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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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):

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.

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.

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.

• Responsible Party: professor Ingrid Lundberg, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT01184625
• Other Study ID Numbers: Exercise
• 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:

Myositis; Inflammation; Pathologic Processes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases