Technology to Support Exercise Adherence in Project EXCEL Participants
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- EXCEL class attendance
研究概览
简要总结
Exercise adherence and maintenance in the EXCEL program supported with a smart phone application: A pilot randomized controlled trial
详细描述
Purpose: The primary aim of this proposed pilot randomized controlled trial is to investigate the effectiveness and patterns of use of a mHealth application (ZoeInsights - ZI) for supporting physical activity (PA) maintenance in remote and rural cancer survivors within an online-delivered exercise oncology program (Project EXCEL; ethics HREBA-CC.20-0098).
Background/Rationale: Evidence indicates mixed effectiveness for online-delivered exercise oncology programs to improve physical activity (PA) behavior, especially with regards to maintenance of PA behavior post-intervention. Supportive resources are needed, especially for remote/rural cancer survivors who may have lower social support, PA self-efficacy, motivation, as well as unique barriers to PA. Mobile health technology (mHealth) has potential to support PA behavior change in cancer survivors, but evidence for its impact and best implementation practices in exercise oncology remains limited. Prior findings on PA behavior change suggest that in order to elicit lasting effects, early integration of supportive resources (eg. self-monitoring via a mhealth app) within PA participation is important. And in particular, research is needed to determine the effectiveness of mHealth within exercise oncology programs for supporting long-term PA maintenance. No studies on mhealth exercise interventions have been carried out in remote/rural cancer survivors.
Objectives: Primary aim is to assess the effectiveness of the mhealth app, ZI for supporting maintenance of PA behavior change, up to 24-weeks from program initiation. The impact of the ZI intervention on PA behaviour change will be measured by weekly objectively measured minutes of moderate to vigorous physical activity (MVPA), subjectively reported weekly minutes of MVPA, and program attendance. The investigators hypothesize the ZI intervention group will have improved maintenance of PA behavior change at 24-weeks compared to those in EXCEL only group. The secondary outcomes aim to assess the extent of use of the application. This will be assessed by app usage, satisfaction reports, and the participants perspectives on the continued use of the ZI application. The investigators hypothesize that majority of users will download and continue to use the application throughout the 24-week study period.
Methods:
Participants and Recruitment All EXCEL participants will be eligible to participate in the proposed sub-study, including those who may already be using PA-related apps. Email invitations will be sent to eligible participants with a study overview, instructions on who to contact to answer questions, and a link to complete the informed consent form in the EXCEL RedCap database if they are interested in participating. The consent form will require an electronic signature. It will be marked as complete in RedCap as soon as all required fields are completed and the participant submits the form. After completion of recruitment, randomization using a random number generator, with odd numbers assigned to the intervention (EXCEL + ZI at baseline) and even numbers to the waitlist control (EXCEL + ZI at 24 weeks) group. Randomization will occur by clusters so that all participants in the same exercise class day and time will be assigned to the intervention or waitlist control group. This will be done to enhance the integration of ZoeInsights within the EXCEL program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be unaware of the intervention the participants received. Due to the nature of the intervention (a eHealth application) participants can't be blinded to the intervention. Furthermore, due to the intention to integrate the application as part of extended support provided in the EXCEL program, exercise class instructors (care providers) will be made aware of participant group assignment. The research coordinator will also be aware of the intervention of each participant to aid in troubleshooting with the ZoeInsights application.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ZoeInsights Application Arm
Participants will receive free access to the ZI app for the 12-week intervention. After completing initial set-up, participants will be asked to record physical activity and symptoms regularly via scheduled in-app routines. Further use of ZI (eg. Custom daily routines, additional graphing, medication tracking, accessing linked health resources) during the intervention will be possible ad libitum. After the initial 12-weeks of the EXCEL+ZI intervention, participants have continued free access to the ZI app for up to 1 year.
干预措施: EXCEL Exercise Class (Behavioral)
ZoeInsights Application Arm
Participants will receive free access to the ZI app for the 12-week intervention. After completing initial set-up, participants will be asked to record physical activity and symptoms regularly via scheduled in-app routines. Further use of ZI (eg. Custom daily routines, additional graphing, medication tracking, accessing linked health resources) during the intervention will be possible ad libitum. After the initial 12-weeks of the EXCEL+ZI intervention, participants have continued free access to the ZI app for up to 1 year.
干预措施: ZoeInsights Application (Device)
Waitlist control
During the 12-week intervention the participants will only take part in an online delivered EXCEL exercise class and will not have access to the ZI app. After completion of the 24-week test, the participants will be granted access to the ZI app.
干预措施: EXCEL Exercise Class (Behavioral)
结局指标
主要结局
EXCEL class attendance
时间窗: Potential class data in EXCEL baseline and maintenance classes will be recorded, and input into REDCap, from week 1-12 (baseline); and 12-24 (maintenance, optional)
Class attendance (up to 2 x per week) during weeks 1-12 will be recorded by the EXCEL class lead, and input into REDCap. In addition, attendance at subsequent EXCEL maintenance programs (up to week 24) will be recorded
Objective Physical Activity Minutes Per Week
时间窗: Measured continuously from baseline to 24 weeks
Change in activity levels from pre to post; Number of participants meeting Guidelines for Physical Activity of 90 minutes per week of moderate to vigorous intensity exercise, based on accelerometer data from commercially-available activity tracker. For the activity tracker each minute in the 55-70 percent age predicted HRmax will be evaluated as moderate intensity and above 70 percent of HRmax will be evaluated as vigorous intensity. Vigorous intensity minutes of physical activity will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes.
Subjective Physical Activity Minutes Per Week
时间窗: Self-reported at baseline, week 4, week 12, and week 24
Change in Physical Activity minutes per week, based on modified Godin Leisure Time Exercise Questionnaire (mGLTEQ). In the mGLTEQ all dimensions (strenuous exercise, moderate exercise, mild exercise, resistance training, and flexibility) will be looked at separately and weekly minutes will be calculated by multiplying duration times frequency of sessions. Vigorous intensity minutes of exercise will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes. Higher scores are better, indicating more minutes of MVPA were accumulated.
次要结局
- Lower extremity flexibility(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- ZI application usage(Continuous measurement from baseline to 24 weeks)
- Upper extremity flexibility(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Balance(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Cancer related symptoms(Assessed at baseline and weeks 4, 8, 12, 16, 20, 24)
- Fatigue(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- General well-being(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Cognition(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Participant Satisfaction(Completed at week 4, 12, and 24)
- Aerobic Endurance(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Upper extremity grip strength(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Body Composition(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Functional performance test(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Barriers and facilitators to exercise participation(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Exercise adherence(Continuous measurement from baseline to 24 weeks)
- General Health-related Quality of Life(Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up))
- Participant perceptions of using the ZI application(At 12 and 24 weeks)