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IRCT20230304057612N1 IRCT 2023-04-26 Tehran University of Medical Sciences Long-Term Effects of Whole-Body Vibration on Sarcopenia in Geriatric Population Comparison of long-term effects of active range of motion exercises with and without whole-body vibration on skeletal muscle index and physical performance in elderly population with sarcopenia 2023-05-21 anticipated 56 Complete https://irct.ir/trial/69234 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A stratified block randomization method will be used using "Random Allocation Software", to achieve balance among groups. For this purpose, there are random blocks with a block size of 4 and an allocation ratio of 1 male to 1 female. After this step, a simple randomization procedure (flipping a coin) will be used to assign the participants within each block to one of the experimental or control groups. Therefore, there will be 4 groups with equal sizes, Blinding description: The assessor will be blinded to the participants’ allocation before intervention and posttest measures obtained after intervention. The patients will be unaware of which group they are allocated to. N/A Sarcopenia. Intervention 1: Intervention group: It will contain subgroups of an equal number of males and females. This group will receive 10 bouts of WBV with frequency progressively increasing from 15 to 40 Hz (15Hz for 1st and 2nd week, 20Hz for 3rd and 4th week, 30Hz for 5th and 6th week, 40Hz for 7th and 8th week) and Amplitude 1.2 mm with linear vibration in the dynamic partial squat position while isometrically contracting quadriceps muscles during each vibration period (60 seconds), keeping knees and hips slightly flexed (20°) with 1 minute rest in between each bout for three days a week for 8 weeks. During treatment, participants will be made to hold hand railing under supervision of a trained physical therapist. Additionally, they will perform upper and lower limb active exercises against gravity with 10 repetitions for all movements on each joint with 2 minutes rest in between. Intervention 2: Control group: It will contain subgroups of an equal number of males and females. Control group will be made to perform 10 repetitions of similar dynamic partial squats with same position (knees and hips 20° flexed while isometrically contracting quadriceps muscles) and duration (60 seconds followed by 1-minute rest in between each repetition), three times a week for 8 weeks as in intervention group with vibration platform turned off. During treatment, participants will be made to hold hand railing under supervision of a trained physical therapist. Additionally, they will perform upper and lower limb active exercises against gravity with 10 repetitions for all movements on each joint with 2 minutes rest in between. No - There is not a plan to make this available Justification or reason for not sharing IPD is Sharing IPD is of no use for our study. We should consider the whole sample size.
public Shafaq Altaf
House 64, Street 59, I-8/3, Islamabad
Islamabad Pakistan 44000 +92 343 5020507 shafaq.altaf.shah@gmail.com Tehran University of Medical Sciences scientific Dr. Kazem Malmir
School of Rehabilitation, No. 336, Next to Safialishah Street, Piche Shemiran, Enghelab Avenue
Tehran Iran (Islamic Republic of) 1148965111 +98 919 588 9548 kmalmir@sina.tums.ac.ir Tehran University of Medical Sciences Pakistan Elderly aged 60 years and above Participants who meet sarcopenia diagnostic criteria based on the EWGSOP2 algorithm for case-finding and diagnosis with Skeletal Muscle Index (SMI) <7.0 kg/m2 and <5.5 kg/m2 for males and females, respectively Negative Romberg's sign Participants who are willing to comply with the study protocol and give informed consent in writing 60 years no limit Both Participants who meet “severe” sarcopenia diagnostic criteria based on the EWGSOP2 algorithm for case-finding and diagnosis with a score of ≤8 on Short Physical Performance Battery (SPPB) Presence of any neuromuscular, autoimmune, or infectious diseases Participants with Total Hip Replacement, Total Knee Replacement and any other lower limb implants Participants unable to flex the knee joints to 90° or having pain in their knees or ankles due to any problem such as arthritic changes Participants with any critical cognitive (Mini–Mental State Examination, MMSE score < 23) or physical dysfunctions that may interfere with the test or training procedures Participants with cardiovascular and/or pulmonary diseases, which can get aggravated after exercise Participants who are taking drugs that can affect the neuromuscular system Participants who are osteoporotic with T-score < -2.5 on DEXA at the lumbar spine/ femoral neck/distal third of the radius Rehabilitation Rehabilitation Intervention group: It will contain subgroups of an equal number of males and females. This group will receive 10 bouts of WBV with frequency progressively increasing from 15 to 40 Hz (15Hz for 1st and 2nd week, 20Hz for 3rd and 4th week, 30Hz for 5th and 6th week, 40Hz for 7th and 8th week) and Amplitude 1.2 mm with linear vibration in the dynamic partial squat position while isometrically contracting quadriceps muscles during each vibration period (60 seconds), keeping knees and hips slightly flexed (20°) with 1 minute rest in between each bout for three days a week for 8 weeks. During treatment, participants will be made to hold hand