Whole- Body Vibration Among Egyptian Elderly With Sarcopenia

NCT ID: NCT06293573

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-01

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.

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

whole body vibration group

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

Group Type: EXPERIMENTAL

Whole-body vibration

Intervention Type: DEVICE

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

resistance exercises

Intervention Type: OTHER

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

aerobic exercise group

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

Group Type: EXPERIMENTAL

aerobic exercises

Intervention Type: OTHER

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

resistance exercises

Intervention Type: OTHER

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

conventional resistance exercise group

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

Group Type: ACTIVE_COMPARATOR

resistance exercises

Intervention Type: OTHER

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

Interventions

Whole-body vibration

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

Intervention Type: DEVICE

aerobic exercises

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

Intervention Type: OTHER

resistance exercises

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

Intervention Type: OTHER

Other Intervention Names

aerobic exercises - resistance exercises -life style

Eligibility Criteria

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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• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hussien Abdelmotaal Ali Elkadi

Assistant ecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman A Embaby, phD

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of Physical Therapy

Dokki, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

012/005031

Identifier Type: -

Identifier Source: org_study_id