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

This study is currently recruiting participants.
Verified June 2011 by Karolinska Institutet
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: professor Ingrid Lundberg, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01184625     History of Changes
Other Study ID Numbers: Exercise
Study First Received: August 17, 2010
Last Updated: June 24, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013