NCT01184625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

August 17, 2010

Last Update Submit

June 24, 2011

Conditions

Myositis

Keywords

MyositisPhysical exerciseDisability

Outcome Measures

Primary Outcomes (2)

  • Hypoxia related metabolites.

    At baseline before intervention.

  • Hypoxia related metabolites.

    After 12 weeks of endurance exercise intervention/ non intervention.

Secondary Outcomes (2)

  • Muscle impairment.

    At baseline before intervention.

  • Muscle impairment.

    After 12 weeks of endurance exercise intervention/ non intervention.

Study Arms (2)

Exercise

EXPERIMENTAL
Other: Physical Exercise

No intervention

NO INTERVENTION

12 weeks of stable physical exercise level.

Interventions

Physical ExerciseOTHER

12 weeks of physical exercise.

Exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology unit, Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28829792DERIVED

  • 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: 23941324DERIVED

  • 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: 23861241DERIVED

MeSH Terms

Conditions

MyositisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ingrid E Lundberg, MD, PhD, Prof

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid E Lundberg, MD, PhD, Prof

CONTACT

+46 8 517700ingrid.lundberg@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

August 1, 2012

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

SE(1)