Whole- Body Vibration Among Egyptian Elderly With Sarcopenia

NCT06293573 | Active Not Recruiting

• 1 other identifier: 012/005031
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Keywords

Sarcopenia; Elderly; Performance; Whole body vibration; Aerobic exercises

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (3)

whole body vibration group

EXPERIMENTAL

Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style

Device: Whole-body vibration; Other: resistance exercises

aerobic exercise group

EXPERIMENTAL

Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.

Other: aerobic exercises; Other: resistance exercises

conventional resistance exercise group

ACTIVE COMPARATOR

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

Other: resistance exercises

Interventions

Whole-body vibration DEVICE

GROUP A : will receive whole body vibration exercises combined with resistance exercises

Also known as: aerobic exercises - resistance exercises -life style

whole body vibration group

aerobic exercises OTHER

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

aerobic exercise group

resistance exercises OTHER

Group c: will receive progressive resistance exercises with diet modification life style.

aerobic exercise group; conventional resistance exercise group; whole body vibration group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients age older than 60 years
• patients with Skeletal muscle index (SMI) below 8.87 kg/m2 and 6.42 kg/m2 in males and females, respectively.
• patients with hand grip strength below \< 27 kg in men and \< 16 kg in women.
• patients with no regular exercise habit for more than 3 months .
• patients with gait speed \> 0.8 m/s.
• patients with proper conscious and cognition that will be detected by using Mini Mental State Examination(scores \> 21).

You may not qualify if:

• 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.
• inability to walk without assistance. 6-neurological diseases or acute conditions that would interfere with testing and training.
• patients with improper conscious and cognition that will be detected by using Mini Mental State Examination(scores \< 21).
• patients who cannot exercise at all due to conditions like deep vein thrombosis or blood clotting issues.
• 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).
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Dokki, Giza Governorate, 12612, Egypt

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eman A Embaby, phD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be assigned randomly into three groups of equal number (study group A, study group B, and group C) the randomization will be performed by computerized randomization. Assessors will be blinded to the groups of the subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant ecturer

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: January 1, 2024
• Primary Completion: November 29, 2025
• Study Completion: December 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-02

Locations

EG (1)