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

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ClinicalTrials.gov Identifier: NCT01184625
Recruitment Status : Unknown
Verified June 2011 by Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : August 19, 2010
Last Update Posted : June 27, 2011
Sponsor:
Collaborators:
Uppsala University Hospital
Sahlgrenska University Hospital, Sweden
Information provided by:
Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Myositis Other: Physical Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation
Study Start Date : January 2008
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : August 2012


Arm Intervention/treatment
Experimental: Exercise Other: Physical Exercise
12 weeks of physical exercise.
No Intervention: No intervention
12 weeks of stable physical exercise level.



Primary Outcome Measures :
  1. Hypoxia related metabolites. [ Time Frame: At baseline before intervention. ]
  2. Hypoxia related metabolites. [ Time Frame: After 12 weeks of endurance exercise intervention/ non intervention. ]

Secondary Outcome Measures :
  1. Muscle impairment. [ Time Frame: At baseline before intervention. ]
  2. Muscle impairment. [ Time Frame: After 12 weeks of endurance exercise intervention/ non intervention. ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184625


Contacts
Contact: Ingrid E Lundberg, MD, PhD, Prof +46 8 517700 ext 6087 ingrid.lundberg@ki.se

Locations
Sweden
Rheumatology unit, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Ingrid E Lundberg, MD, PhD, Prof    +46 8 517700 ext 6087    ingrid.lundberg@ki.se   
Sponsors and Collaborators
Karolinska Institutet
Uppsala University Hospital
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Ingrid E Lundberg, MD, PhD, Prof Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: professor Ingrid Lundberg, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01184625     History of Changes
Other Study ID Numbers: Exercise
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Karolinska Institutet:
Myositis
Physical exercise
Disability

Additional relevant MeSH terms:
Inflammation
Myositis
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases