None listed
Conditions
Brief summary
This is a randomised wait-list control study. Participants will be randomised to participate in either a structured, individualised, supervised exercise program (intervention group) or to usual care (wait-list control group). Participants allocated to the intervention group will complete a 12 week, 3 times per week, structured, individualised, 1 on 1 supervised exercise program (mixed between face to face and "live" telehealth on Microsoft teams). Participants allocated to the control group will continue with their usual care over the 12 week period and then be invited to receive the full 12 weeks intervention on completion of the 36 weeks follow up assessment period. Blinded assessments will be undertaken at baseline (week 0), following the intervention (Week 12), and at follow-up (36 weeks).
Interventions
This is a randomised wait-list control study. Participants will be randomised by an independent researcher in a 1:1 ratio to participate in a structured, individualised, supervised exercise program (intervention group) in conjunction with their usual care or to usual care alone (wait-list control group). Usual care for people with myositis may include continuation of their pharmacological treatment, attendance to their usual medical appointments, and continuation of their usual day-to-day activities (for example, their usual exercise routine or hobbies). Participants allocated to the intervention group will complete a 12 week (3 sessions per week, 45 to 60 minute session) structured, individualised, supervised exercise program. These sessions which will be undertaken in the Royal Prince Alfred Hospital Clinic at the Charles Perkins Centre face-to-face at least once per week, with at least one session per week administered via telehealth (supervised “live” on Microsoft Teams), and the remaining one session per week administered face-to-face or via telehealth based on participant preferences. The exercise program will be prescribed by an experienced Accredited Exercise Physiologist (minimum of 10 years of experience), and all exercise sessions will be supervised 1 on 1 by an appropriately trained exercise professional (accredited exercise physiologist and/or accredited exercise scientist) The exercise program will include a combination of aerobic and resistance exercises and will be individually progressed from moderate to vigorous intensity over the 12 weeks, according to rating of perceived exertion (6 to 20 BORG scale for aerobic exercise; 0 to 10 BORG scale for strength exercise, "higher numbers = higher intensity") and heart rate response (using polar heart rate straps). The face-to-face exercise program will commence with a 5 minute dynamic warm up (body weight mobility and strength, replicating the strength based exercises) and a 5 minute light intensity cycle on a reclined cycle ergometer. The aerobic exercise component will include a 10 x 1 high intensity interval training (HIIT) protocol, which involves 1 min at "high intensity" and 1 min at "low intensity", for 4 to 10 rounds (progressing to 10 rounds over the 12 weeks). The resistance exercise component will include 6 to 8 compound strength exercises, with a load range of 8 to 10 repetition and 2 to 3 sets, and using a combination of Keiser machine weights and free weights. Examples of exercises include seated chest press, seated latissimus pull down, seated leg press, standing bicep curls, sit-to-stands or squats, and/or seated low pull. The telehealth exercise sessions will include a 10 minute dynamic warm up (body weight mobility and strength, replicating the aerobic and strength based exercises), followed by a circuit of 6 to 8 compound aerobic and strength exercises using either time (up to 1 minute) and/or load ranges of 8 to 10 reps and 2 to 3 sets. Examples of exercises include standing bicep curls, standing marches, bent over rows, sit-to-stands, and/or aerobic type movements such as step together and high knees. Adherence to the exercise sessions will be done by marking attendance to the exercise sessions and whether the session was telehealth or face-to-face. The exercise program will also include education about the benefits of exercise, how to exercise safely, and ways to incorporate exercise in day-to-day life. The education will involve open-ended discussions done throughout the exercise intervention (i.e. before/during/after the exercise sessions). We will also provide participants with videos and/or fact sheets with exercise guidelines and takeaway home exercises.
