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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44AG076087-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
It is well established that in-person resistance training is an effective form of exercise to increase physical function and quality of life amongst adults. However, older adults report not participating in resistance training due to lack of age appropriate programs, fear of a gym setting, poor access to a gym, joint and other kinds of pain, and lack of social support. These barriers have been compounded as a result of COVID-19 pandemic, wherein older adults are encouraged to socially isolate, leading to even less physical activity. Vivo is a virtual small group exercise program designed for adults 55 and addresses these major barriers to strength training by coaching through an interactive online training session incorporating social support and social engagement.
The investigators plan is to test a highly attractive technology platform specifically designed to meet the needs of older adults to demonstrate that resistance training exercise can be scaled and effective with diverse older adults and remove the barrier of having to go to a gym setting to see benefits. The investigators will test feasibility in a real world sample of adults ≥60 with prediabetes, a very prevalent, serious and often silent health condition that affects 1 in 3 adults in the US and is associated with high rates of sarcopenia, or loss of muscle mass.
In the next study, Phase II NCT06458530, investigators will examine the effects of Vivo on physical function and glycemic level in sedentary older with prediabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivo strength training | Other | Participants will exercise virtually, 2 days a week for 12 weeks for a 45 minute live, interactive strength training workout. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivo workout | Behavioral | 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leg Strength Assessed Through a 30 Second Chair Rise Test | Participants completed as many chair stands as they could in 30 seconds | at 3 months (endpoint) |
| Workout Attendance | Attendance to each workout session was tallied. A possible 24 workout sessions were offered for the intervention (12 weeks of 2 days a week for workouts). The number of participants includes everyone who completed intervention, excluding those who stopped intervention at some point. The data reported represents the overall percent attendance of the participants that completed the intervention (N=22 participants). Attendance was calculated by averaging the number of sessions attended divided by the total number of exercise sessions attended (24 sessions). | after each workout session for up to 3 months (endpoint) |
| Intervention Engagement Assessed by Self- Reported Ease of Use | Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree | at 3 months (endpoint) |
| Program Satisfaction | Participants completed the question on a questionnaire to answer "What was your overall satisfaction with Vivo?" Responses are percentage of participant who reported being satisfied or very satisfied with the Vivo intervention. A higher number indicates higher satisfaction. | at the 3 month (endpoint) |
| Exercise Intervention Trainer Fidelity Checklist | The exercise intervention fidelity as assessed at 4 time points over the course of the 12-week exercise program using a 9-item checklist to ensure unbiased assessment. The purpose was to observe the exercise session to see if the main areas of the intervention were being delivered; workout intensity, safety, and participation and engagement. The results below indicate the percentage of exercise workouts that met the 9-item checklist. A higher score indicates higher fidelity. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and at 3 months (endpoint) |
| Satisfaction With Life Measured by the 5 Item SWL Questionnaire |
Inclusion Criteria:
Age ≥ 60 years;
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
Unable to provide consent
Weight instability
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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Participants were recruited from electronic medical records in Duke Maestro Care as described in the Clinical Trials Information. All participants who enrolled and were eligible for the trial participated in the feasibility study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivo Intervention | Participants participated via Zoom in a virtual exercise class 2 days/week for 45 minutes for 12 weeks. Exercise classes were led by a certified trainer and each class focused on building strength, flexibility, balance, and cognitive skills |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vivo Strength Training | Vivo workout: 2 days a week for 12 weeks of a live, interactive virtual strength training program. Each class is 45 minutes long and lead by a certified trainer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Leg Strength Assessed Through a 30 Second Chair Rise Test | Participants completed as many chair stands as they could in 30 seconds | Posted | Mean | Standard Deviation | number of chair stands | at 3 months (endpoint) |
