Muscle Loss, Muscle Weakness, Older Adults, PreDiabetes
Conditions
Keywords
older adults, pre diabetes, strength training, muscle weakness, resistance training, virtual, intervention
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALVivo 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.
Sponsors
Duke University
National Institute on Aging (NIA)
Eric Levian
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg Strength Assessed Through a 30 Second Chair Rise Test | at 3 months (endpoint) | Participants completed as many chair stands as they could in 30 seconds |
| Workout Attendance | after each workout session for up to 3 months (endpoint) | 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). |
| Intervention Engagement Assessed by Self- Reported Ease of Use | at 3 months (endpoint) | Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree |
| Program Satisfaction | at the 3 month (endpoint) | 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. |
| Exercise Intervention Trainer Fidelity Checklist | over the course of the 12 week intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life Measured Via the Short Form (SF)-36 | baseline and at 3 months (endpoint) | Change from baseline to 3 months will be assessed (scores range from 0-100 with higher scores indicating better health-related quality of life) |
| Satisfaction With Life Measured by the 5 Item SWL Questionnaire | 3 months | Changes from baseline to 3 months (SWL scores range from 5-35 with higher score indicating greater SWL) |
| Profile of Mood Survey (POMS) | baseline and at 3 months (endpoint) | Changes from baseline to 3 months will assess participant's changes in mood. |
| Perceived Stress Scale Center for Epidemiologic Studies Depression Scale (CES-D) | baseline and at 3 months (endpoint) | Changes from baseline to 3 months will assess participant's changes in perceived stress. likert scale from 0-4, higher scores indicate higher stress |
| Exercise Efficacy | baseline and at 3 months (endpoint) | Changes from baseline to 3 months will be assessed using a questionnaire measuring the participant's confidence in completing exercise related behaviors |
| Sleep Measured Via the Pittsburgh Sleep Quality Index (PSQI) | baseline and at 3 months (endpoint) | Change from baseline to 3 months (PSQI scores range from 0-21 with higher scores indicating worse sleep quality) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Vivo Strength Training |
|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Leg strength assessed through a 30 second chair rise test | 12.1 chair stands STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 3 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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.
Time frame: over the course of the 12 week intervention
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivo Strength Training | Exercise Intervention Trainer Fidelity Checklist | 96 percentage of workouts meeting checklist |
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
Time frame: at 3 months (endpoint)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vivo Strength Training | Intervention Engagement Assessed by Self- Reported Ease of Use | Easy to follow workout instructions during class | 86 percent of participants |
| Vivo Strength Training | Intervention Engagement Assessed by Self- Reported Ease of Use | Level system made it easy to tailor intensity and exercises to my abilities | 95 percent of participants |
| Vivo Strength Training | Intervention Engagement Assessed by Self- Reported Ease of Use | Easy to sign into class | 82 percent of participants |
Primary
Leg Strength Assessed Through a 30 Second Chair Rise Test
Participants completed as many chair stands as they could in 30 seconds
Time frame: at 3 months (endpoint)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vivo Strength Training | Leg Strength Assessed Through a 30 Second Chair Rise Test | 14.2 number of chair stands | Standard Deviation 2.9 |
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.
Time frame: at the 3 month (endpoint)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vivo Strength Training | Program Satisfaction | 95 percent of participants |
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).
Time frame: after each workout session for up to 3 months (endpoint)
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vivo Strength Training | Workout Attendance | 85 percent of attendance |
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
Time frame: baseline and at 3 months (endpoint)
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)
Time frame: baseline and at 3 months (endpoint)
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
Time frame: baseline and at 3 months (endpoint)
Other Pre-specified
Profile of Mood Survey (POMS)
Changes from baseline to 3 months will assess participant's changes in mood.
Time frame: baseline and at 3 months (endpoint)
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)
Time frame: 3 months
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)
Time frame: baseline and at 3 months (endpoint)