This is a randomised wait-list controlled trial. Participants will be randomised by an independent researcher in a 1:1 ratio to participate in a structured, individualised, supervised exercise program (intervention group) in conjunction with their usual care or to usual care alone (wait-list control group). Usual care for people with myositis may include continuation of their pharmacological treatment, attendance to their usual medical appointments, and continuation of their usual day-to-day activities (for example, their usual exercise routine or hobbies). Participants allocated to the intervention group will complete a 12 week (up to 3 sessions per week, approx. 60-minute session) structured, individualised, supervised exercise program. These sessions which will be undertaken in the Royal Prince Alfred Hospital Clinic at the Charles Perkins Centre face-to-face and via telehealth (supervised “live” on Microsoft Teams), based on participant preferences and availability. The exercise program will be prescribed by an experienced Accredited Exercise Physiologist (minimum of 10 years of experience), and all exercise sessions will be supervised 1 on 1 by an appropriately trained exercise professional (accredited exercise physiologist and/or accredited exercise scientist) The exercise program will include a combination of aerobic and resistance exercises and will be individually progressed from moderate to vigorous intensity over the 12 weeks, according to rating of perceived exertion (6 to 20 BORG scale for aerobic exercise; 0 to 10 BORG scale for strength exercise, "higher numbers = higher intensity") and heart rate response (using polar heart rate straps). The face-to-face exercise program will commence with a 5 minute dynamic warm up (body weight mobility and strength, replicating the strength based exercises) and a 5 minute light intensity cycle on a reclined cycle ergometer. The aerobic exercise component will include a 10 x 1 high intensity interval training (HIIT) protocol, which involves 1 min at "high intensity" and 1 min at "low intensity", for 4 to 10 rounds (progressing to 10 rounds over the 12 weeks). The resistance exercise component will include 6 to 8 compound strength exercises, with a load range of 8 to 10 repetition and 2 to 3 sets, and using a combination of Keiser machine weights and free weights. Examples of exercises include seated chest press, seated latissimus pull down, seated leg press, standing bicep curls, sit-to-stands or squats, and/or seated low pull. The telehealth exercise sessions will include a 10 minute dynamic warm up (body weight mobility and strength, replicating the aerobic and strength based exercises), followed by a circuit of 6 to 8 compound aerobic and strength exercises using either time (up to 1 minute) and/or load ranges of 8 to 10 reps and 2 to 3 sets. Examples of exercises include standing bicep curls, standing marches, bent over rows, sit-to-stands, and/or aerobic type movements such as step together and high knees. Adherence to the exercise sessions will be done by marking attendance to the exercise sessions and whether the session was telehealth or face-to-face. The exercise program will also include education about the benefits of exercise, how to exercise safely, and ways to incorporate exercise in day-to-day life. The education will involve open-ended discussions done throughout the exercise intervention (i.e. before/during/after the exercise sessions). We will also provide participants with videos and/or fact sheets with exercise guidelines and takeaway home exercises.
Sponsors
Study design
Eligibility
Inclusion criteria
Greater than or equal to 18 years of age Diagnosis of dermatomyositis, polymyositis or immune-mediated necrotizing myopathy (IMNM), made by a medical practitioner, and in accordance with European league against rheumatism (EULAR)/American college of rheumatology (ACR) Classification Criteria for Adult and Juvenile Idiopathic inflammatory myopathy (IIM) and their Major Subgroups (High probability more than 55% on calculator for IIM). Disease duration greater than 3months History of significant muscle inflammation (myositis) that has impacted health and been a major consideration in treatment decisions as judged by the treating physician Willingness to provide informed consent and willingness to participate and comply with the study requirements Deemed safe to exercise according to the Exercise and Sport Science Australia (ESSA) pre-screening form and baseline clinical assessments
Exclusion criteria
Less than 18 years of age Inclusion Body Myositis (IBM) Amyopathic Dermatomyositis (ADM) Contraindication or inability to exercise as determined by the ESSA pre-screening form and baseline clinical assessments Currently pregnant or planning pregnancy Diagnosis of condition(s) that may limit ability and safety to perform exercise (e.g., unstable cardiovascular disease, uncontrolled congestive heart failure, known heart failure) Active malignancy Severe interstitial lung disease (ILD) with a diffusing capacity of the lungs for carbon monoxide (DLCO) <40% and/or a forced vital capacity (FVC) less than 60% Renal impairment (estimated glomerular filtration rate (GFR) less than 30mL/min/1.73m2)