- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399301
High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia
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:
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:
i. 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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
i. 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.
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
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research Ethical Committee Faculty of Physical Therapy - Cairo University
- Phone Number: 01151312322
- Email: eth.com@pt.cu.edu.eg
Study Locations
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Giza, Egypt, 12613
- Faculty of Physical Therapy
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Contact:
- Research Ethical Committe Faculty of Physical Therapy
- Phone Number: 01151312322
- Email: eth.com@pt.cu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: INCLUSION CRITERIA:
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).
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: high-intensity functional training exercises
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. |
A) 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 |
|
Sham Comparator: sham therapy
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Dynamometer
Time Frame: 10 weeks
|
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.
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10 weeks
|
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Quadriceps strength test
Time Frame: 10 weeks
|
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.
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10 weeks
|
|
Montreal Cognitive Assessment
Time Frame: 10 weeks
|
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.
|
10 weeks
|
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The Katz Index
Time Frame: 10 weeks
|
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.
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10 weeks
|
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The Geriatric Depression Scale-15 (GDS-15)
Time Frame: 10 weeks
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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
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10 weeks
|
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The UCLA Loneliness Scale (Version 3)
Time Frame: 10 weeks
|
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)
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10 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Research Ethical Committee Faculty of Physical Therapy - Cairo University, Cairo university
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202663
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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