Overall HealthNCT07179796
Digital Physical Activity Program
An observational study of Overall Health and Wellbeing, run by Sword Health, SA at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overall Health, Wellbeing, Quality of Life
- What is being tested?
- Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to Dec 2035
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: These programs will cover all participants interested in improving their health and wellness through increased physical activity.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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:
- Assess the adoption, engagement and feasibility of digital physical activity programs to increase physical activity and its subsequent effect on health and wellness;
- Assess the results of digital physical activity programs and compare the costs with the benefits obtained;
- 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;
- 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.
- Conditions
- Overall Health, Wellbeing, Quality of Life, Mental Health
- Being tested
- Observation
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation | These programs will cover all participants interested in improving their health and wellness through increased physical activity. Receives: Behavioral: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (17)
Anxiety
Measured through the General Anxiety Disorder-7 (GAD-7), a 7-item scale (scores 0-21). Higher scores mean higher anxiety levels.
Measured: 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.
Measured: 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?"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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)?"
Measured: 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)".
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start9 Sep 2025
- Primary completionSep 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando D Correia, MD, PhD, Principal investigator, SWORD HEALTH INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179796
- Sponsor's protocol ID
- SH-OBS-MV-US-01
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Physical Activity Programs: a Large Scale Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07179796
- Acronym / sponsor ID
- SH-OBS-MV-US-01
- Conditions
- Overall Health, Wellbeing, Quality of Life, Mental Health
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Assess the adoption, engagement and feasibility of digital physical activity programs to increase physical activity and its subsequent effect on health and wellness;
- Assess the results of digital physical activity programs and compare the costs with the benefits obtained;
- 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;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Behavioral: ObservationThese programs will cover all participants interested in improving their health and wellness through increased physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- These programs will cover all participants interested in improving their health and wellness through increased physical activity.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationPersonalized 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. | Behavioural | Observation |
Primary outcome
Member Progress (PGIC)
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.
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.
17 secondary outcomes
Anxiety
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
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
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
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
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)
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
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
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
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)
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)
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)
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)
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)
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando D Correia, MD, PhD principal investigator
SWORD HEALTH INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overall Health and Wellbeing, run by Sword Health, SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Member Progress (PGIC) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.