Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation

NCT ID: NCT01184625

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

Group Type EXPERIMENTAL

Physical Exercise

Intervention Type OTHER

12 weeks of physical exercise.

No intervention

12 weeks of stable physical exercise level.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical Exercise

12 weeks of physical exercise.

Intervention Type OTHER

Eligibility Criteria

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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.

\-

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Karolinska Institutet

Principal Investigators

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Ingrid E Lundberg, MD, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet

Locations

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Rheumatology unit, Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Ingrid E Lundberg, MD, PhD, Prof

Role: CONTACT

+46 8 517700 ext. 6087

Facility Contacts

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Ingrid E Lundberg, MD, PhD, Prof

Role: primary

+46 8 517700 ext. 6087

References

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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.

Reference Type DERIVED
PMID: 28829792 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23941324 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23861241 (View on PubMed)

Other Identifiers

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Exercise

Identifier Type: -

Identifier Source: org_study_id

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