Primary Outcomes

Description: Single Test for Attention, Executive Function and Mental Flexibility

Measure: Delis-Kaplan Executive Function System (D-KEFS) Stroop Inhibition-Switching Task

Time: 6 months after enrollment

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Primary Outcomes

Description: To be administered at: Screening Evaluation & Endpoint 13 week exercise test sessions This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS-5 is currently in the process of being validated however its previous version demonstrated excellent sensitivity (.81) and specificity (.95).57

Measure: Change from Baseline: Clinician Administered PTSD Scale -5

Time: Baseline and endpoint (at 13 weeks)

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Description: The WHY-MPI has been demonstrated to be applicable across a variety of clinical pain conditions. Its brevity, validity/ reliability, self-report nature and ease of scoring make it ideal for both clinical and research purposes. The WHY-MPI is sensitive to change following rehabilitation. Please note only the interference subscale of the WHY-MPI will be administered in this study.

Measure: Change from Baseline: West Haven=Yale Multidimensional Pain Inventory- Interference Subscale (WHY-MPI)

Time: Baseline, Midpoint (at 6 weeks) and Endpoint (at 13 weeks)

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Primary Outcomes

Description: Weight will be obtained using the same scale over the study period that is accessible to people with and without a mobility device (e.g. walker; wheelchair)

Measure: Change in weight

Time: Baseline, 3 months, 6, months, 12 months, and 18 months

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Secondary Outcomes

Description: The Garmin Vivofit will be worn for the study duration to measure physical activity data.

Measure: Step Count

Time: 3 months, 6 months, 12 months, and 18 months

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Description: Waist circumference will be measured at the umbilicus and mild-upper arm circumference following American College of Sports Medicine guidelines.

Measure: Waist and Arm Circumference

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: Using an automatic cuff (average of three readings, patient seated) diastolic and systolic scores will be recorded.

Measure: Blood Pressure

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: Fasting venous sample will be obtained for blood glucose, HDL/LDL, cholesterol, and triglyceride level.

Measure: HbA1c and Lipid Panel

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: The Framingham Heart Study diabetes risk score will be calculated using predictors including age, gender, fasting glucose, body mass index, HDL cholesterol and triglyceride levels, blood pressure, and parental history. Risk score calculator and regression model are free and used in GLB weight-loss trials. Each risk predictor is assigned points ranging from. Risk factors are combined and a total score is calculated, with higher scores designating greater 8-year risk.. The age range for this score is 45 years or older, and therefore only individuals over this age will have calculated scores. Furthermore, the minimum cut-off score is 3.

Measure: Risk of Diabetes

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: Satisfaction with life will be measured using the Satisfaction with Life Scale (SWLS). The SWLS is a 5-item scale designed to measure global cognitive judgements of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7-strongly agree to 1-strongly disagree. Scores are added together and a total score is calculated, with higher scores signifying higher satisfaction with life and lower scores signifying lower satisfaction with life.

Measure: Satisfaction with Life

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: TSH, Cortisol, IL-6, THNF, BDNF, IGF, and VEGF will be collected.

Measure: Biomarkers

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: Assesses walking speed in (m/s) which is correlated to mobility in the community, capacity to perform ADLs, risk of falls, re-hospitalization, and risk of cognitive decline.

Measure: 10 Meter Walk Test (10MWT)

Time: Baseline, 3 months, 6 months, and 12 months

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Description: Assesses distance walked (rolled for wheelchair users) over 6 minutes as a sub-maximal test of aerobic capacity.

Measure: 6 Minute Walk Test (6MWT)

Time: Baseline, 3 months, 6 months, and 12 months

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Description: Social Support for Diet and Exercise Behaviors Scale is a 23-item survey including four subscales: support for healthy eating (5 items); support for physical activity (11 items); social undermining for healthy eating (5 items) and physical activity (2 items). Each item is rated on a scale of 1 to 5 (1 none; 5 very often), with respondents asked to rate support from family, friends, and coworkers. Higher scores represent greater support and internal consistency ranged from Cronbach's α 0.72-0.76.

Measure: Social Support assessed by the Social Support for Diet and Exercise Behaviors Scale

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: The Feasibility and Usability survey includes 14 items that assesses the participant's subjective experience with the App, level of difficulty, prompting sequence, length, and understanding. Scores above 3 on the scale (1 [totally disagree] - 5 [totally agree]) indicate that the App was easy to use.

