Investigating the effect of an exercise and education intervention on mental health, quality of life and pain in people living with osteoporosis.

A combined exercise and education intervention for people with osteoporosis (OP). Arm 1: Pilates plus education group Arm 2: Combined Pilates and Progressive Resistance Training (PRT) plus education group. Arm 3: Waitlist control group This study will be a community based, multi-armed randomised controlled trial using parallel group design and single blinding (outcomes assessor). Participants will be recruited on a rolling basis. Randomisation will be completed after the initial baseline assessments by an independent researcher from the School of Health Sciences via a computer-generated randomisation scheme (www.randomization.com). Allocation will be concealed via placement of sequential group assignments into opaque sealed envelopes prepared by the independent researcher and handed to the participant for opening by the Accredited Exercise Physiologist (AEP). Participants will be randomised to either a Pilates plus education group (Arm 1), a combined Pilates and PRT plus education group (Arm 2) or a waitlist control group (treatment as usual) (Arm 3). Participants randomised to the group intervention will attend two in-clinic sessions per week, each lasting 60 minutes comprising approximately 45-50 minutes of exercise and 10-15 minutes of education in the UNSW Lifestyle Clinic gym. These sessions will be held weekly from weeks 1 to 12 inclusive. Participants will also be asked to undertake one unsupervised home exercise session per week, following a program which will be designed for them by an AEP in their in-clinic sessions. Participants will be asked to complete an exercise log documenting session completion, duration, intensity, and any other weekly physical activity, which they will present to the AEP during their weekly sessions to monitor progress and adherence to the overall program, provide support, and adjust the exercise programs where required (e.g., progress or regress intensity based on participant documentation of Rating of Perceived Exertion (RPE) and completion). If participants miss a scheduled in-clinic session, they will be given the opportunity to attend a make-up session where available. Adherence to the exercise interventions and any difference between groups will be reported on at completion of the trial. The program will be delivered and overseen by AEPs in the UNSW Lifestyle Clinic (Level 2, Health Translation Hub, Cnr High St & Botany St, Randwick NSW). Arm 1: Pilates plus education group. This group will undergo an initial assessment (Week 0), before commencing 24 group face-to-face exercise sessions, plus 12 individual home exercise sessions. Frequency: 3 times per week (twice weekly group sessions, once weekly individual home sessions; week 1 – 12), Duration: 60 minutes, Structure: Pilates exercise (approximately 45-50 minutes) and education (approximately 10-15 minutes). They will be assessed at the end of the intervention (Week 13-14). The Pilates group will follow a progressive Pilates training protocol based on previous randomised controlled trials (Oksuz & Unal, 2017, doi: 10.1016/j.ctcp.2016.12.001, Angin, Erden & Can, 2015. doi: 10.3233/BMR-150604) designed to target all muscle groups. Initial assessments with an AEP will determine an appropriate starting level for each participant. Each session will be 45-50 minutes in duration, including a 5-minute dynamic warm up and 5-minute cool-down at the end of the session. Exercises will be selected that participants are able to perform safely and effectively, with supervision provided for each of the sessions. Intensity of training will be set and monitored using the Borg 6-20 scale of perceived exertion (Borg,1982), with a target of moderate to somewhat hard (12-14 / 20). Progression will be determined on an individual basis by the AEP, and exercises may progress in intensity based on load, duration or complexity (e.g. closed chain to open chain exercises). An outline of the Pilates prescription is included below: Pilates Frequency 3xwk Intensity Moderate – somewhat hard, RPE 5-6/10 Type Mat-based (body-weight, bands, light dumbbells), with a preference for standing work (e.g. Lunge, scooter, squat, tabletop toe tap, glute bridge) Duration 45-50 minutes Repetitions 15-20 Progression Progress in complexity from closed to open-chain exercises Participants will also receive education regarding OP and exercise in the form of in-person education sessions delivered verbally and supported by short PowerPoint presentations at the end of their exercise sessions as part of the intervention. These will be supplemented with take-home resources including flyers which can be provided electronically if preferred. Education components will be based on the Healthy Bones Australia Exercise and Bone Density guidelines (Healthy Bones Australia, 2021), and will include the following topics: 1) The role of exercise in management of OP 2) Current exercise recommendations for people living with OP 3) Exercises to avoid for people living with OP 3) The role of exercise in falls prevention for people with OP During weekly sessions, the AEP will provide clients with a home exercise program based upon resources they have at home (e.g. body weight, dumbbells, bands) to be completed once weekly throughout the intervention. Participants will be asked to complete an exercise tracking diary to monitor these home sessions which they will be asked to bring to their in-person AEP sessions in order to check for completion and modify or progress where necessary. Participants will also receive materials regarding exercise they can complete at home for OP, including diagrams and text explanations of each exercise using Physitrack. Arm 2: Combined Pilates and PRT plus education group. This group will undergo an initial assessment (Week 0), before commencing 24 group face-to-face exercise sessions, plus 12 individual home exercise sessions. Frequency: 3 times per week (twice weekly group sessions, once weekly individual home sessions; week 1 – 12). Duration: 60 minutes, Structure: Pilates and progressive resistance training exercise (approximately 45-50 minutes) and education (approximately 10-15 minutes). They will be assessed at the end of the intervention (Week 13-14). This group will follow a combined Pilates and PRT protocol based on evidence-based guidelines for OP, designed to target all muscle groups. Initial assessments with an AEP will determine an appropriate starting level for each participant. Each session will be 45-50 minutes in duration, including a 5-minute dynamic warm up and 5-minute cool-down at the end of the session. A mix of weight machines and free weights will be used, depending on individual capability. Sessions will include both Pilates exercises (mat-based, with a preference for standing work) and PRT. Exercises will be selected that participants are able to perform safely and effectively, with supervision provided for each of the sessions. Intensity of training will be set and monitored using the Borg 6-20 scale of perceived exertion, with a target of moderate to somewhat hard (12-14 / 20). Progression will be determined on an individual basis by the AEP, and exercises may progress in intensity based on load, reps or complexity. During weekly sessions, the AEP will provide clients with a home exercise program based upon resources they have at home (e.g. body weight, dumbbells, bands) to be completed once weekly throughout the intervention. Participants will be asked to complete an exercise tracking diary to monitor these home sessions which they will be asked to bring to their in-person AEP sessions in order to check for completion and modify or progress where necessary. An outline of the Pilates and PRT exercise prescription is provided below: Combined Pilates & Progressive Resistance Training Frequency 3xwk (2 in-clinic, 1 at home) Intensity Aim to progress PRT to 75-85% of 1 Repetition Maximum (1RM) or 5 to 8 (hard to very hard) on Borg 0-10 RPE scale. Pilates will be performed at a target intensity of 5-6 (moderate to somewhat hard) on Borg 0-10 RPE scale. Type Pin-loaded weight plate machines (e.g. Leg Press, Leg Extension, Leg Curl, Seated row, Back extension, Chest Press, Lat Pulldown), body weight, free weights (e.g. Squat, deadlift, impact loading e.g. heel stomps), exercise bands. Mat-based Pilates (body-weight, bands, light dumbbells), with a preference for standing work (e.g. Lunge, scooter, squat, tabletop toe tap, glute bridge) Duration 45-50 minutes (2 in-clinic, 1 at home) Sets 2-3, rest 1-2 minutes between sets Repetitions 5-8 (PRT), 15-20 (Pilates) Volume sets x reps x days Progression Progress to 75-85% of 1RM or 5 to 8 on Borg 0-10 RPE scale. Pilates will progress in complexity from closed to open-chain exercises. *Higher intensity and fracture risk requires supervision. Participants will also receive education regarding OP and exercise in the form of in-person education sessions delivered verbally and supported by short PowerPoint presentations at the end of their exercise sessions as part of the intervention. These will be supplemented with take-home resources including flyers which can be provided electronically if preferred. Education components will be based on the Healthy Bones Australia Exercise and Bone Density guidelines (Healthy Bones Australia, 2021), and will include the following topics: 1) The role of exercise in management of OP 2) Current exercise recommendations for people living with OP 3) Exercises to avoid for people living with OP 3) The role of exercise in falls prevention for people with OP Participants will also receive materials regarding exercise they can complete at home for OP, including diagrams and text explanations of each exercise using Physitrack. Health outcomes will be assessed between intervention/control, intervention/intervention and baseline/follow-up. Educational materials will be delivered to both intervention groups throughout the duration of their intervention, and to the waitlist control group once they commence their intervention period. All participants will be provided with access to educational resources regarding exercise and osteoporosis following participation in the trial. Education provided will be based on Healthy Bones Australia guidelines for exercise prescription to support the management of osteoporosis (https://healthybonesaustralia.org.au/wp-content/uploads/2024/02/hba-ex-presc-final-compressed.pdf), with materials provided to participants from the Healthy Bones Australia Exercise and Bone Density guidelines (https://healthybonesaustralia.org.au/wp-content/uploads/2022/10/hba-exercise-brochure.pdf). Adherence If participants miss a scheduled session, they will be given the opportunity to attend a make-up session where available. Adherence to the exercise interventions and any difference between groups will be reported on at completion of the trial. Adherence will be measured in three ways: attendance records via clinician completed treatment logs, an exercise diary for home exercise sessions, and an Exercise Adherence Scale (EARS). Number of sessions attended and intensity measures will be recorded for all participants.