Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623019
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Study of the Validity and Reliability of Two Digital Dynamometers in Older People
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of the Validity and Reliability of Two Digital Dynamometers in Older People
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOVARDDIOP
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 adultsThe 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 090 With an estimated ICC of 090 005 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 005 and IBM SPSS Statistics v280 will be used for analysis
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 090 With an estimated ICC of 090 005 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 005 and IBM SPSS Statistics v280 will be used for analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None