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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Karolinska Institutet.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184625
First Posted: August 19, 2010
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Uppsala University Hospital
Sahlgrenska University Hospital, Sweden
Information provided by:
Karolinska Institutet
  Purpose
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 Intervention
Myositis Other: Physical Exercise

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

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

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

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Other: Physical Exercise
12 weeks of physical exercise.
No Intervention: No intervention
12 weeks of stable physical exercise level.

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

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 Submitted: August 17, 2010
First Posted: August 19, 2010
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