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Search / Trial NCT06458530

Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.

Launched by IMPACTIV, INC. · Jun 10, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Virtual Exercise Intervention Strength Training Older Adult Prediabetes Muscle Strength Small Group Training

ClinConnect Summary

This clinical trial is studying the effects of a program called Vivo on physical strength and blood sugar levels in older adults who are sedentary and have prediabetes. The trial will last for 12 weeks and will compare the results of those participating in the Vivo program with a group that will not receive the program right away. Researchers will look at how many chair stands participants can do in 30 seconds to measure strength and will also check average blood sugar levels through a test called HbA1c.

To be eligible for this trial, participants must be at least 60 years old, live in the community, and have been diagnosed with prediabetes in the past year. They should also be able to do at least one chair stand but struggle to meet fitness standards for their age and gender, and they should not have engaged in resistance training for the last six months. Participants will need access to WiFi for the exercise sessions. If you or someone you know fits this description and is interested, this trial could be a great opportunity to improve strength and manage blood sugar levels while contributing to important research.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 60 years
  • Ambulatory and community-dwelling
  • Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%
  • 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
  • Sedentary: less than 150 minutes of moderate physical activity OR less than 60 minutes of vigorous physical activity per week
  • Have not engaged in resistance training for at least 6 months prior to enrollment
  • Access to WiFi in defined exercise space
  • Exclusion Criteria:
  • Inability to complete physical function assessment
  • Use of antidiabetic medications
  • Use of testosterone supplement or replacement
  • Clinical disorder precluding/interfering with participation of assessments
  • Unstable angina, arrhythmia, uncontrolled hypertension
  • End Stage Renal Disease on Hemodialysis
  • Lower extremity amputation or paralysis
  • Neurological condition causing functional or pronounced cognitive impairments
  • Active malignancy except for non-melanomatous skin cancers
  • Weight instability (defined as gain or loss of ≥10% over the last 6 months)
  • Unable to provide consent

About Impactiv, Inc.

Impactiv, Inc. is a forward-thinking clinical trial sponsor dedicated to advancing innovative therapies through rigorous research and development. With a strong commitment to improving patient outcomes, Impactiv leverages cutting-edge technology and data-driven methodologies to streamline trial processes and enhance the efficiency of clinical studies. Our team of experienced professionals collaborates closely with investigators, regulatory agencies, and stakeholders to ensure the highest standards of safety and efficacy. By fostering collaboration and prioritizing patient-centric approaches, Impactiv is poised to make significant contributions to the healthcare landscape, ultimately bringing transformative solutions to market.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported