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

Myositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01184625
• Other study ID #: Exercise
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2010
• Last updated: June 24, 2011
• Start date: January 2008
• Est. completion date: August 2012

Study information

• Verified date: June 2011
• Source: Karolinska Institutet
• Contact: Ingrid E Lundberg, MD, PhD, Prof
• Phone: +46 8 517700
• Email: ingrid.lundberg[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myositis

Intervention

Other:
• Physical Exercise
12 weeks of physical exercise.

Locations

Country	Name	City	State
Sweden	Rheumatology unit, Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Sahlgrenska University Hospital, Sweden, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxia related metabolites.		At baseline before intervention.	No
Primary	Hypoxia related metabolites.		After 12 weeks of endurance exercise intervention/ non intervention.	No
Secondary	Muscle impairment.		At baseline before intervention.	No
Secondary	Muscle impairment.		After 12 weeks of endurance exercise intervention/ non intervention.	No