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Variability of physical assessments in an older population that is overweight or obese.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age Range 45 to </= 60 |
| ||
| Age Range 61 to </= 75 |
| ||
| Age >/= 76 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Performance Physical Battery (SPPB Test) | Behavioral | The SPPB includes balance stands, a 4-meter walk and 5 timed chair stands. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNS Healthcare | Jacksonville | Florida | 32256 | United States | ||
| CNS Healthcare |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 31, 2022 | |
| Reset | Oct 24, 2023 | |
| Release | Feb 23, 2024 | |
| Reset | Aug 30, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 31, 2022 | Oct 24, 2023 | |||
| Feb 23, 2024 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| Orlando |
| Florida |
| 32801 |
| United States |
| Aug 30, 2024 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |