Whole- Body Vibration Among Egyptian Elderly With Sarcopenia (WBV)

February 27, 2024 updated by: Ahmed Hussien Abdelmotaal Ali Elkadi, Cairo University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt, 12612
        • Faculty of physical therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

    -

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: whole body vibration group
Group A (Study group): Will receive whole body vibration exercises with conventional progressive resistance exercises and diet modification life style
Device: Whole-body vibration
GROUP A : will receive whole body vibration exercises combined with resistance exercises
Other Names:
  • aerobic exercises - resistance exercises -life style
Other: resistance exercises
Group c: will receive progressive resistance exercises with diet modification life style.
Experimental: aerobic exercise group
Group B (Study group): Will receive aerobic exercises training with conventional progressive resistance exercises and diet modification life style.
Other: resistance exercises
Group c: will receive progressive resistance exercises with diet modification life style.
Other: aerobic exercises
Group B will receive aerobic exercises training combined with progressive resistance exercises with diet modification life style.
Active Comparator: conventional resistance exercise group
Group C (Control Group): will receive conventional progressive resistance exercises and diet modification life style
Other: resistance exercises
Group c: will receive progressive resistance exercises with diet modification life style.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 mass will be investigated at baseline and after the treatment period of 12 weeks.
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).
Muscle strength will be investigated at baseline and after the treatment period of 12 weeks.
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.
Timed Up and Go Test will be investigated at baseline and after the treatment period of 12 weeks.
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.
Gait speed test will be investigated at baseline and after the treatment period of 12 weeks.
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.
400 m Walking Test will be investigated at baseline and after the treatment period of 12 weeks.
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.
Six Minutes Walk Test will be investigated at baseline and after the treatment period of 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eman A Embaby, phD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 012/005031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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