ACTIVE_NOT_RECRUITING

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

Conditions

PreDiabetes Older Adult Muscle Loss Muscle Weakness Virtual Exercise Intervention Strength training Muscle strength Small group training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

Official Title

Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes

Quick Facts

Study Start:2024-07-09

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06458530

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.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Impactiv, 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 Registration Dates

Study Start Date2024-07-09

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-07-09

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Virtual Exercise Intervention
Strength training
Older Adult
Prediabetes
Muscle strength
Small group training

Additional Relevant MeSH Terms

PreDiabetes
Older Adult
Muscle Loss
Muscle Weakness