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

Primary Purpose

Myositis

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical Exercise
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myositis focused on measuring Myositis, Physical exercise, Disability

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rheumatology unit, Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

No intervention

Arm Description

12 weeks of stable physical exercise level.

Outcomes

Primary Outcome Measures

Hypoxia related metabolites.
Hypoxia related metabolites.

Secondary Outcome Measures

Muscle impairment.
Muscle impairment.

Full Information

First Posted
August 17, 2010
Last Updated
June 24, 2011
Sponsor
Karolinska Institutet
Collaborators
Uppsala University Hospital, Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01184625
Brief Title
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation
Official Title
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet
Collaborators
Uppsala University Hospital, Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myositis
Keywords
Myositis, Physical exercise, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
12 weeks of stable physical exercise level.
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
12 weeks of physical exercise.
Primary Outcome Measure Information:
Title
Hypoxia related metabolites.
Time Frame
At baseline before intervention.
Title
Hypoxia related metabolites.
Time Frame
After 12 weeks of endurance exercise intervention/ non intervention.
Secondary Outcome Measure Information:
Title
Muscle impairment.
Time Frame
At baseline before intervention.
Title
Muscle impairment.
Time Frame
After 12 weeks of endurance exercise intervention/ non intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid E Lundberg, MD, PhD, Prof
Phone
+46 8 517700
Ext
6087
Email
ingrid.lundberg@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid E Lundberg, MD, PhD, Prof
Organizational Affiliation
Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology unit, Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid E Lundberg, MD, PhD, Prof
Phone
+46 8 517700
Ext
6087
Email
ingrid.lundberg@ki.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
28829792
Citation
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.
Results Reference
derived
PubMed Identifier
23941324
Citation
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.
Results Reference
derived
PubMed Identifier
23861241
Citation
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.
Results Reference
derived

Learn more about this trial

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

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