Variability of Physical Assessments in an Older Population That is Overweight or Obese

Obesity Clinical Trial

Official title:

An Observational Study to Assess the Feasibility and Variability of Physical Assessments Performed by People 45 Years of Age or Older Who Are Overweight or Obese

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05174923
• Other study ID #: VER201-OBS-032
• Status: Completed
• Start date: September 20, 2021
• Est. completion date: November 5, 2021

Study information

• Verified date: December 2021
• Source: Versanis Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Variability of physical assessments in an older population that is overweight or obese.

Description:

The purpose of this study is to understand difficulty in obtaining physical assessment measurements and assess the variability of these assessments when performed by people who are overweight or obese. Data collected in this protocol will be used to inform the design of future clinical studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 5, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

Inclusion Criteria:

• A written informed consent must be obtained before any study-related assessment is conducted.

• Men and women aged = 45.

• BMI = 30 or BMI = 27 with one or more obesity-associated comorbidities (e.g. hypertension, cardiovascular disease, hyperlipidemia, elevated fasting blood sugar levels, sleep apnea).

• Participants must be able to communicate well with the Investigator and comply with the study requirements.

Exclusion Criteria:

• Participant weight > 150 kg.

• Systolic blood pressure < 90 or > 180 or diastolic blood pressure <50 or >100.

• Heart rate = 50 or = 100.

• Unstable medical condition that would put the participant at risk by performing the study assessments.

• Chronic medical condition rendering participants unable to perform the assessment, e.g., severe knee osteoarthritis.

Related Conditions & MeSH terms

• Aging
• Obesity
• Overweight

Intervention

Behavioral:
• Short Performance Physical Battery (SPPB Test)
The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands.
• 30 Second Chair Stand Test (30CST)
The 30CST measures the number of times a person can rise from a seated to standing position within 30 seconds.
• Hand grip dynamometry
Grip strength is used as a marker of overall muscle strength.

Locations

Country	Name	City	State
United States	CNS Healthcare	Jacksonville	Florida
United States	CNS Healthcare	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Versanis Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants.		Baseline (+7 day window)
Primary	To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.		Baseline (+7 day window)
Primary	To assess the variability of grip strength results (kg) with the use of a hand grip dynamometer within and between participants.		Baseline (+7 day window)
Primary	To assess the variability of the individual Short Physical Performance Battery (SPPB) with subsets (subsets of Balance, Gait and Chair Stand scored 0-4) within participants.		Baseline (+7 day window)
Primary	To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.		Baseline (+7 day window)
Primary	To assess the correlation between bioelectrical impedance analysis (BIA) and waist circumference (WC) as well as body mass index (BMI).		Baseline (+7 day window)