NCT06645418

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

October 12, 2024

Last Update Submit

October 15, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • relative Hand grip strength

    the sum of the handgrip strength of both hands divided by body mass index (BMI)

    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.

    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.

    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.

    Baseline

Study Arms (2)

Diabetic group

ACTIVE COMPARATOR

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 strengthDiagnostic 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.

Diagnostic Test: relative Hand grip strengthDiagnostic Test: senior fitness test

Interventions

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).

Diabetic groupnon diabetic group
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).

Diabetic groupnon diabetic group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kz hospital

Cairo, Elgharbia, 31611, Egypt

Location

Kz Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mohammed Yo Elhamrawy

    National institute for Gerontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical therapy

Study Record Dates

First Submitted

October 12, 2024

First Posted

October 16, 2024

Study Start

October 15, 2023

Primary Completion

October 5, 2024

Study Completion

October 5, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations