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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05174923

Enrollment

Registered

2022-01-03

Start date

2021-09-20

Completion date

2021-11-05

Last updated

2022-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Obesity

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.

Interventions

BEHAVIORALShort Performance Physical Battery (SPPB Test)

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

BEHAVIORAL30 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.

BEHAVIORALHand grip dynamometry

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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 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 assess the correlation between bioelectrical impedance analysis (BIA) and waist circumference (WC) as well as body mass index (BMI).	Baseline (+7 day window)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026