SarcopeniaWBVNCT06293573
Whole- Body Vibration Among Egyptian Elderly With Sarcopenia
A study testing Whole-body vibration, aerobic exercises and resistance exercises in people with Sarcopenia, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Whole-body vibration, aerobic exercises and resistance exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Whole-body vibration, aerobic exercises, resistance exercises
- Keywords
- Sarcopenia, Elderly, Performance, Whole body vibration, Aerobic exercises
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibrationDevice
Also called aerobic exercises - resistance exercises -life style
GROUP A : will receive whole body vibration exercises combined with resistance exercises
aerobic exercisesOther
Group B will receive aerobic exercises training combined with progressive resistance exercises with diet modification life style.
resistance exercisesOther
Group c: will receive progressive resistance exercises with diet modification life style.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass
Outcome measures included:
- Skeletal muscle mass (SMM): will be measured by Bioimpedance analysis using body composition analyzer (InBody Dial H 20b).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six Minutes Walk Test will be investigated at baseline and after the treatment period of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jan 2024
- Primary completion29 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hussien Abdelmotaal Ali Elkadi, Cairo University
- Investigators
- Eman A Embaby, phD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293573
- Sponsor's protocol ID
- 012/005031
- Acronym
- WBV
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Whole- Body Vibration and Aerobic Training Among Egyptian Elderly With Sarcopenia
- ClinicalTrials.gov ID
- NCT06293573
- Acronym / sponsor ID
- WBV / 012/005031
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Elderly, Performance, Whole body vibration, Aerobic exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 29 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| whole body vibration group | Experimental | Device: Whole-body vibration, Other: resistance exercisesGroup A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style |
| aerobic exercise group | Experimental | Other: aerobic exercises, Other: resistance exercisesGroup B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style. |
| conventional resistance exercise group | Active comparator | Other: resistance exercisesGroup C (Control Group): will receive conventional progressive resistance exercises and diet modification life style |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body vibrationAlso: aerobic exercises - resistance exercises -life styleGROUP A : will receive whole body vibration exercises combined with resistance exercises | Device | whole body vibration group |
| aerobic exercisesGroup B will receive aerobic exercises training combined with progressive resistance exercises with diet modification life style. | Other | aerobic exercise group |
| resistance exercisesGroup c: will receive progressive resistance exercises with diet modification life style. | Other | aerobic exercise group, conventional resistance exercise group, whole body vibration group |
Primary outcome
Muscle Mass
Time frame: Muscle mass will be investigated at baseline and after the treatment period of 12 weeks.
Outcome measures included: • Skeletal muscle mass (SMM): will be measured by Bioimpedance analysis using body composition analyzer (InBody Dial H 20b).
muscle strength
Time frame: Muscle strength will be investigated at baseline and after the treatment period of 12 weeks.
will be measured by using calibrated handheld dynamometer (CAMRY EH101).
timed Up and Go Test (TUG)
Time frame: Timed Up and Go Test will be investigated at baseline and after the treatment period of 12 weeks.
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.
Gait Speed test
Time frame: Gait speed test will be investigated at baseline and after the treatment period of 12 weeks.
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.
400 m Walking Test
Time frame: 400 m Walking Test will be investigated at baseline and after the treatment period of 12 weeks.
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.
Six minute walk test (6MWT)
Time frame: Six Minutes Walk Test will be investigated at baseline and after the treatment period of 12 weeks.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman A Embaby, phD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body vibration, aerobic exercises and resistance exercises in people with Sarcopenia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Mass (time frame: Muscle mass will be investigated at baseline and after the treatment period of 12 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.