NCT00519103

Brief Summary

The aim of this study was to investigate the effects of physical exercise on gene expression in muscle biopsies from patients with chronic polymyositis or dermatomyositis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2002

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
Last Updated

August 30, 2007

Status Verified

August 1, 2007

First QC Date

August 20, 2007

Last Update Submit

August 29, 2007

Conditions

MyositisExercise

Keywords

microarrayInflammtionfibrosis

Outcome Measures

Primary Outcomes (1)

  • effects of physical exercise muscle strength and function in patients with chronic polymyositis or dermatomyositis

    7weeks

Secondary Outcomes (1)

  • effects of exercise on gene expression and corresponding protein expression in muscle tissue and on signs of inflammation in peripheral blood

    7 weeks

Study Arms (1)

1

EXPERIMENTAL

Active resistive excercise for 7 weeks

Other: exercise

Interventions

exerciseOTHER
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients were included if they had a disease duration more than 12 months and they had to have a stable, low disease activity and medication for three months before enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology unit, Karolinska Unirversity hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

MyositisMotor ActivityFibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ingrid E Lundberg, MD, PhD

    Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 21, 2007

Study Start

December 1, 2002

Study Completion

March 1, 2003

Last Updated

August 30, 2007

Record last verified: 2007-08

Locations

SE(1)