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

Completed

• Conditions: Obesity; Aging
• Interventions: Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry

• Registration Number: NCT05174923
• Lead Sponsor: Versanis Bio, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-09-20
• Primary Completion: 2021-11-05
• Study Completion: 2021-11-05
• Study First Submitted: 2021-11-05
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-13
• Last Update Submitted: 2021-12-13
• Study First Posted: 2022-01-03
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age >/= 76	Short Performance Physical Battery (SPPB Test)	-
Age Range 45 to </= 60	30 Second Chair Stand Test (30CST)	-
Age Range 61 to </= 75	Hand grip dynamometry	-
Age >/= 76	30 Second Chair Stand Test (30CST)	-
Age Range 61 to </= 75	30 Second Chair Stand Test (30CST)	-
Age Range 45 to </= 60	Short Performance Physical Battery (SPPB Test)	-
Age Range 45 to </= 60	Hand grip dynamometry	-
Age Range 61 to </= 75	Short Performance Physical Battery (SPPB Test)	-
Age >/= 76	Hand grip dynamometry	-

Primary Outcome Measures

Name	Time	Method
To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.	Baseline (+7 day window)
To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.	Baseline (+7 day window)
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)
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)
To assess the correlation between bioelectrical impedance analysis (BIA) and waist circumference (WC) as well as body mass index (BMI).	Baseline (+7 day window)
To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants.	Baseline (+7 day window)

Trial Locations

Locations (1)

CNS Healthcare; 🇺🇸 Orlando, Florida, United States