Motor ActivityNCT03753295
The Effect of BMI on Hand Grip Force in Healthy Adults
An observational study of Motor Activity and Overweight and Obesity, run by Wafaa Mahmoud Amin at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 25 years
- Conditions the study is for
- Motor Activity, Overweight and Obesity, Hand Injuries
- What is being tested?
- Hand Grip Force
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Dec 2018to 10 Jan 2019
- Phase
- Observational
- 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 19 to 25 years
- All sexes
- Adult
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.
Who may be able to join
- Subjects would not have any diseases of the central nervous system.
- Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.
- None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .
Who cannot join
- Sign of foot pain, reduced tactile and thermal foot sensibility.
- Peripheral neuropathy.
- A history of previous back or abdominal surgery/injury
- A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .
- Limb-length discrepancy, and anterior or posterior tibialis dysfunction.
- Evidence of a systemic or musculoskeletal disease within the past six months (AlAbdulwahab \& Kachanathu, 2016).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Motor Activity, Overweight and Obesity, Hand Injuries
- Being tested
- Hand Grip Force
- Keywords
- BMI, Hand Grip, Healthy Adults
- Medical subject headings
- Motor Activity, Overweight, Obesity, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Grip ForceDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Hand Grip Force | |
| 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. Receives: Diagnostic Test: Hand Grip Force | |
| 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. Receives: Diagnostic Test: Hand Grip Force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Force of the Right Dominant Hand in The Three Groups
Hand Grip strength will be measured in three groups and comparison between them will be made
Measured: 10 minutes
Comparison of Hand Grip Force between Both Arms in three Groups
Measurement of both right dominant hand and left hand will be measured in the three groups and compared with each other.
Measured: 20 minutes
Secondary outcomes (1)
the effect of gender on the hand grip
measurement of hand grip force of the right dominant hand will be taken for both male and females in the three subjects
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start2 Dec 2018
- Primary completion3 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wafaa Mahmoud Amin
- Sponsor type
- Other government
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Wafaa Mahmoud Amin, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753295
- Sponsor's protocol ID
- 27704112500
- Status last verified
- Mar 2019
- First submitted
- 23 Nov 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BMI on Hand Grip Force in Healthy Adults
- ClinicalTrials.gov ID
- NCT03753295
- Acronym / sponsor ID
- 27704112500
- Conditions
- Motor Activity, Overweight and Obesity, Hand Injuries
- Keywords
- BMI, Hand Grip, Healthy Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wafaa Mahmoud AminOther government
- Collaborators
- Cairo University
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 26 Nov 2018 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (normal subjects) | – | Diagnostic Test: Hand Grip Force30 individuals (15 male, and 15 female students) with (BMI<25 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer. |
| Group II (overweight subjects) | – | Diagnostic Test: Hand Grip Force30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer. |
| Group III (obese subjects) | – | Diagnostic Test: Hand Grip Force30 individuals (15 male, and 15 female students) (BMI>30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Subjects would not have any diseases of the central nervous system.
- Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.
- None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .
Key exclusion criteria (6 listed)
- Sign of foot pain, reduced tactile and thermal foot sensibility.
- Peripheral neuropathy.
- A history of previous back or abdominal surgery/injury
- A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .
- Limb-length discrepancy, and anterior or posterior tibialis dysfunction.
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 |
|---|---|---|
| Hand Grip ForceFor 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 | Diagnostic test | Group I (normal subjects), Group II (overweight subjects), Group III (obese subjects) |
Primary outcome
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
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.
1 secondary outcome
the effect of gender on the hand grip
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Activity and Overweight and Obesity, run by Wafaa Mahmoud Amin at 1 site in Saudi Arabia.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 12 Mar 2019. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hand Grip Force of the Right Dominant Hand in The Three Groups (time frame: 10 minutes). The study lists 2 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 12 Mar 2019.