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. A higher score represents a better outcome. |
Baseline and 17 weeks |
|
| Primary |
Change in 5 times Sit-to-Stand (STS) |
STS measures lower limb strength (minimal change 2.3 s). A higher score represents a better outcome. |
Baseline and 17 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 |
Baseline and 17 weeks |
|
| Primary |
Change in weight in kg |
Change in weight in kg |
Baseline and 17 weeks |
|
| Primary |
Change in body mass index (BMI) in kg/m^2 |
Change in body mass index (BMI) in kg/m^2 |
Baseline and 17 weeks |
|
| Primary |
Change in subject processing speed |
Single Digit Modalities Test: Measure of cognition/processing speed. Score range 0 to 110. A higher score represents a better outcome. |
Baseline and 17 weeks |
|
| Primary |
Change in language function |
Boston Naming Test (BNT) is used to evaluate language function. Score range:0-42; higher score indicates better performance. |
Baseline and 17 weeks |
|
| Primary |
Change in subject cognition |
Verbal fluency test is used to evaluate language function. Performance will be identified via the total number of appropriate words responded on each of the task. Higher score indicates better performance. |
Baseline and 17 weeks |
|
| Primary |
Change in subject executive function |
Stroop test is used to assess executive function. Higher score indicates better performance. Raw score range: 0-300. |
Baseline and 17 weeks |
|
| Primary |
Change in speed processing |
Trail making Test-A&B is used to assess information processing speed. Shorter time indicates better performance. |
Baseline and 17 weeks |
|
| Primary |
Change in subject memory |
California Verbal Learning Test II (CVLT-II) Trials 1-5 Total raw score (range: 0-80; higher values represent a better outcome) |
Baseline and 17 weeks |
|
| Primary |
Change in Brief Visuospatial Memory Test-Revised (BVMT-R) |
BVMT-R is used to evaluate spatial memory ability. Scores range from 0 to 60, with higher values indicating better performance. |
Baseline and 17 weeks |
|
| Primary |
Change from baseline Anxiety Symptoms at 17 weeks |
will be assessed using the Generalized Anxiety Disorder-7 (GAD7). The GAD7 scores range from 5-21, with 5-9 indicating mild, 10-14 moderate, and greater than 15 severe anxiety. |
Baseline and 17 weeks |
|
| Primary |
Change from baseline Mood Symptoms at 17 weeks |
Will be assessed using the Patient Healthy Questionnaire (PHQ9). The PHQ9 scores range from 0-27, with lower numbers indicating minimal to no depression and higher numbers indicating severe depression. |
Baseline and 17 weeks |
|
| Primary |
Change from baseline Subjective Health Status (PROMIS) at 17 weeks |
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. Higher score indicated more positive perceptions of overall health. |
Baseline and 17 weeks |
|
| Primary |
Change in Behavior Rating Inventory of Executive Function (BRIEF-A) |
Behavior Rating Inventory of Executive Function (BREIF-A) is used to evaluate executive functioning.This questionnaire consist of 75 items on which the patient's symptoms are rated on a 3-point Likert scale. The questionnaire provides a Global Executive Composite score (range 75-225) and two index scores: the Behavioral Regulation Index (range 30-90) and the Metacognitive Index (range 40-120) in addition to nine subscales: Inhibit (range 8-24), Shift (range 6-18), Emotional control (range 10-30), Self-monitor (range 6-18), Initiate (range 8-24), Working memory (range 8-24), Plan/organize (range 10-30), Task monitor (range 6-18) and Organization of materials (range 8-24). Higher scores indicate more executive difficulties. |
Baseline and 17 weeks |
|
| Primary |
Change in Prospective and Retrospective Memory Questionnaire (PRMQ) |
PRMQ is a questionnaire about daily memory difficulties. Higher scores represent worse outcomes. Total score ranges from 0-64. |
Baseline and 17 weeks |
|
| Secondary |
Baseline estimated level of intellectual ability |
Test of Premorbid Functioning which results in a total raw score ranging from 0-70, and is normatively scored based on respondents' age resulting in standard scores (mean = 100). Higher values indicate a higher premorbid level of intellect. |
Baseline |
|
| Secondary |
Handedness as measured by Edinburgh Handedness Inventory at Baseline |
A self report questionnaire assessing the dominance of one's right or left hand in everyday activities. |
Baseline |
|
