Clinical trial NCT01184625: Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation
Official title: Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myositis
Keywords: Myositis
Physical exercise
Disability
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: Sahlgrenska University Hospital
First posted: 2010-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to test if hypoxia in muscle tissue is an important factor contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in patients with chronic rheumatic muscle inflammation.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic, stable polymyositis or dermatomyositis with diagnosis of definite or probable polymyositis or dermatomyositis (Bohan and Peter 1975)
* Age 18-80 years
* Duration since diagnosis \> 6 months
* Exercising \< once a week,
* Stable disease activity and medication for at least one month.

Ten healthy controls matched for age, gender and physical exercise level will be included.

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Exclusion Criteria:

* Severe pulmonary fibrosis
* Heart or lung conditions that contraindicate vigorous exercise
* Severe osteoporosis
* Not being able to perform the exercise program.

Primary outcomes:
measure: Hypoxia related metabolites.
timeFrame: At baseline before intervention.
measure: Hypoxia related metabolites.
timeFrame: After 12 weeks of endurance exercise intervention/ non intervention.
Secondary outcomes:
measure: Muscle impairment.
timeFrame: At baseline before intervention.
measure: Muscle impairment.
timeFrame: After 12 weeks of endurance exercise intervention/ non intervention.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Rheumatology unit, Karolinska University Hospital
Study officials:
affiliation: Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet
name: Ingrid E Lundberg, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boehler JF, Hogarth MW, Barberio MD, Novak JS, Ghimbovschi S, Brown KJ, Alemo Munters L, Loell I, Chen YW, Gordish-Dressman H, Alexanderson H, Lundberg IE, Nagaraju K. Effect of endurance exercise on microRNAs in myositis skeletal muscle-A randomized controlled study. PLoS One. 2017 Aug 22;12(8):e0183292. doi: 10.1371/journal.pone.0183292. eCollection 2017.
citation: 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.
citation: 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.