Whole- Body Vibration Among Egyptian Elderly With Sarcopenia

Sarcopenia Clinical Trial

— WBV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06293573
• Other study ID #: 012/005031
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 1, 2025
• Est. primary completion date: November 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Sarcopenia

Intervention

Device:
• Whole-body vibration
GROUP A : will receive whole body vibration exercises combined with resistance exercises

Other:
• aerobic exercises
Group B will receive aerobic exercises training combined with progressive resistance exercises with diet modification life style.
• resistance exercises
Group c: will receive progressive resistance exercises with diet modification life style.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Dokki	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.