Clinical trial NCT05174923: Variability of Physical Assessments in an Older Population That is Overweight or Obese
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Aging
Lead sponsor: Versanis Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-03
Enrollment: 58
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants.
timeFrame: Baseline (+7 day window)
measure: To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.
timeFrame: Baseline (+7 day window)
measure: To assess the variability of grip strength results (kg) with the use of a hand grip dynamometer within and between participants.
timeFrame: Baseline (+7 day window)
measure: 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.
timeFrame: Baseline (+7 day window)
measure: To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.
timeFrame: Baseline (+7 day window)
measure: To assess the correlation between bioelectrical impedance analysis (BIA) and waist circumference (WC) as well as body mass index (BMI).
timeFrame: Baseline (+7 day window)
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
Study officials:
References: