ObesityNCT05174923
Variability of Physical Assessments in an Older Population That is Overweight or Obese
An observational study of Obesity and Aging, run by Versanis Bio, Inc. at 2 sites in United States.
Trial summary
Variability of physical assessments in an older population that is overweight or obese. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- What is being tested?
- Short Performance Physical Battery (SPPB Test), 30 Second Chair Stand Test (30CST) and Hand grip dynamometry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2021to 5 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CNS Healthcare
Jacksonville, Florida, 32256
CNS Healthcare
Orlando, Florida, 32801
About this study
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
Variability of physical assessments in an older population that is overweight or obese.
Read the 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.
- Being tested
- Short Performance Physical Battery (SPPB Test), 30 Second Chair Stand Test (30CST), Hand grip dynamometry
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Performance Physical Battery (SPPB Test)Behavioural
The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands.
30 Second Chair Stand Test (30CST)Behavioural
The 30CST measures the number of times a person can rise from a seated to standing position within 30 seconds.
Hand grip dynamometryBehavioural
Grip strength is used as a marker of overall muscle strength.
| Study group | Role | What they receive |
|---|---|---|
| Age Range 45 to </= 60 | Not described Receives: Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry | |
| Age Range 61 to </= 75 | Not described Receives: Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry | |
| Age >/= 76 | Not described Receives: Behavioral: Short Performance Physical Battery (SPPB Test); Behavioral: 30 Second Chair Stand Test (30CST); Behavioral: Hand grip dynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants.
Measured: Baseline (+7 day window)
To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.
Measured: 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.
Measured: 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.
Measured: Baseline (+7 day window)
To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.
Measured: Baseline (+7 day window)
To assess the correlation between bioelectrical impedance analysis (BIA) and waist circumference (WC) as well as body mass index (BMI).
Measured: Baseline (+7 day window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start20 Sep 2021
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versanis Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174923
- Sponsor's protocol ID
- VER201-OBS-032
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05174923
- Acronym / sponsor ID
- VER201-OBS-032
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Versanis Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Performance Physical Battery (SPPB Test)The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands. | Behavioural | Age >/= 76, Age Range 45 to </= 60, Age Range 61 to </= 75 |
| 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. | Behavioural | Age >/= 76, Age Range 45 to </= 60, Age Range 61 to </= 75 |
| Hand grip dynamometryGrip strength is used as a marker of overall muscle strength. | Behavioural | Age >/= 76, Age Range 45 to </= 60, Age Range 61 to </= 75 |
Primary outcome
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)
To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.
Time frame: 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)
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)
To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Aging, run by Versanis Bio, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.