Relative Hand Grip Strength and Functional Fitness in Diabetic Patient in Egypt

October 15, 2024 updated by: Mohammed Youssef Elhamrawy, Beni-Suef University

Relative Hand Grip Strength and Functional Fitness Among Elderly Patients with Type II Diabetes in Egypt: a Cross-sectional Study

To show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old.

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

To show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old.

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 (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.
200

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
      • Cairo, Egypt
        • Kz hospital
    • Elgharbia
      • Cairo, Elgharbia, Egypt, 31611
        • Kz hospital

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Diabetes type II
  • Ability to walk independently
  • The cognitive and mental capacity to understand and perform tests

Exclusion Criteria:

  • Musculoskeletal, neurological, rheumatological problems, or hand deformities that could hinder grasping

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: Diabetic group
100 randomly selected older adults with DM II, of both sexes who are attending endocrine outpatient clinics in governmental hospitals.
Diagnostic test: relative Hand grip strength
To perform this study the relative handgrip strength (rHGS) index was used. The rHGSi is defined as the sum of the handgrip strength of both hands divided by body mass index (BMI), and it is considered a better prognostic tool than handgrip strength. rHGS was measured by Jamar hand dynamometer. The Functional Performance was determined by using 3 tests of the Senior Fitness Test (The 30-second chair stand test, the 8-feet Up-and-Go test, and the 2 minutes' Walk Test).
Diagnostic test: senior fitness test
The Functional Performance was determined by using 3 tests of the Senior Fitness Test (The 30-second chair stand test, the 8-feet Up-and-Go test, and the 2 minutes' Walk Test).
Active Comparator: non diabetic group
100 older adults non diabetic, of both sexes who are attending endocrine outpatient clinics in governmental hospitals.
Diagnostic test: relative Hand grip strength
To perform this study the relative handgrip strength (rHGS) index was used. The rHGSi is defined as the sum of the handgrip strength of both hands divided by body mass index (BMI), and it is considered a better prognostic tool than handgrip strength. rHGS was measured by Jamar hand dynamometer. The Functional Performance was determined by using 3 tests of the Senior Fitness Test (The 30-second chair stand test, the 8-feet Up-and-Go test, and the 2 minutes' Walk Test).
Diagnostic test: senior fitness test
The Functional Performance was determined by using 3 tests of the Senior Fitness Test (The 30-second chair stand test, the 8-feet Up-and-Go test, and the 2 minutes' Walk Test).

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
relative Hand grip strength
Time Frame: Baseline
the sum of the handgrip strength of both hands divided by body mass index (BMI)
Baseline
The 30-Second Chair Test
Time Frame: Baseline
The 30-Second Chair Test is a standing exercise where participants sit in a folding chair without arms, with their feet shoulder-width apart and arms crossed. The test requires the participant to perform full stands within 30 seconds, with the goal of completing the task without using their arms.
Baseline
8-feet Up-and-Go test
Time Frame: Baseline
Place a chair and marker 8 feet apart, clear the path, and start seated. Start timing, then quickly stand, walk, and walk around a cone, returning to the chair. Stop timing as needed. Perform two trials.
Baseline
2 min walk test
Time Frame: Baseline
For two minutes, the person is urged to walk as quickly as they can while remaining safe and independent, and the distance is recorded.
Baseline

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.
Beni-Suef 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.
  • Principal Investigator: Mohammed Yo Elhamrawy, National institute for Gerontology

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.
October 15, 2023

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.
October 5, 2024

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.
October 5, 2024

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).
October 12, 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.
October 15, 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.
October 16, 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.
October 16, 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.
October 15, 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.
October 1, 2024

More Information

Terms related to this study

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.
  • Hand Grip

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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