The purpose of this study is to create a research repository, composed of data collected during a digital physical activity program delivered by Sword Move to individuals undergoing those programs. Sword Move intends to increase physical activity levels to stimulate the adoption of healthier, more active lifestyles. This will allow investigators to observe the effects of participants' engagement in physical activity on a variety of health and wellness based outcomes.
Purpose This patient registry was designed as a research repository, composed of data collected during a digital physical activity program delivered by Sword Move to individuals undergoing those programs. This data will allow the researchers to: 1. Assess the adoption, engagement and feasibility of digital physical activity programs to increase physical activity and its subsequent effect on health and wellness; 2. Assess the results of digital physical activity programs and compare the costs with the benefits obtained; 3. Correlate the results with patient's demographic and health condition profiles; Increase the knowledge regarding physical activity and its resultant effect on mental and physical health metrics; 4. Develop new or improved tools designed to help people improve physical activity levels and adopt healthier lifestyles. Design Prospective, observational study Study population These programs will cover all participants interested in improving their health and wellness through increased physical activity. Participants will be going through a personalized physical activity program tailored to each participant, with variations in frequency, duration, and type of activity based on their preferences, goals, fitness level, and physical ability. Outcomes The primary outcome will be the participant's progress along the program. Depending on the condition, primary and secondary outcome measures vary, but the registry will include, in all cases, a complete characterization of the participant's physical health status, as well as the periodic assessment of: a) performance indicators (through condition-specific tests); b) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); c) compliance; d) patient satisfaction.
Study Type
OBSERVATIONAL
Enrollment
300,000
Personalized physical activity program tailored to each participant, with variations in frequency, duration, and type of activity based on their preferences, goals, fitness level, and physical ability.
Sword Health
New York, New York, United States
Member Progress (PGIC)
Measured through the Patient Global Impression of Change (PGIC) questionnaire. Scores reflect the participant's perceived overall improvement (range 1-7), with higher scores indicating greater improvement.
Time frame: Assessed at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Anxiety
Measured through the General Anxiety Disorder-7 (GAD-7), a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Depression
Measured through the Patient Health Questionnaire-9 (PHQ-9), a 9-item scale (scores 0-27). Higher scores mean higher depression levels.
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Self-reported Quality of Life
Assessed through the question "On a scale of 0-100, how would you rate your overall health, with 0 being the worst health imaginable and 100 the best health imaginable?"
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Work productivity and absenteeism
Measured through Work Productivity and Activity Impairment Questionnaire (WPAI) assessed by the sub-scores: WPAI overall (combining presenteeism and absenteeism), WPAI work (presenteeism), WPAI time (absenteeism) and WPAI activities (activities of daily living impairment) (scores 0-100%). Higher scores mean greater impairment.
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Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Self-reported Fitness Level
Current fitness level measured through the question "How do you currently feel when performing physical activity?". Responses are rated on a 6-point ordinal scale: 1. Very Poor: I feel physically weak and struggle with basic physical activity; 2. Poor: I often feel tired and find physical activity challenging; 3. Fair: I feel average and can perform basic physical activity without much difficulty; 4. Good: I feel above average and can perform most physical activity with ease; 5. Very Good: I feel strong and energetic when performing challenging physical activity; 6 = Excellent: I feel extremely fit, performing strenuous physical activity with ease.
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Activity Level (IPAQ)
Measured through the International Physical Activity Questionnaire (IPAQ). The IPAQ records frequency and duration of walking, moderate-intensity activity, vigorous-intensity activity, and sedentary behavior over the previous 7 days. Responses are converted into metabolic equivalent (MET)-minutes per week and categorized as low, moderate, or high physical activity. Higher MET-minutes indicate greater levels of physical activity.
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Escalation of Care
Assessed through the question "Given the current status of your physical health, what is your likelihood of seeking out additional care/help to support your health or wellbeing?". Responses range from "Very unlikely" to "Very likely."
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Self-reported Weight
Self-reported body weight, recorded in pounds, at the time of assessment.
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Self-reported GLP-1 Usage
Assessed through the question "What is your experience with GLP-1 medications (e.g., Ozempic, Mounjaro)?"
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Pain (NPRS)
Measured by the Numerical Pain Rating Scale (NPRS) through the question "Please rate your average pain over the last 7 days" from 0 (no pain at all) to 10 (worst pain imaginable)".
Time frame: Assessed at baseline (upon initiation of the program) and then at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Heart Rate (wearable-measured)
Heart rate will be measured using a wearable device during engagement in physical activity. Measurements are recorded in beats per minute (bpm).
Time frame: Assessed continuously during physical activity sessions. Summarized at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Daily Step Count (wearable-measured)
Steps will be recorded using a wearable device as the total number of steps taken within each 24-hour period. Both total and average daily step counts will be calculated.
Time frame: Steps recorded daily. Outcomes summarized at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Sleep Duration (wearable-measured)
Sleep will be assessed using a wearable device, including the total number of minutes spent sleeping and/or in each sleep cycle. Average minutes spent sleeping and/or in each sleep cycle will also be calculated.
Time frame: Recorded daily. Outcomes summarized at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Daily Active Minutes (wearable-measured)
Physical activity time will be measured using a wearable device as the total minutes of activity per 24-hour period.
Time frame: Recorded daily. Outcomes summarized at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Behavior Change
Assessed through the question "How has your level of physical activity improved since starting the Move program?" Responses are rated on a 3-point ordinal scale: 1= Lower Activity: I'm still building my routine; 2= Moderate Activity: I'm noticing improvements and staying active a few days per week; 3= Higher Activity: I feel much more active and energized, participating in physical activities most days of the week.
Time frame: Assessed at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Physical Health Specialist Rating
Assessed through the question "How would you value your overall experience with your Physical Health Specialist?", with scores ranging from 1 to 5. Higher scores indicate greater experience.
Time frame: Assessed at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.
Move Plan Rating
Assessed through the question "How would you value your Move plan so far?", with scores ranging from 1 to 5. Higher scores indicate greater value.
Time frame: Assessed at regular intervals (after 5, 9, 15, and every 6 days with activity until 3 months). Additional follow-up assessments may be undertaken at other times: 3, 6, and 12 months.