Whole- Body Vibration Among Egyptian Elderly With Sarcopenia (WBV)

Comparative Effectiveness of Whole- Body Vibration and Aerobic Training Among Egyptian Elderly With Sarcopenia

To investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly.

Study Overview

• Status: Active, not recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Device: Whole-body vibration; Other: resistance exercises; Other: aerobic exercises

Detailed Description

Participants will be assigned randomly into two groups of equal number (study group A and study group B ) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects.

c- Subject selection 84 patients with sarcopenia will participate in this study and will be divided randomly into three equal groups with 28 participants in each group.

d- Groups: Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.

Group C (Control Group): will receive conventional progressive resistance exercises and diet modification life style.

During the study, the participants will receive study information form, instructions and signed the consent form.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12612
      • Faculty of physical therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. patients age older than 60 years
2. patients with Skeletal muscle index (SMI) below 8.87 kg/m2 and 6.42 kg/m2 in males and females, respectively.
3. patients with hand grip strength below < 27 kg in men and < 16 kg in women.
4. patients with no regular exercise habit for more than 3 months .
5. patients with gait speed > 0.8 m/s.

6. patients with proper conscious and cognition that will be detected by using Mini Mental State Examination(scores > 21).

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Exclusion Criteria:

acute injury. 2- severe heart diseases. 3- pacemaker. 4-history of orthopedic surgery of the lower limbs and/or fracture less than 1 year earlier.

.5 - inability to walk without assistance. 6-neurological diseases or acute conditions that would interfere with testing and training.

7-patients with improper conscious and cognition that will be detected by using Mini Mental State Examination(scores < 21).

8- patients who cannot exercise at all due to conditions like deep vein thrombosis or blood clotting issues.

9- patients with severe illnesses that influence assessments and interventions, such as those with disabilities or musculoskeletal conditions (such as fracture, dislocation, osteoporosis, and rheumatoid arthritis).

10- People with major spinal conditions or surgical histories, such as cauda equina syndrome, tumor, vertebral fracture, inflammatory joint disease, spondylolisthesis, and ankylosing spondylitis.

Every participant will get a primary checkup to get a full picture of their health, find out if there are any restrictions, and decide whether they can take part in the study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole body vibration group; Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style	Device: Whole-body vibration; GROUP A : will receive whole body vibration exercises combined with resistance exercises; Other Names: aerobic exercises - resistance exercises -life style; Other: resistance exercises; Group c: will receive progressive resistance exercises with diet modification life style.
Experimental: aerobic exercise group; Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.	Other: resistance exercises; Group c: will receive progressive resistance exercises with diet modification life style.; Other: aerobic exercises; Group B will receive aerobic exercises training combined with progressive resistance exercises with diet modification life style.
Active Comparator: conventional resistance exercise group; Group C (Control Group): will receive conventional progressive resistance exercises and diet modification life style	Other: resistance exercises; Group c: will receive progressive resistance exercises with diet modification life style.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Mass	Outcome measures included: • Skeletal muscle mass (SMM): will be measured by Bioimpedance analysis using body composition analyzer (InBody Dial H 20b).	Muscle mass will be investigated at baseline and after the treatment period of 12 weeks.
muscle strength	will be measured by using calibrated handheld dynamometer (CAMRY EH101).	Muscle strength will be investigated at baseline and after the treatment period of 12 weeks.
timed Up and Go Test (TUG)	The TUG test evaluates physical function, individuals will be asked to rise from a standard chair, walk to a marker 3 m away from the chair, turn around, walk back, and sit down again.	Timed Up and Go Test will be investigated at baseline and after the treatment period of 12 weeks.
Gait Speed test	The 4-m usual walking speed test, which measures speed either manually ,with a stopwatch or instrumentally, with an electronic device, to measure gait timing.	Gait speed test will be investigated at baseline and after the treatment period of 12 weeks.
400 m Walking Test	The 400-meters walk test evaluates a person's stamina and ability to walk. Participants in this test are required to run 20 laps of 20 meters, each lap as quickly as they can, and are permitted up to two rest breaks throughout the test.	400 m Walking Test will be investigated at baseline and after the treatment period of 12 weeks.
Six minute walk test (6MWT)	6MWT is used to measure a patient's exercise tolerance. Also it is used to assess aerobic capacity and endurance. Patient is asked to walk at his normal pace for six minutes.	Six Minutes Walk Test will be investigated at baseline and after the treatment period of 12 weeks.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Eman A Embaby, phD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): November 29, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Performance; Sarcopenia; Aerobic exercises; Whole body vibration
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 012/005031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No