Digital Physical Activity Program

Digital Physical Activity Programs: a Large Scale Prospective, Observational Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Wellbeing; Mental Health; Overall Health
• Intervention / Treatment: Behavioral: Observation

Detailed Description

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 (Estimated): 300000

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Sword Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

These programs will cover all participants interested in improving their health and wellness through increased physical activity.

Description

Inclusion Criteria:

• healthy individuals, or individuals with pre-existing conditions who are able to perform unsupervised exercise, unless contraindicated by their treating physician;
• older than the age of majority in their state of residence (US based);
• participant is able to understand study procedures and willing to provide informed consent.

Exclusion Criteria:

• younger than the age of majority in their state of residence;
• pain scores exceeds 6/10 on an 11-point numerical rating scale or member reports irregular movement patterns;
• undergone a surgical procedure within the last three months;
• presence of exertional red flags, as defined by the American College of Sports Medicine, and the participant has not been cleared to engage in an unsupervised exercise based program by their treating physician;
• health condition incompatible with an unsupervised exercise based program that has not been cleared by their treating physician;
• active cancer diagnosis, or is receiving treatment for cancer, and not been cleared by their treating physician to engage in an unsupervised exercise program;
• history of unexplained falls or utilization of an assistive device and has not been cleared by their treating physician to engage in an unsupervised exercise program;
• currently pregnant and has not been cleared by their treating physician to engage in an unsupervised exercise program;
• cognitive condition that prevents participant from understanding and independently executing an unsupervised exercise program.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation; These programs will cover all participants interested in improving their health and wellness through increased physical activity.	Behavioral: Observation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Measured through the General Anxiety Disorder-7 (GAD-7), a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.	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.	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?"	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.	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: Very Poor: I feel physically weak and struggle with basic physical activity;; Poor: I often feel tired and find physical activity challenging;; Fair: I feel average and can perform basic physical activity without much difficulty;; Good: I feel above average and can perform most physical activity with ease;; Very Good: I feel strong and energetic when performing challenging physical activity; 6 = Excellent: I feel extremely fit, performing strenuous physical activity with ease.	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.	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."	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.	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)?"	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)".	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).	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.	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.	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.	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.	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.	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sessions performed	Number of total exercise sessions performed	Through study completion, an average of 3 months
Total Physical Activity Time	Number of minutes spent on exercise sessions (aggregated).	Through study completion, an average of 3 months
Average Physical Activity Time per Week	Average number of minutes spent on exercise per week	Through study completion, an average of 3 months
Self-reported satisfaction	Measured through the Net Promoter Score question collected at end of program: "On a scale from 0 to 10, how likely are you to recommend SWORD's programs to a friend or family member?")	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.

Collaborators and Investigators

• Sponsor: Sword Health, SA
• Investigators: Principal Investigator: Fernando D Correia, MD, PhD, SWORD HEALTH INC

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: September 17, 2025
• First Posted (Estimated): September 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: SH-OBS-MV-US-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No