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

• Sponsor: Versanis Bio, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05174923
• Collaborator: (none)
• Enrollment: 58
• Locations: 2
• Actual Duration (Months): 1.5
• Patients Per Site: 29
• Patients Per Site Per Month: 19.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Aging	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 Design

• Study Type: Observational
• Actual Enrollment: 58 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Sep 20, 2021
• Actual Primary Completion Date: Nov 5, 2021
• Actual Study Completion Date: Nov 5, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants. [Baseline (+7 day window)]

2. To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants. [Baseline (+7 day window)]

3. 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)]

4. 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)]

5. To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST. [Baseline (+7 day window)]

6. To assess the correlation between bioelectrical impedance analysis (BIA) and waist circumference (WC) as well as body mass index (BMI). [Baseline (+7 day window)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CNS Healthcare	Jacksonville	Florida	United States	32256
2	CNS Healthcare	Orlando	Florida	United States	32801

Sponsors and Collaborators

• Versanis Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Versanis Bio, Inc.
• ClinicalTrials.gov Identifier: NCT05174923
• Other Study ID Numbers: VER201-OBS-032
• First Posted: Jan 3, 2022
• Last Update Posted: Jan 3, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Jan 3, 2022