Skip to main content
Clinical Trials/NCT00213187
NCT00213187
Completed
Phase 2

The Effect of Vigorous Exercise on Motor Function and Functional Fitness in Juvenile Arthritis

The Hospital for Sick Children1 site in 1 country80 target enrollmentAugust 2002

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Juvenile Idiopathic Arthritis
Sponsor
The Hospital for Sick Children
Enrollment
80
Locations
1
Primary Endpoint
walking economy at completion of the exercise program
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The objectives of this study are to study the effect of formal exercise training on motor function and overall physical fitness in children with arthritis. A 12-week comprehensive exercise program will be used. Formal exercise training will be compared to Qi gong.

Detailed Description

Childhood arthritis is a common and often debilitating disease. Children with arthritis are less active than their peers, and consequently they often have poor physical fitness. This study follows up our pilot study, in which we showed that exercise training can be safely carried out in children who have arthritis. We plan to randomly assign 80 children with arthritis to one of two groups. The experimental group undergoes a vigorous exercise training program consisting of twelve weekly supervised sessions as well as twice weekly at home sessions using an exercise video. The control group also has twelve supervised sessions and two home sessions. However, their exercises are non-strenuous, based on Qi gong. All children have comprehensive fitness testing before and after the training at the exercise lab at the Hospital for Sick Children. If we show that fitness exercise leads to improved motor function and improved ability to carry out activities of daily living, then we will change the way in which we provide therapy for childhood arthritis. We hope that this study will lead to an improved quality of life for children with arthritis.

Registry
clinicaltrials.gov
Start Date
August 2002
End Date
November 2005
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian Feldman

Division Head, Rheumatology

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

  • Age 8 - 16 years.
  • Diagnosis of Juvenile Idiopathic Arthritis - based on the revised Durban criteria.
  • Polyarticular or pauciarticular course.
  • Stable Disease - on a stable dose of NSAID, and if applicable methotrexate or other second line agents - in the preceding month, and judged by the attending rheumatologist to be clinically stable and unlikely to need a change in medication over the course of the trial.
  • Medications. There are no restrictions on medication use for this study; however, every effort is made to keep medication dosage stable over the course of study.

Exclusion Criteria

  • Co-morbidity with cardiac, pulmonary or metabolic disease.
  • Moderate or severe hip pain while walking (as judged by the patient and scored on a 4 point scale) or active systemic symptoms (fever, rash).
  • Children who engage in more than 3 hours of structured extracurricular physical activity weekly may not show additional gains from fitness training and, therefore, are not studied. Children are not otherwise excluded from the study if currently attending a physiotherapy pool program with emphasis on joint range of motion and stretching.
  • Children who are unable to cooperate with testing procedures.

Outcomes

Primary Outcomes

walking economy at completion of the exercise program

PEAK power, muscular endurance, and subjective function at completion of the exercise program

Secondary Outcomes

  • Improved daily activity measured post treatment
  • Improved quality of life measure post treatment
  • Decreased arthritis activity measured post treatment
  • Improved range of motion measure post treatment
  • Peak aerobic capacity (VO2 peak) measured post-exercise program
  • Anaerobic Power as measured by a Modified Wingate test at completion of the exercise program
  • Anthropometry as measured by Body Mass Index (BMI) and skinfold at completion of the exercise program
  • Improved physical function measured post treatment

Study Sites (1)

Loading locations...

Similar Trials