Clinical trial NCT06293573: Whole- Body Vibration Among Egyptian Elderly With Sarcopenia
Official title: Comparative Effectiveness of Whole- Body Vibration and Aerobic Training Among Egyptian Elderly With Sarcopenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Elderly
Performance
Whole body vibration
Aerobic exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 84
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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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Primary outcomes:
measure: Muscle Mass
timeFrame: Muscle mass will be investigated at baseline and after the treatment period of 12 weeks.
measure: muscle strength
timeFrame: Muscle strength will be investigated at baseline and after the treatment period of 12 weeks.
measure: timed Up and Go Test (TUG)
timeFrame: Timed Up and Go Test will be investigated at baseline and after the treatment period of 12 weeks.
measure: Gait Speed test
timeFrame: Gait speed test will be investigated at baseline and after the treatment period of 12 weeks.
measure: 400 m Walking Test
timeFrame: 400 m Walking Test will be investigated at baseline and after the treatment period of 12 weeks.
measure: Six minute walk test (6MWT)
timeFrame: Six Minutes Walk Test will be investigated at baseline and after the treatment period of 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy
state: Giza
Study officials:
affiliation: Cairo University
name: Eman A Embaby, phD
role: STUDY_DIRECTOR
References: