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Behavioral Intervention

Vivo for Prediabetes

N/A

Recruiting

Research Sponsored by Impactiv, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 60 years

Low functioning: 1) able to do at least 1 chair stand and 2) number of chair stands done in 30 seconds is below criterion-referenced fitness standards for maintaining physical independence for age and gender

Must not have

Inability to complete physical function assessment

Lower extremity amputation or paralysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial will last for 12 weeks and will look at how Vivo affects lower body strength and blood sugar levels compared to doing nothing."

Who is the study for?

This trial is for older adults who are not very active and have prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. They should be experiencing muscle weakness or loss due to aging.

What is being tested?

The study tests Vivo's effects on physical function, specifically leg strength measured by the number of chair stands in half a minute, and its impact on blood sugar control as indicated by HbA1c levels over a period of 12 weeks compared to those who wait for treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I can do at least one chair stand but less than the age/gender standard in 30 seconds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot complete physical function tests.

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I have had an amputation or paralysis in my lower body.

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I am using testosterone supplements.

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I do not have unstable heart conditions or uncontrolled high blood pressure.

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I have an active cancer that is not a non-melanoma skin cancer.

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I am unable to give my consent.

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I am on hemodialysis for end-stage kidney disease.

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I have a brain condition that affects my thinking or physical abilities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lower body strength

Secondary study objectives

Aerobic Endurance

Balance

Hemoglobin A1C (HbA1C)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vivo interventionExperimental Treatment1 Intervention

Participants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes.

Group II: Waitlist controlActive Control1 Intervention

Participants randomized to this arm will be asked to maintain their baseline physical activity for 12-weeks. They will be scheduled for the baseline and 12-week assessment and following the 12-week assessment, they will be offered enrollment into Vivo.

0 / 10Eligibility criteria met