SarcopeniaSOVARDDIOPNCT06623019
Study of the Validity and Reliability of Two Digital Dynamometers in Older People
An observational study of Sarcopenia and Old Age; Debility, run by University of Salamanca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Old Age; Debility, Frailty
- What is being tested?
- Validation and reliability
- How many people
- 413 participants
- Where
- 1 siteSpain
- Study dates
- 16 Dec 2024to 15 Apr 2025
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling older adults of both sexes over 60 years of age.
Who may be able to join
- Community-dwelling older adults of both sexes over 60 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Design: 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 the Device 1 and Device 2 devices in measuring grip strength and muscle fatigability in community-dwelling older adults.
It will be carried out in two stages: In a first moment the criterion and interobserver validity will be assessed and in a second moment the intraobserver validity. Participants will be randomly assigned to one of the 6 arms to follow different orders of the devices (Device 1, Device 2 or Jamar).
Population: community-dwelling older adults of both sexes over 60 years of age.
Procedures: The investigators will schedule each participant for the initial assessment day. Using a table of random numbers, they will be assigned one of the arms. All participants have previously read, signed and given their written informed consent. An interview will be conducted in which age, sex and medication will be collected; an anthropometric and functional assessment will be performed. The functional tests include the 30-second squat test and grip strength tests using the Jamar, Device 1 and Device 2. Three repetitions will be performed with each device, allowing 30 seconds between repetitions and 3 to 5 minutes between devices. After 20 minutes the test will be repeated again on the devices for interobserver validation. 5 to 10 days later, tester 1 will repeat the grip test with the same effort to assess intraobserver reliability.
Sample size: Similar studies validating grip strength devices compared to the Jamar showed an excellent correlation (ICC > 0.90). With an estimated ICC of 0.90 ± 0.05 and an alpha risk of 5%, 348 participants are required for the training study.
Variables: Sociodemographic (age, sex, hand dominance, number of medication types), anthropometric (height, weight, BMI and SMI), strength and fatigability (total number of repetitions in 30sCS, maximal grip strength (HGS), fatigue resistance (FR) and grip work (GW)) and device preference.
Statistical analysis: Maximal strength and fatigability will be analyzed by means of means, standard deviations and statistical tests. Concordance between devices will be assessed using the Kappa coefficient and the Bland-Altman concordance index. ROC curves will be used to determine sensitivity and specificity, and data will be analyzed by gender. Results will be considered statistically significant if p < 0.05, and IBM SPSS Statistics v28.0 will be used for analysis.
- Conditions
- Sarcopenia, Old Age; Debility, Frailty
- Being tested
- Validation and reliability
- Keywords
- Muscle Strength Dynamometer, Hand Strength, aged, Muscle Fatigue, Jamar
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation and reliabilityDiagnostic test
As this is a cross-sectional validation study, there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Validation and reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
2. Hand grip test
Measurement of hand grip strength using a hand-held dynamometer. Values shall be recorded with all three devices.
Measured: 2 weeks
Secondary outcomes (5)
Body Mass Index (BMI)
Is a mathematical ratio that associates the mass and the size of an individual BMI = weight / height ^2
Measured: 2 weeks
4. Appendicular Skeletal Muscle mass Index (SMI)
Is a mathematical ratio that associates the muscle mass and the size of an individual SMI = appendicular muscle mass / height ^2
Measured: 2 weeks
30 seconds chair stand test (30sCS)
Test that measures the number of times you perform the maximum number of squats on a chair in 30 seconds. The more squats the better functionally.
Measured: 2 weeks
Fatigue resistance (FR)
Time taken to lose 50% of the maximum recorded grip strength.
Measured: 2 weeks
Grip work (GW)
Value resulting from multiplying the maximum grip force by the fatigue strength by 0,75. It is measured in watts.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start16 Dec 2024
- Primary completion31 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Polo Ferrero, University of Salamanca
- Investigators
- Luis Polo-Ferrero, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623019
- Sponsor's protocol ID
- USalamancaValidityDinamometers
- Acronym
- SOVARDDIOP
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Jun;17(3):1169-1179. doi: 10.1007/s41999-025-01403-9. Epub 2026 Feb 26.
