- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413030
Slow Gait Speed as an Indicator of Overweight, Dynapenic Obesity and Sarcopenic Obesity in Elderly People in the Community (SGSF)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Concepción, Chile
- Universidad de las Américas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Community-dwelling older adults
Persons over 60 years of age attending primary health care centers in the Bio Bio Region of Chile.
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Gait Speed Test
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait Speed
Time Frame: Month 1
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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.
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Month 1
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Anthropometric measures
Time Frame: Month 1
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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.
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Month 1
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Handgrip dynamometry
Time Frame: Month 1
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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.
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Month 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Córdova-León, PT, Academic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEC_FP_2023023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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