railing under supervision of a trained physical therapist. Additionally, they will perform upper and lower limb active exercises against gravity with 10 repetitions for all movements on each joint with 2 minutes rest in between. Control group: It will contain subgroups of an equal number of males and females. Control group will be made to perform 10 repetitions of similar dynamic partial squats with same position (knees and hips 20° flexed while isometrically contracting quadriceps muscles) and duration (60 seconds followed by 1-minute rest in between each repetition), three times a week for 8 weeks as in intervention group with vibration platform turned off. During treatment, participants will be made to hold hand railing under supervision of a trained physical therapist. Additionally, they will perform upper and lower limb active exercises against gravity with 10 repetitions for all movements on each joint with 2 minutes rest in between. Skeletal Muscle Index (SMI). Timepoint: before intervention, after intervention and 8 weeks post termination of intervention. Method of measurement: Dual-energy X-ray absorptiometry (DEXA) will be carried out for each participant by the same technician. All assessments will be performed at the same time in the day around 10 a.m. to 12 noon. Muscle strength. Timepoint: before intervention, after intervention and 8 weeks post termination of intervention. Method of measurement: Dynamometer for the hand grip strength and knee strength will be used. For measuring hand grip strength, participant will be asked to squeeze the handle of dynamometer as strongly as possible while three readings will be noted in kilograms from the alternate hand to relax the other hand. After three trials, the highest value of the 3 repetitions will be considered for each hand separately. For measuring maximal isometric strength of knee extensors, the participants will be instructed to sit with their hips and knees at 90 degrees flexion, legs perpendicular to the floor and the feet not touching the ground. The dynamometer will be placed just proximal to the ankle on the front leg. A high density foam pad may be placed between the dynamometer's force pad and the subjects' leg for comfort and to protect subjects' skin. During testing, the subjects will be instructed to contract maximally and to sustain the maximal voluntary contraction for 5 seconds. The highest value of the 3 measurements will be considered. Physical Performance. Timepoint: before intervention, after intervention and 8 weeks post termination of intervention. Method of measurement: Mini Physical Performance Test will be used to measure balance, strength and mobility. It has 4 components: picking up a penny from floor, a timed 50-feet walk, chair rises (5 times) and a progressive Romberg test. Higher scores indicate better performance. Functional mobility. Timepoint: before intervention, after intervention and 8 weeks post termination of intervention. Method of measurement: Timed Up and Go (TUG) will be administered to assess the changes in the functional mobility of the participant's walking. Measuring tape, chair with arm rest, tape to mark the ground and stopwatch will be used in this test. A 3-meter walkway will be measured by the tape. On one end, a chair would be placed facing down the walkway with front legs as the start point of the 3-meter distance. On the other end, a cone will be placed to serve as a marker. The participants will sit on a chair with their back against the back rest preparing for the test. The participant would be signaled to stand up, walk to the marker, turn around once reached to the marker in order to return to the chair and sit again. The time required by the participant to complete the test will be measured. An older adult who would take more than and equal to 12 seconds to complete TUG test will be at risk of falling. Fall risk. Timepoint: before intervention, after intervention and 8 weeks post termination of intervention. Method of measurement: Falls Efficacy Scale-International which is a short, easy to administer tool that measures level of concern about falling during social and physical activities inside and outside the home whether or not the person usually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned) with score of 16 denoting no concern about falling while score of 64 denotes severe concern about falling. Quality of life. Timepoint: before intervention, after intervention and 8 weeks post termination of intervention. Method of measurement: SarQoL questionnaire which is a self-administered questionnaire comprising of 55 items and 22 questions and is organized into 7 domains of health related quality of life (QOL) including Physical and Mental Health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fears. Each domain is scored from 0 (worst QOL) to 100 (best QOL) and overall score is calculated. Inflammatory markers. Timepoint: before intervention, after intervention and 8 weeks post termination of intervention. Method of measurement: Plasma levels will be assessed for each participant in the pathologic lab through blood sample obtained from antecubital vein between 8 a.m. to 10 a.m. Tehran University of Medical Sciences Approved 2023-02-01 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation, Tehran University of Building no. 1, North Door of University, Poursina street, Ghods St, Enghelab Avenue Tehran Tehran Iran (Islamic Republic of)