Slow Gait Speed as an Indicator of Overweight, Dynapenic Obesity and Sarcopenic Obesity in Elderly People in the Community (SGSF)

May 13, 2024 updated by: Karen Córdova-León, University of Americas

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

Enrolling by invitation

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

383

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Concepción, Chile
        • Universidad de las Américas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Older people who live in the community and attend primary health care centers in the Bio Bio Region of Chile.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Gait Speed Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Speed
Time Frame: Month 1
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
Anthropometric measures
Time Frame: Month 1
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
Handgrip dynamometry
Time Frame: Month 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen Córdova-León, PT, Academic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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