PolymyositisHIITmyositisNCT03324152
Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositis
A study testing High-intensity interval training (HIIT) - myositis, Standard low-intensity home exercise and High-intensity interval training (HIIT) - healthy in people with Polymyositis and Dermatomyositis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Polymyositis and dermatomyositis are rare inflammatory systemic conditions. Reduced muscle function is a cardinal symptom and lung involvement is very common. Knowledge of heart involvement in these patients is very limited, as is knowledge of exercise effects in recent onset, active disease. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Polymyositis, Dermatomyositis
- What is being tested?
- High-intensity interval training (HIIT) - myositis, Standard low-intensity home exercise and High-intensity interval training (HIIT) - healthy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Probable or definite diagnosis polymyositis or dermatomyositis according to Bohand and Peter criteria, diagnosis duration between 4 weeks and 6 months, completed screening for possible concurrent cancer diagnosis and screening for lung involvement, able to performe the HIIT.
Who cannot join
- Diagnosis of inclusion body myositis, active cancer, being treated for cancer, heart- or lung involvement contraindicating HIIT, no clinical improvement with medical treatment, severe osteoporosis.
- Healthy controls:
- Inclusion Criteria: match a patient for age and gender, exercising not more than twice a week, no neuro- or musculoskeletal disorders.
- Exclusion Criteria: Ongoing treatment for cancer, cardiovascular disease contraindicating a maximal oxygen uptake test or HIIT.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, N/A = Not Applicable, Se-171 76
Helene Alexanderson, PhD, Ass.prof, +46 8 51774596, helene.alexanderson@sll.se
Håkan Westerblad, Professor, +46 8 524 872 53, hakan.westerblad@ki.se
About this study
Official title: Effects of High-intensity Interval Training (HIIT) Compared to Low-intensity Exercise in Patients With Recent Onset Polymyositis and Dermatomyositis - a Randomized Controlled Trial
Polymyositis and dermatomyositis are rare inflammatory systemic conditions. Reduced muscle function is a cardinal symptom and lung involvement is very common. Knowledge of heart involvement in these patients is very limited, as is knowledge of exercise effects in recent onset, active disease.
The aim of this project is to investigate effects of high-intensity interval training (HIIT) compared to standard low-intensity home exercise as to tolerance, physical capacity, quality of life, depression, disease activity, inflammation, muscle mass/fat mass, muscle metabolism and heart function in patients with recent onset, active polymyositis and dermatomyositis.
Read more
This is a randomized controlled trial. Muscle biopsies are taken at time of diagnosis and after 12 weeks of exercise. Muscle biopsies will be analyzed as to baseline kynurenine pathway, calcium release, gene expression and inflammatory infiltrates and as to changes in these parameters following exercise. Muscle function (primary outcome), maximal oxygen uptake, muscle mass/fat mass, disease activity, systolic and diastolic heart function, as well as quality of life and depression is measured at baseline and after 12 weeks of exercise. After all assessments, patients are randomized to HIIT or standard low-intensity home exercise.
The HIIT group will perform 6 sets of 30-60 second biking bouts reaching 85-100% of maximal heart rate, in combination with strength training, three days a week for 12 weeks. The control group will perform a standardized home exercise program five days a week for 12 weeks. After 12 weeks, all assessments are preformed again. If the HIIT is well tolerated, patients in the control group will be invited to HIIT exercise according to the same protocol. Clinical assessments will be performed at 3, 6 and 9 months follow-up in an open extension.
This study will improve our understanding of heart function, muscle metabolism as well as tolerance and effects of intensive exercise as well as heart function early in the disease course and could also improve treatment and prognosis in patients with polymyositis and dermatomyositis.
Read the detailed description
Patients randomized to the HIIT protocol will train three days a week for 12 weeks. Before exercise start participants will rate self-reported pain and fatigue on a visual analogue scale and describe in own words information about possible changes in medication dose, any side effects from medication as well as possible negative and positive effects from previous exercise sessions, as well as physical activities performed since the previous exercise session. Each exercise session starts with a 5-minut warm-up on about 50% of maximal heart rate. Each HIIT set is between 30-60 seconds where loads are increased and the participant bikes as fast as possible with the goal of reaching >85% of maximal heart rate. During the 2-minuts rest in-between HIIT sets the participant will rate self-reported exertion using the Borg CR-10, 0-10 scale and the Borg RPE scale, 6-20.
When initiating the exercise period, participants start on three HIIT sets on a lower intensity, gradually increasing to goal intensity during the first two weeks. Then the number of sets are gradually increased to six sets.
After completing six HIIT sets the participants perform one set of 10 voluntary repetitions maximum (VRM) resistance training of the deltoids using free weights and of the quadriceps using free weights or a quadriceps curl machine, depending on degree of muscle weakness. Every other week a new 10 VRM is tested and training loads are adapted. After completing each set, the participant rates perceived muscle exertion on the Borg CR-10 scale. The program is ended with stretching of trained muscle groups and rating of overall exertion during the exercise session on the Borg RPE-scale.
Participants randomized to the control group will perform a standardized home exercise program on an easy-to moderate intensity adapted to initial muscle weakness, five days a week for 12 weeks. The program includes tasks for muscle groups targeted by myositis and takes about 15 minutes to perform. In combination with the home exercise program the participants walks 15 minutes on 60% of maximal heart rate. Participants fill out an exercise diary commenting on loads and number of repetitions for each task.
Participants in both groups ware a Polar 330A heart rate monitor during each training session. By synchronizing to a computer program all exercise data are stored in a cloud data base and can be monitored regularly by the project investigator.
- Conditions
- Polymyositis, Dermatomyositis
- Being tested
- High-intensity interval training (HIIT) - myositis, Standard low-intensity home exercise, High-intensity interval training (HIIT) - healthy
- Keywords
- High-intensity interval training, Exercise, Muscle function, Inflammation
- Medical subject headings
- Polymyositis, Dermatomyositis, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training (HIIT) - myositisOther
12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum.
Standard low-intensity home exerciseOther
12 weeks of 5 days/week low-intensity resistance home exercise in combination with outdoor walks of 20 minutes.
High-intensity interval training (HIIT) - healthyOther
12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training (HIIT) - myositis | Experimental | 12-week, 3d/w, HIIT Receives: Other: High-intensity interval training (HIIT) - myositis |
| Standard low-intensity home exercise control (CG) | Active comparator | 12-week, 5 d/w, home exercise. Receives: Other: Standard low-intensity home exercise |
| High-intensity interval training (HIIT) - healthy | Active comparator | 12-week, 3d/w, HIIT. Receives: Other: High-intensity interval training (HIIT) - healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max, L/min and ml/kgxmin
A maximal oxygen uptake test with ECG on a stationary bike. For patients with myositis, the test is started on 30W and increasing with 10W every minute until exhaustion. Ventilation and gas exchanges is assessed. Definition of max: ration CO2 / O2 = >1. The test is stopped when maximal effort according to above definition is reached or when the subjects cannot bike any longer due to exhaustion. Healthy subjects will start on 50W and then follow the same protocol. Subjects rate subjective exertion of thigh muscles, dyspnea on the Borg symptom scale, 0-10. After completion of test overall exertion is rated on the Borg RPE scale, 6-20.
Measured: 12 weeks
Secondary outcomes (25)
Aerobic capacity, Watt max
A maximal oxygen uptake test with ECG on a stationary bike. For patients with myositis, the test is started on 30W and increasing with 10W every minute until exhaustion. Ventilation and gas exchanges is assessed. Definition of max: ration CO2 / O2 = >1. The test is stopped when maximal effort according to above definition is reached or when the subjects cannot bike any longer due to exhaustion. Healthy subjects will start on 50W and then follow the same protocol. Subjects rate subjective exertion of thigh muscles, dyspnea on the Borg symptom scale, 0-10. After completion of test overall exertion is rated on the Borg RPE scale, 6-20.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - physician's global assessment.
A myositis-specific protocol in Biodex systems is used. After completing measures of MVIC, the subjects perform six sets of 12, 4-second contractions with a 6-second rest in-between. Set 1: 12 contractions on 20% of MVIC. For each set, intensity is increased by 10%. In the last, 6th set contractions are performed on 70% of MVIC. After each set, a new MVIC is tested. The MDAAT is a valid core set of measures to assess disease activity including physician's and patient's global assessment, measures of muscle strength, activity limitation and extra-muscular organ activity. Physician's global assessment is performed in a Visual Analogue Scale (VAS), 0-100.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - patient's global assessment
The MDAAT Patient's global assessment is performed in a Visual Analogue Scale (VAS), 0-100.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - Manual Muscle Test
The MDAAT Manual muscle test measures isometric muscle strength in 8 muscle groups with a composite score varying from 0-80, where 8 indicates good muscle strength.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - Health Assessment Questionnaire (HAQ).
The MDAAT, HAQ includes 20 questions about ability to perform daily activities with a composite score varying from 0-3, where 3 indicates severe limitations.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - serum creatine phosphokinase (CK).
The MDAAT, serum CK-levels is measured in mikrocat/L.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT constitutional
The MDAAT, MYOACT constitutional (fever, weight loss) is assessed on a VAS, 0-100.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT heart
The MDAAT, MYOACT heart involvement is assessed on a VAS, 0-100.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT lung
The MDAAT, MYOACT lung involvement is assessed on a VAS, 0-100.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT skeletal
The MDAAT, MYOACT skeletal (joint inflammation and bone density) involvement is assessed on a VAS, 0-100.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT gasto-intestinal tract.
The MDAAT, MYOACT gastro-intestinal tract involvement such as dysphagia is assessed on a VAS, 0-100.
Measured: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT skin
The MDAAT, MYOACT skin involvement (skin rash) is assessed on a VAS, 0-100.
Measured: 12 weeks
Myositis Damage Index (MDI) - muscle
Degree of skeletal muscle damage is assessed on a VAS, 0-100
Measured: 6 months
Myositis Damage Index (MDI) - lung
Degree of lung dagame is assessed on a VAS, 0-100
Measured: 6 months
Myositis Damage Index (MDI) gastro-intestinal tract
Degree of GI-tract damage is assessed on a VAS, 0-100.
Measured: 6 months
Myositis Damages Index (MDI) Skeletal
Degree of joint damage and osteoporosis is assessed on a VAS, 0-100.
Measured: 6 months
Myositis Damage Index (MDI) heart
Degree of damage of the heart is assessed on a VAS, 0-100.
Measured: 6 months
Stress echocardiography
Systolic and diastolic heart function is assessed by ultrasound of the heart.
Measured: 12 weeks
Inflammatory infiltrates in skeletal muscle
Muscle biopsies are analyzed for inflammatory infiltrates with immunohistochemistry.
Measured: 12 weeks
Gene expression
Muscle biopsies are analyzed with Micro Array technique
Measured: 12 weeks
ER-stress
Muscle biopies are analysed by ELIZA
Measured: 12 weeks
Proteins involved in kynurenine process
Muscle biopsies are analyzed by ELIZA
Measured: 12 weeks
Proteins involved in calcium release
Muscle biopsies are analyzed by ELIZA
Measured: 12 weeks
Isometric muscle strength
A myositis-specific protocol in Biodex systems is used. Following several familiarization sets, maximal voluntary isometric contraction (MVIC) is tested until three very similar contractions are recorded. The subjects rest one minute between each MVIC.
Measured: 12 weeks
Isomteric muscle fatigability
A myositis-specific protocol in Biodex systems is used. After completing measures of MVIC, the subjects perform six sets of 12, 4-second contractions with a 6-second rest in-between. Set 1: 12 contractions on 20% of MVIC. For each set, intensity is increased by 10%. In the last, 6th set contractions are performed on 70% of MVIC. After each set, a new MVIC is tested.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Oct 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PolymyositisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are dandomized to either a high-intensity interval group (HIIT) or a control group performing standard low-intensity home exercise.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Helene Alexanderson, Karolinska University Hospital
- Investigators
- Helene Alexanderson, PhD, Ass.Prof, Principal investigator, Karolinska University Hospital and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324152
- Sponsor's protocol ID
- KarolinskaUH1
- Acronym
- HIITmyositis
- Status last verified
- Apr 2018
- First submitted
- 5 Oct 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Muscle biopsies will be sent to Professor Kanneboyina Nagaraju, Professor and Founding Chair, Department of Pharmaceutical sciences, School of Pharmacy and Pharmaceutical Sciences AB-G34, Binghamton University, PO Box 6000 Binghamton, NY 13902-6000. Purpose: To analyse muscle biopsies for micro array analysis.
Publications
Cleary LC, Crofford LJ, Long D, Charnigo R, Clasey J, Beaman F, Jenkins KA, Fraser N, Srinivas A, Dhaon N, Hanaoka BY. Does computed tomography-based muscle density predict muscle function and health-related quality of life in patients with idiopathic inflammatory myopathies? Arthritis Care Res (Hoboken). 2015 Jul;67(7):1031-40. doi: 10.1002/acr.22557.
PubMed 25623494Alexanderson H. Physical exercise as a treatment for adult and juvenile myositis. J Intern Med. 2016 Jul;280(1):75-96. doi: 10.1111/joim.12481. Epub 2016 Feb 8.
PubMed 26854121Yamada T, Place N, Kosterina N, Ostberg T, Zhang SJ, Grundtman C, Erlandsson-Harris H, Lundberg IE, Glenmark B, Bruton JD, Westerblad H. Impaired myofibrillar function in the soleus muscle of mice with collagen-induced arthritis. Arthritis Rheum. 2009 Nov;60(11):3280-9. doi: 10.1002/art.24907.
PubMed 19877058Yamada T, Fedotovskaya O, Cheng AJ, Cornachione AS, Minozzo FC, Aulin C, Friden C, Turesson C, Andersson DC, Glenmark B, Lundberg IE, Rassier DE, Westerblad H, Lanner JT. Nitrosative modifications of the Ca2+ release complex and actin underlie arthritis-induced muscle weakness. Ann Rheum Dis. 2015 Oct;74(10):1907-14. doi: 10.1136/annrheumdis-2013-205007. Epub 2014 May 22.
PubMed 24854355Alexanderson H, Munters LA, Dastmalchi M, Loell I, Heimburger M, Opava CH, Lundberg IE. Resistive home exercise in patients with recent-onset polymyositis and dermatomyositis -- a randomized controlled single-blinded study with a 2-year followup. J Rheumatol. 2014 Jun;41(6):1124-32. doi: 10.3899/jrheum.131145. Epub 2014 May 1.
PubMed 24786930Munters LA, Loell I, Ossipova E, Raouf J, Dastmalchi M, Lindroos E, Chen YW, Esbjornsson M, Korotkova M, Alexanderson H, Nagaraju K, Crofford LJ, Jakobsson PJ, Lundberg IE. Endurance Exercise Improves Molecular Pathways of Aerobic Metabolism in Patients With Myositis. Arthritis Rheumatol. 2016 Jul;68(7):1738-50. doi: 10.1002/art.39624.
PubMed 26867141Alemo Munters L, Dastmalchi M, Andgren V, Emilson C, Bergegard J, Regardt M, Johansson A, Orefelt Tholander I, Hanna B, Liden M, Esbjornsson M, Alexanderson H. Improvement in health and possible reduction in disease activity using endurance exercise in patients with established polymyositis and dermatomyositis: a multicenter randomized controlled trial with a 1-year open extension followup. Arthritis Care Res (Hoboken). 2013 Dec;65(12):1959-68. doi: 10.1002/acr.22068.
PubMed 23861241Alemo Munters L, Dastmalchi M, Katz A, Esbjornsson M, Loell I, Hanna B, Liden M, Westerblad H, Lundberg IE, Alexanderson H. Improved exercise performance and increased aerobic capacity after endurance training of patients with stable polymyositis and dermatomyositis. Arthritis Res Ther. 2013 Aug 13;15(4):R83. doi: 10.1186/ar4263.
PubMed 23941324
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Interval Training (HIIT) Compared to Low-intensity Exercise in Patients With Recent Onset Polymyositis and Dermatomyositis - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03324152
- Acronym / sponsor ID
- HIITmyositis / KarolinskaUH1
- Conditions
- Polymyositis, Dermatomyositis
- Keywords
- High-intensity interval training, Exercise, Muscle function, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polymyositis and dermatomyositis are rare inflammatory systemic conditions. Reduced muscle function is a cardinal symptom and lung involvement is very common. Knowledge of heart involvement in these patients is very limited, as is knowledge of exercise effects in recent onset, active disease.
The aim of this project is to investigate effects of high-intensity interval training (HIIT) compared to standard low-intensity home exercise as to tolerance, physical capacity, quality of life, depression, disease activity, inflammation, muscle mass/fat mass, muscle metabolism and heart function in patients with recent onset, active polymyositis and dermatomyositis.
This is a randomized controlled trial. Muscle biopsies are taken at time of diagnosis and after 12 weeks of exercise. Muscle biopsies will be analyzed as to baseline kynurenine pathway, calcium release, gene expression and inflammatory infiltrates and as to changes in these parameters following exercise. Muscle function (primary outcome), maximal oxygen uptake, muscle mass/fat mass, disease activity, systolic and diastolic heart function, as well as quality of life and depression is measured at baseline and after 12 weeks of exercise. After all assessments, patients are randomized to HIIT or standard low-intensity home exercise.
The HIIT group will perform 6 sets of 30-60 second biking bouts reaching 85-100% of maximal heart rate, in combination with strength training, three days a week for 12 weeks. The control group will perform a standardized home exercise program five days a week for 12 weeks. After 12 weeks, all assessments are preformed again. If the HIIT is well tolerated, patients in the control group will be invited to HIIT exercise according to the same protocol. Clinical assessments will be performed at 3, 6 and 9 months follow-up in an open extension.
This study will improve our understanding of heart function, muscle metabolism as well as tolerance and effects of intensive exercise as well as heart function early in the disease course and could also improve treatment and prognosis in patients with polymyositis and dermatomyositis.
Detailed description
Patients randomized to the HIIT protocol will train three days a week for 12 weeks. Before exercise start participants will rate self-reported pain and fatigue on a visual analogue scale and describe in own words information about possible changes in medication dose, any side effects from medication as well as possible negative and positive effects from previous exercise sessions, as well as physical activities performed since the previous exercise session. Each exercise session starts with a 5-minut warm-up on about 50% of maximal heart rate. Each HIIT set is between 30-60 seconds where loads are increased and the participant bikes as fast as possible with the goal of reaching >85% of maximal heart rate. During the 2-minuts rest in-between HIIT sets the participant will rate self-reported exertion using the Borg CR-10, 0-10 scale and the Borg RPE scale, 6-20.
When initiating the exercise period, participants start on three HIIT sets on a lower intensity, gradually increasing to goal intensity during the first two weeks. Then the number of sets are gradually increased to six sets.
After completing six HIIT sets the participants perform one set of 10 voluntary repetitions maximum (VRM) resistance training of the deltoids using free weights and of the quadriceps using free weights or a quadriceps curl machine, depending on degree of muscle weakness. Every other week a new 10 VRM is tested and training loads are adapted. After completing each set, the participant rates perceived muscle exertion on the Borg CR-10 scale. The program is ended with stretching of trained muscle groups and rating of overall exertion during the exercise session on the Borg RPE-scale.
Participants randomized to the control group will perform a standardized home exercise program on an easy-to moderate intensity adapted to initial muscle weakness, five days a week for 12 weeks. The program includes tasks for muscle groups targeted by myositis and takes about 15 minutes to perform. In combination with the home exercise program the participants walks 15 minutes on 60% of maximal heart rate. Participants fill out an exercise diary commenting on loads and number of repetitions for each task.
Participants in both groups ware a Polar 330A heart rate monitor during each training session. By synchronizing to a computer program all exercise data are stored in a cloud data base and can be monitored regularly by the project investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients are dandomized to either a high-intensity interval group (HIIT) or a control group performing standard low-intensity home exercise.
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIIT) - myositis | Experimental | Other: High-intensity interval training (HIIT) - myositis12-week, 3d/w, HIIT |
| Standard low-intensity home exercise control (CG) | Active comparator | Other: Standard low-intensity home exercise12-week, 5 d/w, home exercise. |
| High-intensity interval training (HIIT) - healthy | Active comparator | Other: High-intensity interval training (HIIT) - healthy12-week, 3d/w, HIIT. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Probable or definite diagnosis polymyositis or dermatomyositis according to Bohand and Peter criteria, diagnosis duration between 4 weeks and 6 months, completed screening for possible concurrent cancer diagnosis and screening for lung involvement, able to performe the HIIT.
Key exclusion criteria (4 listed)
- Diagnosis of inclusion body myositis, active cancer, being treated for cancer, heart- or lung involvement contraindicating HIIT, no clinical improvement with medical treatment, severe osteoporosis.
- Inclusion Criteria: match a patient for age and gender, exercising not more than twice a week, no neuro- or musculoskeletal disorders.
- Exclusion Criteria: Ongoing treatment for cancer, cardiovascular disease contraindicating a maximal oxygen uptake test or HIIT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training (HIIT) - myositis12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum. | Other | High-intensity interval training (HIIT) - myositis |
| Standard low-intensity home exercise12 weeks of 5 days/week low-intensity resistance home exercise in combination with outdoor walks of 20 minutes. | Other | Standard low-intensity home exercise control (CG) |
| High-intensity interval training (HIIT) - healthy12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum. | Other | High-intensity interval training (HIIT) - healthy |
Primary outcome
VO2 max, L/min and ml/kgxmin
Time frame: 12 weeks
A maximal oxygen uptake test with ECG on a stationary bike. For patients with myositis, the test is started on 30W and increasing with 10W every minute until exhaustion. Ventilation and gas exchanges is assessed. Definition of max: ration CO2 / O2 = >1. The test is stopped when maximal effort according to above definition is reached or when the subjects cannot bike any longer due to exhaustion. Healthy subjects will start on 50W and then follow the same protocol. Subjects rate subjective exertion of thigh muscles, dyspnea on the Borg symptom scale, 0-10. After completion of test overall exertion is rated on the Borg RPE scale, 6-20.
25 secondary outcomes
Aerobic capacity, Watt max
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - physician's global assessment.
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - patient's global assessment
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - Manual Muscle Test
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - Health Assessment Questionnaire (HAQ).
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - serum creatine phosphokinase (CK).
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT constitutional
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT heart
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT lung
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT skeletal
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT gasto-intestinal tract.
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT skin
Time frame: 12 weeks
Myositis Damage Index (MDI) - muscle
Time frame: 6 months
Myositis Damage Index (MDI) - lung
Time frame: 6 months
Myositis Damage Index (MDI) gastro-intestinal tract
Time frame: 6 months
Myositis Damages Index (MDI) Skeletal
Time frame: 6 months
Myositis Damage Index (MDI) heart
Time frame: 6 months
Stress echocardiography
Time frame: 12 weeks
Inflammatory infiltrates in skeletal muscle
Time frame: 12 weeks
Gene expression
Time frame: 12 weeks
ER-stress
Time frame: 12 weeks
Proteins involved in kynurenine process
Time frame: 12 weeks
Proteins involved in calcium release
Time frame: 12 weeks
Isometric muscle strength
Time frame: 12 weeks
Isomteric muscle fatigability
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Background: PubMed 25623494Cleary LC, Crofford LJ, Long D, Charnigo R, Clasey J, Beaman F, Jenkins KA, Fraser N, Srinivas A, Dhaon N, Hanaoka BY. Does computed tomography-based muscle density predict muscle function and health-related quality of life in patients with idiopathic inflammatory myopathies? Arthritis Care Res (Hoboken). 2015 Jul;67(7):1031-40. doi: 10.1002/acr.22557.
- Background: PubMed 26854121Alexanderson H. Physical exercise as a treatment for adult and juvenile myositis. J Intern Med. 2016 Jul;280(1):75-96. doi: 10.1111/joim.12481. Epub 2016 Feb 8.
- Background: PubMed 19877058Yamada T, Place N, Kosterina N, Ostberg T, Zhang SJ, Grundtman C, Erlandsson-Harris H, Lundberg IE, Glenmark B, Bruton JD, Westerblad H. Impaired myofibrillar function in the soleus muscle of mice with collagen-induced arthritis. Arthritis Rheum. 2009 Nov;60(11):3280-9. doi: 10.1002/art.24907.
- Background: PubMed 24854355Yamada T, Fedotovskaya O, Cheng AJ, Cornachione AS, Minozzo FC, Aulin C, Friden C, Turesson C, Andersson DC, Glenmark B, Lundberg IE, Rassier DE, Westerblad H, Lanner JT. Nitrosative modifications of the Ca2+ release complex and actin underlie arthritis-induced muscle weakness. Ann Rheum Dis. 2015 Oct;74(10):1907-14. doi: 10.1136/annrheumdis-2013-205007. Epub 2014 May 22.
- Background: PubMed 24786930Alexanderson H, Munters LA, Dastmalchi M, Loell I, Heimburger M, Opava CH, Lundberg IE. Resistive home exercise in patients with recent-onset polymyositis and dermatomyositis -- a randomized controlled single-blinded study with a 2-year followup. J Rheumatol. 2014 Jun;41(6):1124-32. doi: 10.3899/jrheum.131145. Epub 2014 May 1.
- Background: PubMed 26867141Munters LA, Loell I, Ossipova E, Raouf J, Dastmalchi M, Lindroos E, Chen YW, Esbjornsson M, Korotkova M, Alexanderson H, Nagaraju K, Crofford LJ, Jakobsson PJ, Lundberg IE. Endurance Exercise Improves Molecular Pathways of Aerobic Metabolism in Patients With Myositis. Arthritis Rheumatol. 2016 Jul;68(7):1738-50. doi: 10.1002/art.39624.
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- Individual participant dataSharing planned: Yes. Muscle biopsies will be sent to Professor Kanneboyina Nagaraju, Professor and Founding Chair, Department of Pharmaceutical sciences, School of Pharmacy and Pharmaceutical Sciences AB-G34, Binghamton University, PO Box 6000 Binghamton, NY 13902-6000. Purpose: To analyse muscle biopsies for micro array analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene Alexanderson, PhD, Ass.Prof principal investigator
Karolinska University Hospital and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training (HIIT) - myositis, Standard low-intensity home exercise and High-intensity interval training (HIIT) - healthy in people with Polymyositis and Dermatomyositis, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helene Alexanderson, PhD, Ass.prof (+46 8 517745 96, helene.alexanderson@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max, L/min and ml/kgxmin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324152, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.