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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06413030
Other study ID # CEC_FP_2023023
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University of Americas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the relationship of gait speed with dynapenic or sarcopenic obesity in community-dwelling older people. The main questions it aims to answer are: - Is slow walking speed related to overweight in older people in the community? - Is slow walking speed related to dynapenic obesity in older people in the community? - Is gait speed related to sarcopenic obesity in older people in the community? Participants will answer a clinical interview to obtain sociodemographic data and will perform the following clinical tests: (1) 10-meter walk test, (2) Anthropometric measurement; (3) Handgrip dynamometry test, (4) Standing dynamometry test and (5) Physical functionality questionnaires.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 383
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Subjects over 60 years of age - Female and male - Self-sufficient in the instrumental activities of daily living - Subjects with or without drug consumption, capable of carrying out the activity of walking independently or dependent on technical aids. Exclusion Criteria: - Subjects with acute musculoskeletal injuries of the lower extremity.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
10 Meter Walk Test
Gait Speed Test

Locations

Country Name City State
Chile Universidad de las Américas Concepción

Sponsors (1)

Lead Sponsor Collaborator
University of Americas

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait Speed A well-lit, unobstructed flat corridor with an extension of 10 meters is used for the test. Ground markings are added at 0 and 10 meters apart, with 2 meters start (acceleration) and 2 meters end (deceleration) added to allow participants room to accelerate and decelerate their walk outside the data collection area to help reduce the gait variability introduced during these phases. Subjects were instructed to walk at a usual and comfortable speed, without running or stopping. Subjects are allowed to use usual technical aids for walking, including walkers or canes if required. Chronometers based on smartphones to time the route between the second and third line of the route that consists of the 10 timed meters. The stopwatch records the time at which the subject's toe crossed the line. This sequence is repeated three times with 1 minute rest periods. The average of the three trials is used to determine the walking speed. Month 1
Primary Anthropometric measures Biospace Inbody: Individuals are placed in a standing position with 30º flexion of the scapulo-humeral joint. 8 electrodes are used located on: feet (metatarso-calcaneus) and hands (metacarpals 2nd-5th finger and phalanx of the thumb). The induction frequency is assessed with 6 different intensities (1, 5, 50, 250, 500 kHz and 1 MHz), with a fat mass estimation sensitivity of 0.1 kg (0.1%). From this measurement we obtain: percentage of muscle mass, percentage of general fat, percentage of visceral fat and bone weight. Month 1
Primary Handgrip dynamometry To evaluate manual muscle strength, the Baseline handgrip dynamometer will be used. The assessment is carried out with the subject in a seated position in a chair without armrests, with the back and feet adequately supported on the floor while the hips and knees are at 90°. The position was with shoulders adducted and neutrally rotated, elbows flexed at 90° and forearms in a neutral position. We began by evaluating the dominant hand by positioning the wrist between 15 and 30° of extension and between 0° and 15° of ulnar deviation. The dynamometer must be used in a vertical position, and parallel to the forearm, while the participant grips the handle with a thumbs up. 3 repetitions were performed for each limb, obtaining an average of the measurements, the grip time will be 3 to 6 seconds with a rest time of 1 minute, using the best value for data analysis. Month 1
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