Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Grip Strength |
Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change. |
Change between baseline and follow-up at 26-weeks |
|
| Primary |
Change in 30 Second Sit-to-Stand (STS) |
STS measures lower limb strength - change represented as repetitions. |
Change between baseline and follow-up at 26-weeks |
|
| Primary |
Change in Six-Minute Walk Test (6MWT) |
A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m |
Change between baseline and follow-up at 26-weeks |
|
| Primary |
Change in Gait Speed (Meters Per Second) |
Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (a significant change is considered 0.1 meters per second). |
Change between baseline and follow-up at 26-weeks |
|
| Primary |
Change in Late-Life Function and Disability Instrument (LLFDI) |
LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. For this instrument we use only the 32-item function and scores are scaled. Minimum 0, Maximum 100. Higher scores indicate higher levels of function |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Behavioral Activation (Patient Activation Measure) |
Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors & outcomes. Score ranges from 0 to 100, higher scores indicate higher activation. |
baseline and follow-up at 26-weeks |
|
| Secondary |
Subjective Health Status (PROMIS) |
Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. A score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better health. |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Change in Weight in kg |
Change in weight in kg |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Change in Body Mass Index (BMI) in kg/m^2 |
Change in body mass index (BMI) in kg/m^2 |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Change in Waist Circumference in cm |
Change in waist circumference in cm |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Steps |
Fitibit will assess steps |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - |
CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Frequency Per Week |
CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. |
Change between baseline and follow-up at 26-weeks |
|
| Secondary |
Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Hours Per Week |
CHAMPS is a self-reported tool in older adults that assesses activity levels and types. A change in score represents a change in the rates of participants in that specific category. A lower number (mean) represents a decrease in the proportion of individuals, while a positive change indicates an increase in the rate of persons. For caloric input, this continuous measure aligns with changes in calories based on activity type per week. |
Change between baseline and follow-up at 26-weeks |
|
