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

December 13, 2021 updated by: Versanis Bio, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • CNS Healthcare
      • Orlando, Florida, United States, 32801
        • CNS Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Baseline (+7 day window)
To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.
Time Frame: Baseline (+7 day window)
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.
Time Frame: Baseline (+7 day window)
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.
Time Frame: Baseline (+7 day window)
Baseline (+7 day window)
To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.
Time Frame: Baseline (+7 day window)
Baseline (+7 day window)
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)
Baseline (+7 day window)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Versanis Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VER201-OBS-032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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