Menu
Enrolling by invitation NCT07179796

Digital Physical Activity Program

Observational Overall Health Wellbeing Quality of Life Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation.
Who it may be relevant to
Registry conditions: Overall Health, Wellbeing, Quality of Life, Mental Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Sword Health — New York

Identifiers

NCT: NCT07179796 · SH-OBS-MV-US-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