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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 because the information has not been verified recently.
Verified June 2011 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Uppsala University Hospital
Sahlgrenska University Hospital, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01184625
First received: August 17, 2010
Last updated: June 24, 2011
Last verified: June 2011

August 17, 2010
June 24, 2011
January 2008
January 2012   (final data collection date for primary outcome measure)
  • Hypoxia related metabolites. [ Time Frame: At baseline before intervention. ] [ Designated as safety issue: No ]
  • Hypoxia related metabolites. [ Time Frame: After 12 weeks of endurance exercise intervention/ non intervention. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01184625 on ClinicalTrials.gov Archive Site
  • Muscle impairment. [ Time Frame: At baseline before intervention. ] [ Designated as safety issue: No ]
  • Muscle impairment. [ Time Frame: After 12 weeks of endurance exercise intervention/ non intervention. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Myositis
Other: Physical Exercise
12 weeks of physical exercise.
  • Experimental: Exercise
    Intervention: Other: Physical Exercise
  • No Intervention: No intervention
    12 weeks of stable physical exercise level.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact: Ingrid E Lundberg, MD, PhD, Prof +46 8 517700 ext 6087 ingrid.lundberg@ki.se
Sweden
 
NCT01184625
Exercise
No
professor Ingrid Lundberg, Karolinska Institutet
Karolinska Institutet
  • Uppsala University Hospital
  • Sahlgrenska University Hospital, Sweden
Principal Investigator: Ingrid E Lundberg, MD, PhD, Prof Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet
Karolinska Institutet
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP