My Back Exercise App - A mobile application for people with chronic non-specific low back pain.

This multi-arm multi-stage trial will comprise five study arms, including one control group and four intervention groups. All participants will receive access to the “My Back Exercise” App, with specific access to different intervention components according to the participant’s allocation. Recruitment and enrolment will commence at the same time for all study arms. After enrolment and completion of the 6-week intervention program by 1/3 of the estimated sample size, an interim analysis will be conducted. The outcome of the interim analysis will allow dropping intervention arms that are deemed futile, in accordance with pre-specified decision rules. There will be no introduction of new arms into the study. The overall duration of the study is one year after randomisation. Study Arms: - Intervention Group 1: Education + Notifications + Exercise. - Intervention Group 2: Education + Notifications + Exercise + Sleep. - Intervention Group 3: Education + Notifications + Exercise + Diet. - Intervention Group 4: Education + Notifications + Exercise + Sleep + Diet. Intervention Components: Exercise Module: - Content: A 6-week, automated, home-based, tailored exercise program, generated based on the participant’s self-reported functional level, as measured by a modified version of the Patient-Specific Functional Scale (PSFS). The exercise program will include up to three exercises and three additional options for swapping. Each week, three new exercises will replace previous ones. The dosage of the resistance training according to difficulty level was established based on the American College of Sports Medicine (ACSM) and the International Exercise Recommendations in Older Adults. A total of 8-12 repetitions will be recommended for isotonic exercises and 10-30 seconds hold for isometric exercises; three sets; three times a week; at an exercise intensity of 7-9 in all programs, as rated on the 11-point scale of Rating of Perceived Exertion (RPE). A graded approach to progression in intensity and complexity of the exercises will be adopted. The content of the exercise module has been designed specifically for this study and includes strengthening and flexibility exercises. The exercises will involve bodyweight only, and some of them may require minimal equipment (e.g., a mat, chair, table, step, pillow, handrail or wall for support). Examples of strengthening exercises include planks, squats, lunges, push-ups, and curl-ups. Examples of flexibility exercises include trunk, hamstrings, piriformis, and quadriceps stretching. - Frequency and Duration: Participants will be recommended to complete their exercise program at least three days per week across the 6-week exercise program, totalling 18 exercise sessions. There will be no distinction among intervention groups. Considering that the exercise program should be performed three times a week and each exercise session should take approximately 20 to 30 minutes, completing the exercise module should take approximately 60 to 90 minutes per week for 6 weeks. Education Module: - Content: A 6-week intervention containing written information, audio tracks, and links to online resources providing information about the nature of non-specific LBP, symptoms, evidence-based treatments, pain management, frequently asked questions about LBP, and guidance to assist participants in increasing their physical activity level. The content of the educational module has been designed specifically for this study and is complemented with links to additional, online, readily available resources (e.g., Australian Government - Health Direct, Australia Physiotherapy Association, Musculoskeletal Australia, and scientific references). - Frequency and Duration: Every week, new content will be made available (i.e., unlocked) and participants will be recommended to complete the weekly content at their convenience. Completing the education module should take approximately 10 to 30 minutes per week for 6 weeks. Sleep Module: - Content: A 4-week tailored sleep education program containing written information, audio tracks, and links to online resources providing information about sleeping habits, sleep efficiency, how sleep and LBP are connected, and how to optimise sleep and improve overall well-being. Participants will be given hints, tips and personalised goals on how to improve their sleeping habits through relaxation training and stimulus control. The content of the sleep module has been designed specifically for this study with advice from researchers in the sleep field. - Frequency and Duration: Once a week, participants will be asked to review sleep information and choose a goal for the week. This should take approximately 5 minutes. Once a day, participants will be sent a reminder to work on their goal. This should take approximately 2 to 10 minutes depending on the goal they choose. Completing the sleep module should take approximately 10 to 15 minutes per week for 4 weeks. Diet Module: - Content: A 6-week intervention containing written information, audio tracks, and links to online resources providing information about the basics of nutrition, including food groups, ultra-processed foods, the impact of sugar on health, the role of antioxidants, and how to integrate suitable nutrition into the lifestyle and boost their overall well-being. Participants will be offered weekly tasks on how to read nutrition labels, make healthier food choices, and use food as a coping strategy to self-manage their chronic pain. The content of the diet module has been designed specifically for this study and is complemented with links to additional, online, readily available resources (e.g., Australian Government - Eat for Health / Eating Well, NSW Government - Food Authority, and scientific references). The content is strictly educational, encouraging participants to adopt healthier eating habits. No recommendations will be made regarding specific diets, and no meal plans or recipes to follow will be provided. - Frequency and Duration: Every week, new content will be made available (i.e., unlocked) and participants will be recommended to complete the weekly content at their convenience. Completing the diet module should take approximately 10 to 30 minutes per week for 6 weeks. Automated Push Notifications: - Content: Participants will receive lifestyle-based self-management push notifications providing encouragement, advice, and motivation, as well as information about LBP, and tips about exercise, physical activity, sleep, diet, mood, and use of care and medication. Each notification will be approximately 160 characters in length and will include the name of the App. The content of the push notifications has been adapted from a previous study (TEXT4myBACK; ACTRN12618001263280), where a bank of text messages was developed for people with LBP. - Frequency and Duration: Participants will receive up to 4 notifications per week for 6 weeks in random time slots at 9 am, 12:30 pm, 4 pm, and 6 pm. There will be no distinction among intervention groups. Strategies to Monitor Adherence: To measure adherence to the exercise and sleep modules (which offer tailored content), participants will be prompted to complete a self-reported activity tracker within the My Back Exercise App. To measure adherence to the education and diet modules, participants will be prompted to complete an electronic logbook through REDCap weekly. Additionally, app use and engagement will be collected in a de-identified format using data analytics, drawn from the app’s backend system (e.g., frequency of use, time spent, content accessed). There will also be a brief interview/survey by email or phone call at 6 and 9 months after randomisation to follow-up adherence and engagement with the app. Adherence will be calculated for each study arm and the entire study considering the self-reported number of completed exercise sessions expressed as a proportion of the total prescribed exercise sessions. Adherence will be considered acceptable when participants complete at least 70% of their prescribed exercise program.