Exercise intervention for people with systemic sclerosis: A randomised waitlist controlled trial

Intervention group (structured exercise) This will be a 12 week structured exercise program conducted in conjunction with usual care, consisting of up to 60 minutes of moderate-to-vigorous intensity aerobic exercise and progressive resistance training, supervised 2 times per week. The supervised sessions can either be in-person at the Charles Perkins Centre RPAH gym or via Telehealth (‘real-time’). It is encouraged to have at least 1 session in-person, if possible. Participants will also be advised to perform one independent exercise session which will be supported by pre-recorded exercise videos and an individualised exercise program done on ‘physiapp’. The overall exercise program will be prescribed by Dr Stephanie Frade, an accredited Exercise Physiologist (AEP), and supervised by appropriately trained AEPs or exercise scientists. In-person supervised exercise sessions (Charles Perkins Centre RPAH gym) Participants will commence with a 5 minute seated mobility sequence, followed by aerobic and resistance based exercises. The aerobic component will involve interval-based training on a recumbent cycle ergometer. Exercise intensity will be individualised based on each participant’s percentage HRpeak or peak power output measured during the baseline CPET. Aerobic exercise intensity will be monitored using the BORG RPE scale and a polar heart rate monitor. These values will be used to adjust exercise workloads to ensure participants are exercising within the prescribed intensity zones of moderate to vigorous. The intervals will follow the 10 x 1 minute high intensity interval training (HIIT) protocol, where participants will work at ‘high intensity’ for 1 minute (70% HRpeak to <85%peak, or 70 to <85% peak power output, or equivalent to an RPE of 16 to 19 out of 20, interspersed with a ‘low intensity' interval for 1 minute (40% HRpeak to <55%, or 40 to <55% of peak power output, or equivalent to an RPE of 11 to 13 out of 20. In the first week, participants will aim to complete a total of 4 rounds, equating to a total work time of 8 minutes, and the number of rounds will progress over the course of the 12-weeks, building up to 10 rounds, equating to a total work time of 20-minutes. Overall exercise intensity and volume will be progressed over the 12-weeks as tolerated and can be up or down titrated throughout the 12-weeks depending on RPE. All aerobic sessions will include a 2 to 3 minute light intensity warm-up and 1 to 2 minute cool down, equivalent to an RPE of 7 to 11 out of 20. The resistance component will include 6 to 8 compound exercises (examples include seated push, seated pull, bicep curls, sit to stands, marching on the spot, rotation etc) focusing on major muscle groups to improve muscle strength. The dosage will include 1 to 3 sets of 8 to 15 repetitions performed at 55 to <70% of their 1RM measured during baseline testing (equivalent to 12 to 15 out of 20, with 1 to 2 minute rest between sets. The intensity will progressively increase over the course of the 12-week program, aiming to work up to 70 to <85% of their 1RM (equivalent to 16 to 19 out of 20) with 1-to-2-minute rest between each set. Overall exercise intensity and volume will be progressed over the 12-weeks as tolerated and can be up or down titrated throughout the 12-weeks depending on RPE. Technique will be closely monitored, and participants will be encouraged to perform the movements with control (rather than relying on momentum, for example). Telehealth-supervised exercise sessions Participants will complete a multimodal home-based exercise sessions supervised in “real time” on Microsoft Teams. As such, participants will be closely supervised throughout the exercise session by an exercise professional who will be able to provide feedback and correction in real time. The aerobic component will involve interval-based training on a recumbent cycle ergometer which will be provided to the participants. Aerobic exercise intensity will be monitored using the BORG RPE scale. The intervals will follow the 10 x 1 minute high intensity interval training (HIIT) protocol, where participants will work at ‘high intensity’ for 1 minute (RPE of 16 to 19 out of 20), interspersed with a ‘low intensity' interval for 1 minute (RPE of 11 to 13 out of 20). In the first week, participants will aim to complete a total of 4 rounds, equating to a total work time of 8 minutes, and the number of rounds will progress over the course of the 12-weeks, building up to 10 rounds, equating to a total work time of 20-minutes.The resistance component will be structured as a circuit, with 6 to 8 exercises. The dosage will include 8 to 12 reps of each exercise, performed in 1 to 3 sets. All exercises will be functional movements that are replicable of activities of daily living