Type II Diabetes MellitusNCT06645418
Relative Hand Grip Strength and Functional Fitness in Diabetic Patient in Egypt
A study testing relative Hand grip strength and senior fitness test in people with Type II Diabetes Mellitus, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
To show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- relative Hand grip strength and senior fitness test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Oct 2023to 5 Oct 2024
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Diabetes type II
- Ability to walk independently
- The cognitive and mental capacity to understand and perform tests
Who cannot join
- Musculoskeletal, neurological, rheumatological problems, or hand deformities that could hinder grasping
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- relative Hand grip strength, senior fitness test
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relative Hand grip strengthDiagnostic test
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).
senior fitness testDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Diabetic group | Active comparator | 100 randomly selected older adults with DM II, of both sexes who are attending endocrine outpatient clinics in governmental hospitals. Receives: Diagnostic Test: relative Hand grip strength; Diagnostic Test: senior fitness test |
| non diabetic group | Active comparator | 100 older adults non diabetic, of both sexes who are attending endocrine outpatient clinics in governmental hospitals. Receives: Diagnostic Test: relative Hand grip strength; Diagnostic Test: senior fitness test |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative Hand grip strength
the sum of the handgrip strength of both hands divided by body mass index (BMI)
Measured: Baseline
The 30-Second Chair Test
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.
Measured: Baseline
8-feet Up-and-Go test
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.
Measured: Baseline
2 min walk test
For two minutes, the person is urged to walk as quickly as they can while remaining safe and independent, and the distance is recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start15 Oct 2023
- Primary completion5 Oct 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Youssef Elhamrawy, Beni-Suef University
- Investigators
- Mohammed Yo Elhamrawy, Principal investigator, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645418
- Sponsor's protocol ID
- Hand Grip
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Hand Grip Strength and Functional Fitness Among Elderly Patients with Type II Diabetes in Egypt: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06645418
- Acronym / sponsor ID
- Hand Grip
- Conditions
- Type II Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 16 Oct 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 show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic group | Active comparator | Diagnostic Test: relative Hand grip strength, Diagnostic Test: senior fitness test100 randomly selected older adults with DM II, of both sexes who are attending endocrine outpatient clinics in governmental hospitals. |
| non diabetic group | Active comparator | Diagnostic Test: relative Hand grip strength, Diagnostic Test: senior fitness test100 older adults non diabetic, of both sexes who are attending endocrine outpatient clinics in governmental hospitals. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Diabetes type II
- Ability to walk independently
- The cognitive and mental capacity to understand and perform tests
Key exclusion criteria (1 listed)
- Musculoskeletal, neurological, rheumatological problems, or hand deformities that could hinder grasping
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 |
|---|---|---|
| relative Hand grip strengthTo 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 | Diabetic group, non diabetic group |
| senior fitness testThe 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 | Diabetic group, non diabetic group |
Primary outcome
relative Hand grip strength
Time frame: Baseline
the sum of the handgrip strength of both hands divided by body mass index (BMI)
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.
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.
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.
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 16 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Mohammed Yo Elhamrawy principal investigator
National institute for Gerontology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relative Hand grip strength and senior fitness test in people with Type II Diabetes Mellitus, run by Beni-Suef University at 2 sites 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 3 inclusion and 1 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
relative Hand grip strength (time frame: Baseline). The study lists 4 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 16 Oct 2024.