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Adverse event data was collected for each participant from enrollment to study completion or study withdraw. The duration of participation in the study was approximately 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vivo Intervention | Participants participated via Zoom in a virtual exercise class 2 days/week for 45 minutes for 12 weeks. Exercise classes were led by a certified trainer and each class focused on building strength, flexibility, balance, and cognitive skills |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Levitan | IMPACTIV (Vivo) | 770-331-3208 | eric@teamvivo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2022 | Sep 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009133 | Muscular Atrophy |
| D018908 | Muscle Weakness |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| over the course of the 12 week intervention |
Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL) |
| 3 months |
| Profile of Mood Survey (POMS) | Changes from baseline to 3 months will assess participant's changes in mood. | baseline and at 3 months (endpoint) |
| 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 | baseline and at 3 months (endpoint) |
| Exercise Efficacy | Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors | baseline and at 3 months (endpoint) |
| 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) | baseline and at 3 months (endpoint) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Leg strength assessed through a 30 second chair rise test | Mean | Standard Deviation | chair stands |
|
|
|
| Primary | Workout Attendance | Attendance to each workout session was tallied. A possible 24 workout sessions were offered for the intervention (12 weeks of 2 days a week for workouts). The number of participants includes everyone who completed intervention, excluding those who stopped intervention at some point. The data reported represents the overall percent attendance of the participants that completed the intervention (N=22 participants). Attendance was calculated by averaging the number of sessions attended divided by the total number of exercise sessions attended (24 sessions). | 22 participants completed the intervention. Each participant had the opportunity to attend 24 exercise sessions. The attendance rate was calculated based on the number of sessions the participant attended divided by the total possible sessions (24 sessions). The attendance rate was then averaged across the participants who completed the intervention. | Posted | Mean | Full Range | percent of attendance | after each workout session for up to 3 months (endpoint) | exercise sessions | exercise sessions |
|
|
|
| Primary | Intervention Engagement Assessed by Self- Reported Ease of Use | Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree | Posted | Number | percent of participants | at 3 months (endpoint) |
|
|
|
| Primary | Program Satisfaction | Participants completed the question on a questionnaire to answer "What was your overall satisfaction with Vivo?" Responses are percentage of participant who reported being satisfied or very satisfied with the Vivo intervention. A higher number indicates higher satisfaction. | Posted | Number | percent of participants | at the 3 month (endpoint) |
|
|
|
| Primary | Exercise Intervention Trainer Fidelity Checklist | The exercise intervention fidelity as assessed at 4 time points over the course of the 12-week exercise program using a 9-item checklist to ensure unbiased assessment. The purpose was to observe the exercise session to see if the main areas of the intervention were being delivered; workout intensity, safety, and participation and engagement. The results below indicate the percentage of exercise workouts that met the 9-item checklist. A higher score indicates higher fidelity. | There were 4 exercise cohorts in this feasibility study, taught by different trainers. To ensure exercise fidelity across the cohorts, 4 exercise sessions from each cohort were observed for a total of 16 observed exercise sessions. A 9-item checklist was used to ensure components of the sessions were being met. The 16 sessions met 96% of the checklist components. | Posted | Number | percentage of workouts meeting checklist | over the course of the 12 week intervention | exercise sessions | exercise sessions |
|
|
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| Other Pre-specified | 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) | Not Posted | Dec 2025 | baseline and at 3 months (endpoint) | Participants |
| Other Pre-specified | 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) | Not Posted | Dec 2025 | 3 months | Participants |
| Other Pre-specified | Profile of Mood Survey (POMS) | Changes from baseline to 3 months will assess participant's changes in mood. | Not Posted | Dec 2025 | baseline and at 3 months (endpoint) | Participants |
| Other Pre-specified | 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 | Not Posted | Dec 2025 | baseline and at 3 months (endpoint) | Participants |
| Other Pre-specified | Exercise Efficacy | Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors | Not Posted | Dec 2025 | baseline and at 3 months (endpoint) | Participants |
| Other Pre-specified | 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) | Not Posted | Dec 2025 | baseline and at 3 months (endpoint) | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 3 |
| 22 |
| Back pain following a skiing accident | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shoulder pain following exercise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| D004700 | Endocrine System Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D006943 | Hyperglycemia |
| Title | Measurements |
|---|---|
|