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OpenTrials
Completed

NCT Number: NCT05174923

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

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

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Key information

Conditions

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

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CNS Healthcare, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short Performance Physical Battery (SPPB Test)

Behavioral

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

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.

Hand grip dynamometry

Behavioral

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

Primary outcomes

  1. To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants.

    Time frame: Baseline (+7 day window)

  2. To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline (+7 day window)

  5. To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.

    Time frame: 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).

    Time frame: Baseline (+7 day window)

Sponsors and collaborators

Lead sponsor

Versanis Bio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 3, 2022
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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