Measure: App Feasibility and Usability using the Feasibility and Usability Survey

Time: 6 months, 12 months, and 18 months

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Description: NEWS assesses residents' perception of neighborhood design features, categorized into subscales related to physical activity, including residential density, land use mix (including both indices of proximity and accessibility), street connectivity, infrastructure for walking/cycling, neighborhood aesthetics, traffic and crime safety, and neighborhood satisfaction. Subscales are scored as a mean of items. Higher scores denote higher walkability.

Measure: Neighborhood Walkability assessed by the Neighborhood Environment Walkability Scale (NEWS)

Time: Baseline and 12 months

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Description: Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices score plus 4 subscales scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.

Measure: Self-Reported Activities of Health using the Self-Reported Activities of Health for Health Promotion Scale

Time: Baseline, 12 months, and 18 months

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Description: This inventory consists of 40 life events and asks the participant to recall if any of the events happened within the previous year (e.g., death of spouse; personal illness; change in sleep). Endorsement of these events are totaled and higher scores indicate a greater amount of stressful life events. Point values for the Holmes and Rahe Stress Inventory were weighted and summed for each individual based on scoring instructions. Individuals who scored 150 points or less were categorized as low susceptibility to a health breakdown in the next two years, 151-300 points were 50% chance of health breakdown, and 301 points or more were 80% chance of health breakdown.

Measure: Stressful Life Events assessed by the Holmes and Rahe Stress Inventory

Time: Baseline, 3 months, 6 months, 12 months, and 18 months

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Description: The GLB TBI/Attention Control groups will both use this app. Usage and engagement will be collected.

Measure: App Data

Time: 6 months, 12 months, and 18 months

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Description: The MOCA is a brief, 8-section assessment of various cognitive domains including executive function, memory, language, attention, concentration, orientation, and working memory in neurologic populations. Each item on the MOCA is allocated a set of points adding up to 30.

Measure: Executive Function assessed by the Montreal Cognitive Assessment

Time: Baseline, 3 months, and 12 months

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Description: Self-Report Habit Index measures self-reported perceptions of habit strength for an identified behavior. The measure has high internal reliability across four studies. The measure consists of 12 items using a 7-point Likert scale ranging from "completely disagree" to "completely agree", with higher scores representing greater perception of habit strength.

Measure: Self-reported perceptions of habit strength assessed by the Self-Report Habit Index (SRHI)

Time: Baseline, 3 months, and 12 months

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Description: The PHQ-8 is a brief self-report measure of major depressive disorder, derived from the PHQ-9 by removing the last question regarding suicide assessment.It is considered to be a valid measure of depression for population-based studies and clinical populations, and has been used in studies of patients with physical injury. Frequency of symptoms during the last 2 weeks is assessed on a 0 (not at all) to 3 (nearly every day) scale. A cut-off score of 10 or greater is considered diagnostic for current depression

Measure: Depression assessed using the Patient Health Questionnaire-8 item

Time: Baseline, 12 months, and 18 months

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Description: Walk Score is publically available and measures walkability of any address using a patented system. Fore each address, Walk Score analyzes hundreds of walking routes to nearby amenities and awards points based on distance to each amenities. Scores are given on a scale of 0 to 100.

Measure: Walk Score

Time: Baseline and 12 months

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Description: The BAST is a 47 item, theoretically grounded, validated survey of behavioral and emotional symptoms for community-based adults with TBI. This assessment is a shortened version of the validated 77-item survey, with questions related to environmental stressors and mood removed due to repetitiveness to other questions in survey packet. Responses are asked over the past two weeks using an ordinal scale from 0 "rarely" to 5 "very often." There are 6 subscales: Negative Affect, Substance Use, Executive Function, Fatigue, Impulsivity, and Maladaptive Coping. Higher scores indicate more symptoms in those domains. This measure will be used to characterize behavioral/emotional symptoms and to explore whether these are factors that influence

Measure: Behavioral Assessment

Time: Baseline and 6 months

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Description: The ten items from the General Self-Efficacy Scale (GSE) are deigned to examine goal-setting, effort investment, persistence in face of barriers and recovery from setbacks as constructs of perceived self-efficacy. The total score is the sum ranging from 10-40 and the instrument has been normed against the U.S. Adult population with a mean score of 29.48.

Measure: General Self Efficacy

Time: Baseline, 12 months, and 18 months

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Description: The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventative health practices, and health care access primarily related to chronic disease and injury. The GLB-TBI uses the two subscales of Healthy Eating and Physical Activity from the 2017 version of the BRFSS. It consists of 14 items.

Measure: Behavioral Risk Factor Surveillance

Time: Baseline, 3, 6, 12, and 18 months.

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Description: This is an FDA cleared and validated indirect calorimetry device. It is handheld and measures oxygen consumption (V02) to determine resting metabolic rate (RMR)

Measure: MedGem

Time: Baseline

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Description: The metabolic score calculator will be used at all time points to determine the risk for metabolic syndrome. The following variables will be used to determine metabolic risk using the free metabolic risk calculator: gender, race and ethnicity, systolic blood pressure, fasting glucose, triglycerides, high-density lipoprotein (HDL), weight, height, and waist circumference. Scores are calculated are standardized to the general population.

Measure: Metabolic Score Calculator (MetS)

Time: Baseline, 3, 6, 12, and 18 months

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Description: Information on substance use will be collected using the AUDIT-C (for alcohol use) and three questions regarding tobacco and non-prescriptive drug use.

Measure: Substance Use

Time: Baseline, 12 months

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Description: This self-report survey was developed by the National Institute of Mental Health. The full survey consists of 64 questions with an open-ended section at the end to elicit concerns and feedback related to the effects of COVID-19. For this current study, however, only sections on Exposure Status (10 items), Life Changes (15 items), and Emotions/Worries (7 items), and the open-ended question will be asked. Questions are asked "over the past two weeks."

Measure: CRISIS (CoRonavIruS Health Impact Survey) V0.3 Adult Baseline Form

Time: Up to 12 months

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Description: The Social Isolation Short-Form 4a is taken from the Patient-Reported Outcomes Measurement Information System (PROMIS). This form assesses the perceptions of being "avoided, excluded, detached, disconnected from, or unknown by, others. There is no timeframe for the form. The measure is normed to the US population.

Measure: PROMIS Social Isolation Short Form 4a

Time: Up to 12 months

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Description: To assess media exposure and fear of media exposure during COVID-19 we have added 6 questions. These are asked "over the past two weeks." These questions address time spent watching the television, listening to radio, reading the newspaper, and searching the internet and social media. In addition, a 6th question related to fear is asked using a 5-point Likert scale.

Measure: Media Questionnaire

Time: Up to 12 months

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Primary Outcomes

Description: NIH PROMIS Pain Scale 4 questions; each question is a 0-4 scale, total score range is 0-16 Higher scores represent worse outcomes

Measure: self-reported pain change determined via the NIH PROMIS scale

Time: Pre- and post-4 weeks of MBLT or sham treatment, and 12 weeks following the end of MBLT or sham treatment

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Primary Outcomes

Description: The cardiorespiratory fitness is measured using a heart rate recovery test

Measure: Change from baseline cardiorespiratory fitness at 3 months

Time: Baseline and post 12-week intervention

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Description: Muscle strength is measured with grip strength using a hand-held dynamometer.

Measure: Change from baseline muscle strength at 3 months

Time: Baseline and post 12-week intervention

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Secondary Outcomes

Description: Lower extremity function is assessed using the Short Physical Performance Battery (SPPB)

Measure: Change from baseline lower extremity function at 3 months

Time: Baseline and post 12-week intervention

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Description: Lower extremity function will be assessed using the Timed Up and Go (TUG) test.

Measure: Change from baseline lower extremity function at 3 months

Time: Baseline and post 12-week intervention

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Description: Health-related quality of life is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Items. The instrument is a 10-item measure with the response scores ranging from 1 (very severe) to 5 (none). Two summary scores, a global physical health score and a global mental health score, can be calculated from this scale, with each score ranging from 4 to 20. Higher scores indicate better health. The total raw score is translated into a T-score for each participant for analysis.

Measure: Change from baseline health-related quality of life at 3 months

Time: Baseline and post 12-week intervention

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Description: Social participation is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.

Measure: Change from baseline social participation at 3 months

Time: Baseline and post 12-week intervention

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Description: Physical activity is measured using the Godin Leisure Time Exercise Questionnaire. The questionnaire contains two questions. The first question asks participants to report weekly frequencies of activities they perform at different intensities. A total weekly leisure activity is a sum of activity scores calculated by multiplying the weekly frequencies of strenuous, moderate, and light activities by 9, 5, and 3, respectively. The second question asks participants the frequency of weekly leisure-time activities performed that are long enough to work up a sweat.

Measure: Change from baseline physical activity at 3 months

Time: Baseline and post 12-week intervention

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Other Outcomes

Description: Barriers in physical activity will be assessed using the Barriers in Physical Activity Questionnaire. The instrument contains 43 items. Each item is responded with either no (1) or yes (2). If response is yes, a follow-up response that ranges from 1 (very small) to 5 (very large) is selected. There are 8 domains, which include personal health, attitudes/beliefs towards physical activity, friends, family, fitness center built environment, policy/programs/staff, community built environment, and safety. Each domain score is calculated by summing the item responses with its respective item weight. Higher domain scores indicate greater perceived barriers to physical activity.