such as push, pull, squat, lunge, locomotion, and rotation, using either their own body weight, exercise apparatus such as a cycle ergometer, Thera Bands, and/or handheld weights which the research team will provide to participants to keep. The telehealth exercise sessions will be moderate to vigorous intensity, with an RPE of 12 to 15 out of 20 for moderate intensity and 16 to 19 out of 20 for vigorous intensity, which will be monitored through-out the exercise program using the RPE scale, consistent with the clinic gym session. During the telehealth sessions, exercise progressions will be made based on the participant’s RPE and according to the exercise professional’s discretion. All telehealth sessions will include a 5-min warm up and cool down (RPE of 7 to 11 out of 20), including dynamic and static stretches and breathing. To ensure participants are safely exercising during the telehealth-supervised exercise sessions, all participants would have completed the ESSA pre-screening tool prior to commencing the intervention, and the research team will have an information sheet with the participants’ details (phone number, home address, emergency contact details), should this be required in the event of an emergency. Independent home exercise sessions For independent home exercise, participants will be sent an individualised home exercise program using ‘PhysiApp’, a telehealth platform where participants can access an individually prescribed home exercise program either via printed handouts, ‘PhysiApp’ app, or web browser using a code sent to their email. We will also provide participants with pre-recorded videos of example exercise sessions that they can also do independently in their own time. These videos can be access through a private YouTube channel which we will provide to participants. To complement their home exercise, the research team will provide participants with a cycle ergometer, weights and TheraBands, and a gym floor mat to keep so that they can perform a similar session to that prescribed in the gym and continue with independent exercise long-term. Exercise Education Our trial includes an educational component that is directly embedded into the exercise intervention. Throughout the supervised sessions, the supervising AEP will provide individualised instruction on safe exercise technique, the use of rating of perceived exertion scales and heart rate to gauge and adjust intensity as needed, and strategies for modifying exercises to suit participants’ home environments and daily fluctuations in symptoms. Education will also focus on how to incorporate physical activity into weekly routines in a way that supports fatigue management and their individual lives. Participants will be encouraged to perform 1 additional independent exercise session alongside the 2 supervised sessions which will be supported by a set of guided exercise videos (accessed via a private YouTube channel) and a laminated “10 essential exercises” resource, along with basic home exercise equipment. This will be given to participants at the start of the intervention and is theirs to keep. The AEP will reinforce key messages each week and ask participants what exercise and physical activity they have achieved to help participants gradually progress toward consistent independent exercise and a daily step goal of up to 10,000 steps by the end of the 12-week intervention. This embedded education will be done through conversation during the supervised sessions, which is reflective of AEP clinical practice. This education ensures that participants not only complete the supervised exercise safely and effectively, but also develop the skills needed to continue exercising confidently beyond the trial. Following the 12 week intervention, all participants will be educated on ways to continue or start community-based exercise (Examples include: Active and Healthy, Exercise Right, Health for life program). Usual care (wait-list control group) Participants in the control group will be asked to continue with their usual care for the 12 week intervention period; we will not ask control participants to stop their usual exercise routines, nor will we prescribe any new exercises or refer them to community based exercise. Control participants will also be wearing the Axivity activity monitor periodically throughout the study period to track their levels of physical activity. This device is to be worn for a total of 7 days at various timepoints. Note that this activity monitor does not provide participants any feedback and therefore does not affect their usual care. At the completion of the study period, control participants will be offered the opportunity to complete the 12 week exercise program. Control participants will perform selected assessments at the end of the 12 week exercise program to evaluate the effectiveness of the exercise program.