Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositis

NCT03324152 | Unknown

• 1 other identifier: KarolinskaUH1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Polymyositis; Dermatomyositis

Keywords

High-intensity interval training; Exercise; Muscle function; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (25)

• Aerobic capacity, Watt max

  12 weeks

• Myositis Disease Activity Assessment Tool (MDAAT) - physician's global assessment.

  12 weeks

• Myositis Disease Activity Assessment Tool (MDAAT) - patient's global assessment

  12 weeks

• Myositis Disease Activity Assessment Tool (MDAAT) - Manual Muscle Test

  12 weeks

• Myositis Disease Activity Assessment Tool (MDAAT) - Health Assessment Questionnaire (HAQ).

  12 weeks

Study Arms (3)

High-intensity interval training (HIIT) - myositis

EXPERIMENTAL

12-week, 3d/w, HIIT

Other: High-intensity interval training (HIIT) - myositis

Standard low-intensity home exercise control (CG)

ACTIVE COMPARATOR

12-week, 5 d/w, home exercise.

Other: Standard low-intensity home exercise

High-intensity interval training (HIIT) - healthy

ACTIVE COMPARATOR

12-week, 3d/w, HIIT.

Other: High-intensity interval training (HIIT) - healthy

Interventions

High-intensity interval training (HIIT) - myositis OTHER

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.

High-intensity interval training (HIIT) - myositis

Standard low-intensity home exercise OTHER

12 weeks of 5 days/week low-intensity resistance home exercise in combination with outdoor walks of 20 minutes.

Standard low-intensity home exercise control (CG)

High-intensity interval training (HIIT) - healthy OTHER

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.

High-intensity interval training (HIIT) - healthy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Healthy controls:

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, N/A = Not Applicable, Se-171 76, Sweden

RECRUITING

Related Publications (8)

• 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.

  PMID: 25623494 BACKGROUND

• Alexanderson 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.

  PMID: 26854121 BACKGROUND

• Yamada 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.

  PMID: 19877058 BACKGROUND

• Yamada 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.

  PMID: 24854355 BACKGROUND

• Alexanderson 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.

  PMID: 24786930 BACKGROUND

• Munters 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.

  PMID: 26867141 BACKGROUND

• Alemo 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.

  PMID: 23861241 BACKGROUND

• Alemo 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.

  PMID: 23941324 BACKGROUND

MeSH Terms

Conditions

Polymyositis; Dermatomyositis; Motor Activity; Inflammation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helene Alexanderson, PhD, Ass.Prof

  Karolinska University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene Alexanderson, PhD, Ass.prof

CONTACT

+46 8 517745 96; helene.alexanderson@sll.se

Håkan Westerblad, Professor

CONTACT

+46 8 524 872 53; hakan.westerblad@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The physical therapist performing assessments of muscle function (primary outcome), distributes questionnaires and who is present at maximal oxygen uptake tests and who plan all other assessments logistically is blinded to group allocation. The rheumatologists performing assessment of disease activity and the personell analysing biopsy data are also blinded to group allocation. The care provider is the only one who is not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, RPT

Model Details: Patients are dandomized to either a high-intensity interval group (HIIT) or a control group performing standard low-intensity home exercise.

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 27, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: April 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: After completion of the project, muscle biopsies from all patients and healthy subjects will be sent to Dr Nagaraju.

Locations

SE (1)