NCT06623019

Brief Summary

It is a cross-sectional, randomized, and single-center study with a duration of 6 months. The study will follow the STROBE guidelines for cross-sectional studies and CONSORT 2024. The main objective is to evaluate the validity and reliability of two devices in measuring grip strength and muscle fatigability in community-dwelling older adults.The study will include community-dwelling older adults of both sexes over 60 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
413

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 16, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

September 19, 2024

Last Update Submit

December 10, 2025

Conditions

Keywords

Muscle Strength DynamometerHand StrengthagedMuscle FatigueJamar

Outcome Measures

Primary Outcomes (1)

  • 2. Hand grip test

    Measurement of hand grip strength using a hand-held dynamometer. Values shall be recorded with all three devices.

    2 weeks

Secondary Outcomes (5)

  • Body Mass Index (BMI)

    2 weeks

  • 4. Appendicular Skeletal Muscle mass Index (SMI)

    2 weeks

  • 30 seconds chair stand test (30sCS)

    2 weeks

  • Fatigue resistance (FR)

    2 weeks

  • Grip work (GW)

    2 weeks

Study Arms (1)

Device 1, Device 2 and Jamar®

As this is a validation study, both criterion, inter-observer and intra-observer validation will be performed. Initially, three repetitions will be performed with each device, leaving between 3 and 5 minutes of rest between devices. 20-30 minutes later, the same process will be repeated but with another researcher giving the orders (interobserver reliability). A few days later the same process is repeated with the first investigator (intra-observer reliability). No person will receive any treatment.

Diagnostic Test: Validation and reliability

Interventions

As this is a cross-sectional validation study, there is no intervention.

Device 1, Device 2 and Jamar®

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling older adults of both sexes over 60 years of age.

You may qualify if:

  • Community-dwelling older adults of both sexes over 60 years of age.

You may not qualify if:

  • Those who do not understand the orders given to them by the researcher or present an obvious advanced state of dementia.
  • Those people who have amputation in one of the two upper limbs or who cannot perform manual grasping for any reason.
  • Those who have had an episode of pain in one of the hands during the week prior to the measurement.
  • Those who, due to any illness, prevent or contraindicate maximum resistance exercises.
  • Any other cause that the research team assesses that may affect the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Related Publications (1)

  • Polo-Ferrero L, Mendez-Sanchez R, Martin-Vallejo J, Torres-Alonso J, Carrera-Villegas MB, Barbero-Iglesias FJ, Cruz-Jentoft AJ, Montero-Errasquin B. Validity, reliability, and diagnostic accuracy of the InGrip digital dynamometer compared with the Jamar hydraulic model in older adults. Eur Geriatr Med. 2026 Feb 26. doi: 10.1007/s41999-025-01403-9. Online ahead of print.

MeSH Terms

Conditions

SarcopeniaFrailty

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Luis Polo-Ferrero, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2024

First Posted

October 2, 2024

Study Start

December 16, 2024

Primary Completion

March 31, 2025

Study Completion

April 15, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations