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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Aging
• Intervention / Treatment: Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • CNS Healthcare
    • Orlando, Florida, United States, 32801
      • CNS Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Approximately 60 male and female participants 45 years of age or older who are overweight or obese will be enrolled. To ensure data are collected from a wide age range, 20 participants will be enrolled per specified age ranges. The study population must include at least 40% females in the overall study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age Range 45 to </= 60	Behavioral: Short Performance Physical Battery (SPPB Test); The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands.; Behavioral: 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.; Behavioral: Hand grip dynamometry; Grip strength is used as a marker of overall muscle strength.
Age Range 61 to </= 75	Behavioral: Short Performance Physical Battery (SPPB Test); The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands.; Behavioral: 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.; Behavioral: Hand grip dynamometry; Grip strength is used as a marker of overall muscle strength.
Age >/= 76	Behavioral: Short Performance Physical Battery (SPPB Test); The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands.; Behavioral: 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.; Behavioral: Hand grip dynamometry; Grip strength is used as a marker of overall muscle strength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants.	Baseline (+7 day window)
To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.	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 compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.	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)

Collaborators and Investigators

• Sponsor: Versanis Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): November 5, 2021
• Study Completion (Actual): November 5, 2021

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: VER201-OBS-032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No