PubMed 41746539
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Validity and Reliability of Two Digital Dynamometers in Older People
- ClinicalTrials.gov ID
- NCT06623019
- Acronym / sponsor ID
- SOVARDDIOP / USalamancaValidityDinamometers
- Conditions
- Sarcopenia, Old Age; Debility, Frailty
- Keywords
- Muscle Strength Dynamometer, Hand Strength, aged, Muscle Fatigue, Jamar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 2 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.
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.
Detailed description
Design: 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 the Device 1 and Device 2 devices in measuring grip strength and muscle fatigability in community-dwelling older adults.
It will be carried out in two stages: In a first moment the criterion and interobserver validity will be assessed and in a second moment the intraobserver validity. Participants will be randomly assigned to one of the 6 arms to follow different orders of the devices (Device 1, Device 2 or Jamar).
Population: community-dwelling older adults of both sexes over 60 years of age.
Procedures: The investigators will schedule each participant for the initial assessment day. Using a table of random numbers, they will be assigned one of the arms. All participants have previously read, signed and given their written informed consent. An interview will be conducted in which age, sex and medication will be collected; an anthropometric and functional assessment will be performed. The functional tests include the 30-second squat test and grip strength tests using the Jamar, Device 1 and Device 2. Three repetitions will be performed with each device, allowing 30 seconds between repetitions and 3 to 5 minutes between devices. After 20 minutes the test will be repeated again on the devices for interobserver validation. 5 to 10 days later, tester 1 will repeat the grip test with the same effort to assess intraobserver reliability.
Sample size: Similar studies validating grip strength devices compared to the Jamar showed an excellent correlation (ICC > 0.90). With an estimated ICC of 0.90 ± 0.05 and an alpha risk of 5%, 348 participants are required for the training study.
Variables: Sociodemographic (age, sex, hand dominance, number of medication types), anthropometric (height, weight, BMI and SMI), strength and fatigability (total number of repetitions in 30sCS, maximal grip strength (HGS), fatigue resistance (FR) and grip work (GW)) and device preference.
Statistical analysis: Maximal strength and fatigability will be analyzed by means of means, standard deviations and statistical tests. Concordance between devices will be assessed using the Kappa coefficient and the Bland-Altman concordance index. ROC curves will be used to determine sensitivity and specificity, and data will be analyzed by gender. Results will be considered statistically significant if p < 0.05, and IBM SPSS Statistics v28.0 will be used for analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device 1, Device 2 and Jamar® | – | Diagnostic Test: Validation and reliabilityAs 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults of both sexes over 60 years of age.
Key inclusion criteria (1 listed)
- Community-dwelling older adults of both sexes over 60 years of age.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Validation and reliabilityAs this is a cross-sectional validation study, there is no intervention. | Diagnostic test | Device 1, Device 2 and Jamar® |
Primary outcome
2. Hand grip test
Time frame: 2 weeks
Measurement of hand grip strength using a hand-held dynamometer. Values shall be recorded with all three devices.
5 secondary outcomes
Body Mass Index (BMI)
Time frame: 2 weeks
4. Appendicular Skeletal Muscle mass Index (SMI)
Time frame: 2 weeks
30 seconds chair stand test (30sCS)
Time frame: 2 weeks
Fatigue resistance (FR)
Time frame: 2 weeks
Grip work (GW)
Time frame: 2 weeks
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 18 Dec 2025.
- Derived from this study: PubMed 41746539Polo-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 Jun;17(3):1169-1179. doi: 10.1007/s41999-025-01403-9. Epub 2026 Feb 26.
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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.
Luis Polo-Ferrero, PhD principal investigator
University of Salamanca
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 Sarcopenia and Old Age; Debility, run by University of Salamanca at 1 site in Spain.
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 1 inclusion and 5 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 18 Dec 2025. 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 Spain. 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?
2. Hand grip test (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623019, which also lists 1 linked publication.
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 18 Dec 2025.