cannot join
- Neurological disorders.
- Vestibular or balance disorders.
- Uncontrolled hypertension or heart diseases.
- Recent surgeries or fractures.
- Any psychological disorders.
- Severe renal failure (glomerular filtration rate < 30 mL/min).
- moderate to severe liver failure.
- The patients cannot follow instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Research Ethical Committee Faculty of Physical Therapy - Cairo University contact
Egypt1 site
Faculty of Physical Therapy
Giza, 12613
Research Ethical Committe Faculty of Physical Therapy, 01151312322, eth.com@pt.cu.edu.eg
About this study
Official title: Effect of High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia
Sixty patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah.
Patients will be assigned into two equal groups randomly:
Read more
Group(A):N= 30
Patients in this group will receive high-intensity functional training exercises 3 times per week for 10 weeks. The initial duration of each session was 30 min, and it could be increased progressively, along with the intensity of the exercises, up to 50 min. All sessions included the following:
- 5 min warm-up ii. 40 min functional training exercises. iii. 5 min cool-down. Group (B): N=30 Patients in this group will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.
Read the detailed description
Sixty patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah.
Patients will be assigned into two equal groups randomly:
Group (B): N=30 Patients in this group will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants
Procedures:
(A)Evaluating procedures: Before starting the exercise program, a complete history and physical examination will be taken from each subject. Each subject of the two groups will undergo the following steps of measurements. The parameters will be recorded at the beginning and the end of the total study period (10 weeks).
- Hand Dynamometer.
- Short Physical Performance.
- Quadriceps strength test
- Montreal Cognitive Assessment
- The Katz Index.
- The Geriatric Depression Scale-15 (GDS-15).
- The UCLA Loneliness Scale (Version 3). (B) Intervention procedures: All patients will be classified into two equal groups; each group will consist of 30 patients.
I-Intervention for Group A :
Patients in this group will receive high-intensity functional training exercises 3 times per week for 10 weeks. The initial duration of each session was 30 min, and it could be increased progressively, along with the intensity of the exercises, up to 50 min. All sessions included the following:
- 5 min warm-up ii. 40 min functional training exercises. Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study.
- Sit to stand( Chair squats) II. Wall push up III. Overhead triceps extension IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min
II. Intervention for Group B :
The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants.
- Conditions
- Geriatric Sarcopenia
- Being tested
- High-Intenisity Functional Training, Sham
- Keywords
- HIGH- INTENSITY FUNCTIONAL TRAINING- PHYSICAL PERFORMANCE - MENTAL HEALTH - ELDERLY - SARCOPENIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intenisity Functional TrainingOther
- Awarm up: for 5 min.warm-up (predominantly stretching) of the neck, shoulders, lower back, hips, knees and ankles.
- Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study.
- Sit to stand( Chair squats) II. Wall push up III. Overhead triceps extension IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min slow continuation of the activity, allows a more gradual reduction in heart rate and increased peripheral vascular resistance, with return of blood flow from the periphery Farmer's Carry training
ShamOther
The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity functional training exercises | Experimental | A) Awarm up: for 5 min, B) Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study I. Sit to stand( Chair squats)
II. Wall push up:
III. Overhead triceps extension:
IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min slow continuation of the activity. Receives: Other: High-Intenisity Functional Training |
| sham therapy | Sham comparator | Group (B): N=30 Patients in this group who will be found to have sarcopenia will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.Sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB) test
The SPPB assesses physical performance through balance, strength, and gait measurements and is made up of a set of three tests: standing static balance ; lower limb strength and power through getting up and sitting on a chair; and walking speed at normal pace. Strength and gait are first evaluated by the ability to perform the tasks of getting up and sitting on a chair five times and performing the walking speed test (3 to 4 meters) and, second, by the time the individual takes to complete the tasks. The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance).
Measured: 10 weeks
Secondary outcomes (6)
Hand Dynamometer
Are portable devices usually incorporating a wireless load cell with an inbuilt microprocessor to measure isometric muscle force across both clinical and healthy populations.To assess hand grip, participants will sit in a chair with their feet support. The hand and forearm will assess by position with the shoulder adducted and in neutral rotation, with the elbow in 90◦ of flexion, forearm in neutral, and the wrist in 0 to 30◦ of extension and 0 to 15◦ of ulnar deviation. The participant will ask to grasp the hand-held dynamometer with the fingers wrapped around the handle. The clinical evaluator instructed the participant to perform a maximal contraction lasting three to five seconds, saying, "when I say go, I want you to squeeze the handle as hard as you can.
Measured: 10 weeks
Quadriceps strength test
manual muscle testing (MMT) is a highly reliable method for assessing strength. The patient is sitting upright and positioned to allow full movement of the joint against gravity. The examiner will demonstrate the desired movement against gravity. Verbal instructions; "Straighten your knee". The hand will give resistance on top of the leg just proximal to the ankle. The other hand is placed under the thigh above the knee.
Measured: 10 weeks
Montreal Cognitive Assessment
Is a diagnostic test for Mild cognitive impairment. A score of 90 or more indicates normality, 89-78 is an indication of MCI, and a score lower than 78 is diagnostic for dementia.
Measured: 10 weeks
The Katz Index
Is designed to assess functional status, specifically, the individual's ability to perform activities of daily living (ADLs) independently. The index ranks the performance in the following six functions: bathing, dressing, toileting, transferring, continence, and feeding. If no supervision, direction, or personal assistance is required, then 1 point is given to that functional activity. If the individual requires supervision, direction, personal assistance, or total care, then a 0 is assigned to that functional activity. A total score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Measured: 10 weeks
The Geriatric Depression Scale-15 (GDS-15)
The scale contains 15 items, and the answers are composed of "yes/no", with the total score ranging from 0 to 15. The scale mainly evaluates the depression status of participants in the recent week.The total score >5 was classified as depression positive
Measured: 10 weeks
The UCLA Loneliness Scale (Version 3)
the measure was highly reliable, both in terms of internal consistency and test-retest reliability over a 1-year period. Hardly ever or never = 1; some of the time = 2; often = 3. The lowest possible combined score on the loneliness scale is 3 (indicating less frequent loneliness) and the highest is 9 (indicating more frequent loneliness)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric SarcopeniaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Mohammed Ibrahim Nawar, Cairo University
- Investigators
- Research Ethical Committee Faculty of Physical Therapy - Cairo University, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399301
- Sponsor's protocol ID
- 202663
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 20 Apr 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia
- ClinicalTrials.gov ID
- NCT07399301
- Acronym / sponsor ID
- 202663
- Conditions
- Geriatric Sarcopenia
- Keywords
- HIGH- INTENSITY FUNCTIONAL TRAINING- PHYSICAL PERFORMANCE - MENTAL HEALTH - ELDERLY - SARCOPENIA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Feb 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 patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah.
Patients will be assigned into two equal groups randomly:
Group(A):N= 30
Patients in this group will receive high-intensity functional training exercises 3 times per week for 10 weeks. The initial duration of each session was 30 min, and it could be increased progressively, along with the intensity of the exercises, up to 50 min. All sessions included the following:
- 5 min warm-up ii. 40 min functional training exercises. iii. 5 min cool-down. Group (B): N=30 Patients in this group will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.
Detailed description
Sixty patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah.
Patients will be assigned into two equal groups randomly:
Group (B): N=30 Patients in this group will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants
Procedures:
(A)Evaluating procedures: Before starting the exercise program, a complete history and physical examination will be taken from each subject. Each subject of the two groups will undergo the following steps of measurements. The parameters will be recorded at the beginning and the end of the total study period (10 weeks).
- Hand Dynamometer.
- Short Physical Performance.
- Quadriceps strength test
- Montreal Cognitive Assessment
- The Katz Index.
- The Geriatric Depression Scale-15 (GDS-15).
- The UCLA Loneliness Scale (Version 3). (B) Intervention procedures: All patients will be classified into two equal groups; each group will consist of 30 patients.
I-Intervention for Group A :
Patients in this group will receive high-intensity functional training exercises 3 times per week for 10 weeks. The initial duration of each session was 30 min, and it could be increased progressively, along with the intensity of the exercises, up to 50 min. All sessions included the following:
- 5 min warm-up ii. 40 min functional training exercises. Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study.
- Sit to stand( Chair squats) II. Wall push up III. Overhead triceps extension IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min
II. Intervention for Group B :
The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity functional training exercises | Experimental | Other: High-Intenisity Functional TrainingA) Awarm up: for 5 min, B) Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study I. Sit to stand( Chair squats) II. Wall push up: III. Overhead triceps extension: IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min slow continuation of the activity. |
| sham therapy | Sham comparator | Other: ShamGroup (B): N=30 Patients in this group who will be found to have sarcopenia will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.Sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Old individuals who will be found to have sarcopenia as defined according to European Working Group on Sarcopenia in Older People (EWGSOP2) 2019 criteria, The EWGSOP2 defines sarcopenia as a muscle disease characterized by progressive and generalized loss of skeletal muscle mass and function. Diagnosis requires sequential assessment of three components
- o calf circumference (≤34 cm men, ≤33 cm women).
- Age from 60 to 70 years old.
- Old individuals who will be found to have mild depression.
Key exclusion criteria (8 listed)
- Neurological disorders.
- Vestibular or balance disorders.
- Uncontrolled hypertension or heart diseases.
- Recent surgeries or fractures.
- Any psychological disorders.
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 |
|---|---|---|
| High-Intenisity Functional TrainingA) Awarm up: for 5 min.warm-up (predominantly stretching) of the neck, shoulders, lower back, hips, knees and ankles. B) Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study. I. Sit to stand( Chair squats) II. Wall push up III. Overhead triceps extension IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min slow continuation of the activity, allows a more gradual reduction in heart rate and increased peripheral vascular resistance, with return of blood flow from the periphery Farmer's Carry training | Other | high-intensity functional training exercises |
| ShamThe participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants. | Other | sham therapy |
Primary outcome
Short Physical Performance Battery (SPPB) test
Time frame: 10 weeks
The SPPB assesses physical performance through balance, strength, and gait measurements and is made up of a set of three tests: standing static balance ; lower limb strength and power through getting up and sitting on a chair; and walking speed at normal pace. Strength and gait are first evaluated by the ability to perform the tasks of getting up and sitting on a chair five times and performing the walking speed test (3 to 4 meters) and, second, by the time the individual takes to complete the tasks. The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance).
6 secondary outcomes
Hand Dynamometer
Time frame: 10 weeks
Quadriceps strength test
Time frame: 10 weeks
Montreal Cognitive Assessment
Time frame: 10 weeks
The Katz Index
Time frame: 10 weeks
The Geriatric Depression Scale-15 (GDS-15)
Time frame: 10 weeks
The UCLA Loneliness Scale (Version 3)
Time frame: 10 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 20 Apr 2026.
Related trials for Geriatric Sarcopenia
RecruitingObservational study
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Colorectal Cancer, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
Enrolling by invitationObservational study
Multidimensional Determinants of Functional Health In Women Aged 45-60
Healthy, Perimenopausal Depression
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.
Research Ethical Committee Faculty of Physical Therapy - Cairo University contact
Research Ethical Committee Faculty of Physical Therapy - Cairo University principal investigator
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 High-Intenisity Functional Training in people with Geriatric Sarcopenia, 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 12 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 Apr 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. Some participants in this study may receive a placebo. 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 Research Ethical Committee Faculty of Physical Therapy - Cairo University (01151312322, eth.com@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) test (time frame: 10 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 20 Apr 2026.