PreDiabetes Clinical Trial
Official title:
Evaluating the Feasibility and Acceptability of Vivo, an Online, Live and Interactive Strength Training Program, in Sedentary Older Adults With Prediabetes.
Verified date | July 2023 |
Source | Impactiv, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research trial studies the effect of an online, live and interactive strength training program on physical function and strength in older adults with prediabetes.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 15, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Age = 60 years; - Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4% - Ambulatory and community-dwelling - Sedentary: less than 150 minutes of moderate physical activity OR less than 75 minutes of vigorous physical activity per week - Have not engaged in resistance training for at least 6 months prior to enrollment - Low functioning (defined as able to do at least 1 chair stand without using hand in 30 second but unable to meet the moderate function criteria for age and gender) - Access to WiFi (or internet connection) in defined exercise space - Willing to maintain weight and current diet throughout the study Exclusion Criteria: - Inability to complete physical function assessment or inability to do a chair stand without using hands. - Use of antidiabetic medications - Use of testosterone supplement or replacement - Clinical disorder precluding/interfering with participation or assessments - Unstable angina, arrhythmia, uncontrolled hypertension - End Stage Renal Disease on Hemodialysis - Lower extremity amputation or paralysis - Neurological conditions causing functional or pronounced cognitive impairments - Active malignancy except for non-melanomatous skin cancers - Unable to provide consent - Weight instability |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Eric Levian | Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention engagement assess by workout attendance older adults with prediabetes | workout attendance will be measured, reasons for missed workouts will be collected participation; b) ease of use; and c) overall satisfaction. Milestone 2: Assess trainer fidelity | 3 months | |
Primary | Intervention engagement assessed by self- reported barriers and facilitators | Participants will complete questions to answer their comfort level with using the technology platform functional specifications of the client-centered approach (results, goals, adherence, upcoming workouts), and social engagement and support. Milestone 2: Develop a clickable prototype of the platform. | 3 months | |
Primary | Program satisfaction | Participants will complete a questionnaire to answer "how satisfied are you with the program" | 3 months | |
Secondary | Leg strength assessed through a 30 second chair rise test | Participants will complete as many chair stands as they can in 30 seconds | 3 months | |
Secondary | Health-related quality of life measured via the Short Form (SF)-36 | Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life) | 3 months | |
Secondary | Sleep measured via the Pittsburgh Sleep Quality Index (PSQI) | Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality) | 3 months | |
Secondary | Satisfaction with Life measured by the 5 item SWL questionnaire | Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL) | 3 months | |
Secondary | Exercise Efficacy | Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors | 3 months | |
Secondary | Profile of Mood Survey (POMS) | Changes from baseline to 3 months will assess participant's changes in mood. | 3 months | |
Secondary | Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D) | Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress | 3 months |
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