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

NCT05174923 | Completed

• 1 other identifier: VER201-OBS-032
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity; Aging

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (3)

Age Range 45 to </= 60

Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry

Age Range 61 to </= 75

Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry

Age >/= 76

Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry

Interventions

Short Performance Physical Battery (SPPB Test) BEHAVIORAL

The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands.

Age >/= 76; Age Range 45 to </= 60; Age Range 61 to </= 75

30 Second Chair Stand Test (30CST) BEHAVIORAL

The 30CST measures the number of times a person can rise from a seated to standing position within 30 seconds.

Age >/= 76; Age Range 45 to </= 60; Age Range 61 to </= 75

Hand grip dynamometry BEHAVIORAL

Grip strength is used as a marker of overall muscle strength.

Age >/= 76; Age Range 45 to </= 60; Age Range 61 to </= 75

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Versanis Bio, Inc.: lead

Study Sites (2)

CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

CNS Healthcare

Orlando, Florida, 32801, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: January 3, 2022
• Study Start: September 20, 2021
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)