Digital Physical Activity Program

NCT ID: NCT07179796

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 300000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2035-12-31

Brief 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. 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:

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.

Conditions

Overall Health; Wellbeing; Quality of Life; Mental Health

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation

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

Observation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sword Health, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando D Correia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

SWORD HEALTH INC

Locations

Sword Health

New York, New York, United States

Countries

United States

Other Identifiers

SH-OBS-MV-US-01

Identifier Type: -

Identifier Source: org_study_id