NCT07179796Enrolling By Invitation不适用
Digital Physical Activity Programs: a Large Scale Prospective, Observational Study
Sword Health, SA1 个研究点 分布在 1 个国家目标入组 300,000 人开始时间: 2025年9月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300,000
- 试验地点
- 1
- 主要终点
- Member Progress (PGIC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Member Progress (PGIC)
时间窗: 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.
次要结局
- Anxiety(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(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 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(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(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)(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 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(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 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)(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)(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 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)(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)(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 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 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 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.)
研究者
研究点 (1)
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