The Effect of BMI on Hand Grip Force in Healthy Adults

March 10, 2019 updated by: Wafaa Mahmoud Amin
This study will be conducted to investigate the effect of BMI on hand grip force in healthy subjects. The participants in this study will be 90 healthy subjects with right dominant lower limb (49 females and 49 males) they will be recruited from College of Applied Medical Sciences, Jazan University.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Subjects will be categorized according to BMI into three groups:

Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI<25 kg/m2) Group II (overweight subjects): 30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2).

Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI>30 kg/m2).

Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New York, USA) will be used to measure the hand grip strength and pinch strength

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.
Observational

Enrollment (Actual)

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.
90

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

  • Saudi Arabia
    • Jazan
      • Riyadh, Jazan, Saudi Arabia, 45142
        • Jazan University

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

15 years to 21 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

90 healthy male and female students with age 19 to 25 years old, and right dominant hand, will be recruited from the College of Applied Medical Sciences, Jazan University.

Description

Inclusion Criteria:

  1. Subjects would not have any diseases of the central nervous system.
  2. Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.
  3. None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .

Exclusion Criteria:

  1. Sign of foot pain, reduced tactile and thermal foot sensibility.
  2. Peripheral neuropathy.
  3. A history of previous back or abdominal surgery/injury
  4. A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .
  5. Limb-length discrepancy, and anterior or posterior tibialis dysfunction.
  6. Evidence of a systemic or musculoskeletal disease within the past six months (AlAbdulwahab & Kachanathu, 2016).

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group I (normal subjects)
30 individuals (15 male, and 15 female students) with (BMI<25 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.
Diagnostic test: Hand Grip Force

For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.

The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.

The test will be performed twice, and the higher value between the two measurements will be selected.

The subjects will be allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress
Group II (overweight subjects)
30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.
Diagnostic test: Hand Grip Force

For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.

The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.

The test will be performed twice, and the higher value between the two measurements will be selected.

The subjects will be allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress
Group III (obese subjects)
30 individuals (15 male, and 15 female students) (BMI>30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.
Diagnostic test: Hand Grip Force

For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.

The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.

The test will be performed twice, and the higher value between the two measurements will be selected.

The subjects will be allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress

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
Hand Grip Force of the Right Dominant Hand in The Three Groups
Time Frame: 10 minutes
Hand Grip strength will be measured in three groups and comparison between them will be made
10 minutes
Comparison of Hand Grip Force between Both Arms in three Groups
Time Frame: 20 minutes
Measurement of both right dominant hand and left hand will be measured in the three groups and compared with each other.
20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the effect of gender on the hand grip
Time Frame: 10 minutes
measurement of hand grip force of the right dominant hand will be taken for both male and females in the three subjects
10 minutes

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.
Wafaa Mahmoud Amin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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.
December 2, 2018

Primary Completion (Actual)

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.
January 3, 2019

Study Completion (Actual)

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.
January 10, 2019

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).
November 23, 2018

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.
November 23, 2018

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.
November 26, 2018

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 12, 2019

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.
March 10, 2019

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.
March 1, 2019

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.
  • 27704112500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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