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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05060874
Other study ID # 2021-A00927-34
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date November 18, 2021

Study information

Verified date November 2021
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is recommended to screen ageing patients for sarcopenia, due to the increased risk of morbimortality if detected positive. According to the consensus of the European Working Group on Sarcopenia in Older People, the diagnosis of sarcopenia is based, among other things, on grip strength measurement. Our study will compare the performance of the new GRIPWISE digital device with the mechanical dynamometer JAMAR, the gold standard currently used to assess the grip strength. We propose to evaluate it in an elderly hospitalized population where the prevalence of sarcopenia is likely to be high due to the high prevalence of various chronic illness, notably oncological and cardiological ones. This cross-sectional study will include 348 patients.


Recruitment information / eligibility

Status Completed
Enrollment 348
Est. completion date November 18, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - men and women aged 65 or over - affiliated to a health insurance - Francophone. Exclusion Criteria: - - refusal to participate - unable to communicate - unable to use both hands (dominant and non-dominant)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Caen University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison between Jamar® and Gripwise® values for grip strength measurement Intra-class correlation between the best values obtained with each device day1
Secondary comparison according to the patient's position correlations of dynamometer measurements between patients assessed in the sitting or lying position day1
Secondary number of attempt to reach the maximum value Comparison of the three measurements obtained for each patient with each device day1
Secondary factors influencing detected weakness significant difference in the rate of women detected as weak with a handgrip <16kg and men <27kg, between the different reasons for hospitalisation, the number of days of hospitalisation, and between the different chronic cancerous and non-cancerous pathologies (Updated Charlson Comorbidity Index), the age groups 65-79 years and =80 years day1
Secondary satisfaction using the devices rate of patients finding one of both device easier to use day1
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