Measure: Change from baseline barriers in physical activity at 3 months

Time: Baseline and post 12-week intervention

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Description: Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale. The scale contains 8 items, with response options of each item ranging from 0% (not at all confident) to 100% (highly confident). All items are summed and a mean score is calculated. Higher scores indicate higher levels of self-efficacy.

Measure: Change from baseline exercise self-efficacy at 3 months

Time: Baseline and post 12-week intervention

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Description: Exercise goal-setting will be measured using the Exercise Goal-Setting Scale. The instrument contains 10 items with response options ranging from 1 (does not describe) to 5 (describes completely). A mean score is calculated. A higher mean score indicate better goal-setting and self-monitoring for exercise.

Measure: Change from baseline exercise goal-setting at 3 months

Time: Baseline and post 12-week intervention

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Description: Outcome expectations for exercise will be assessed using the Multidimensional Outcome Expectations for Exercise Scale. The instrument contains 15 items, with the response options ranging from 1 (strongly disagree) to 5 (strongly agree). Three domains of outcome expectations for exercise are assessed, which include physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items). Each dimension is scored by summing the item responses. Higher scores indicate higher levels of outcome expectations for exercise.

Measure: Change from baseline outcome expectations for exercise at 3 months

Time: Baseline and post 12-week intervention

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Description: Social support will be assessed using the Social Provision Scale. The instrument contains 24 items, with the response options ranging from 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing scores from all items. A higher score indicates a greater degree of perceived support.

Measure: Change from baseline social support at 3 months

Time: Baseline and post 12-week intervention

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Primary Outcomes

Description: the gold standard for PTSD diagnosis, a trained expert administrator scores PTSD symptom severity; range 0-80, higher score represents greater severity

Measure: Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)

Time: week 10

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Secondary Outcomes

Description: well-validated and widely used 9-item self-report measure of depression symptom severity, range 0-27, higher score represents greater severity

Measure: Change in Patient Health Questionnaire (PHQ-9) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

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Description: a reliable 20-item screen for PTSD, in which each item is rated on a 5-point Likert scale, range 0-80, higher score represents greater severity

Measure: Change in PTSD Checklist for DSM5 (PCL5) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

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Description: a clinically validated 9-item assessment of sleep quality and sleep disturbances; range 0 to 21, higher score represents greater severity

Measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

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Description: a reliable 22-item self-report measure assessing functional status and post concussive symptoms, range 0-88, higher score represents greater severity

Measure: Change in Neurobehavioral Symptom Inventory (NSI) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

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Description: a reliable 100 item self-report inventory measuring overall quality of life in 8 dimensions; range 100 to 500, higher score represents greater severity

Measure: Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score

Time: week 10, and 2, 6 and 12 months later, compared to baseline

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Other Outcomes

Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the single molecule array (SIMOA) technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma tumor necrosis factor-alpha level

Time: week 10, compared to baseline

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Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-6 level

Time: week 10, compared to baseline

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Description: inflammatory cytokine that increases with physical and psychological trauma, measured at the picogram per milliliter level, present in plasma at detectable levels in all individuals with the SIMOA technology to be applied, but expected to decrease in response to intervention

Measure: Change in plasma interleukin-10 level

Time: week 10, compared to baseline

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Description: Normalized Summary Score for a battery of 7 tests to measure various aspects of cognition including memory, executive function, attention span; normed for age, with a score of 50 being average, scores greater than 50 demonstrate greater than average cognitive function, and scores lower than 50 indicating lower than average cognitive function

Measure: Change in NIH Toolbox Cognition Battery (NIH-TB) Neurocognitive Assessment Composite Score

Time: week 10, compared to baseline

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Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

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Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

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Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

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Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

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Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

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Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years

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Primary Outcomes

Measure: World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item

Time: Initial assessment, past 30 days.

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Secondary Outcomes

Measure: Rivermead Postconcussion Symptom Questionnaire

Time: initial assessment, past 24 hours.

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Primary Outcomes

Measure: In-hospital Mortality

Time: At hospital discharge, approximately 1 month

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Measure: 30-day mortality

Time: 30 days post-hospital discharge

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Secondary Outcomes

Description: Care treatment such as ventilator use, intubation, and/or tracheostomy

Measure: Limitations of patient care- Frequency of care not being provided

Time: During In-hospital course, up to 1 month

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Measure: Limitations of patient care- Conversion of DNR/DNI/CMO status

Time: During In-hospital course, up to 1 month

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