PEAK Study (Physical Exercise and Activity in Kids)
The Effect of Vigorous Exercise on Motor Function and Functional Fitness in Juvenile Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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walking economy at completion of the exercise program
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PEAK power, muscular endurance, and subjective function at completion of the exercise program
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Secondary Outcome Measures
Outcome Measure |
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Peak aerobic capacity (VO2 peak) measured post-exercise program
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Anaerobic Power as measured by a Modified Wingate test at completion of the exercise program
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Anthropometry as measured by Body Mass Index (BMI) and skinfold at completion of the exercise program
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Improved physical function measured post treatment
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Improved daily activity measured post treatment
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Improved quality of life measure post treatment
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Decreased arthritis activity measured post treatment
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Improved range of motion measure post treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian M. Feldman, MD, The Hospital for Sick Children
Publications and helpful links
General Publications
- Stephens S, Singh-Grewal D, Bar-Or O, Beyene J, Cameron B, Leblanc CM, Schneider R, Schneiderman-Walker J, Selvadurai H, Silverman E, Spiegel L, Tse SM, Wright V, Feldman BM. Reliability of exercise testing and functional activity questionnaires in children with juvenile arthritis. Arthritis Rheum. 2007 Dec 15;57(8):1446-52. doi: 10.1002/art.23089.
- Singh-Grewal D, Schneiderman-Walker J, Wright V, Bar-Or O, Beyene J, Selvadurai H, Cameron B, Laxer RM, Schneider R, Silverman ED, Spiegel L, Tse S, Leblanc C, Wong J, Stephens S, Feldman BM. The effects of vigorous exercise training on physical function in children with arthritis: a randomized, controlled, single-blinded trial. Arthritis Rheum. 2007 Oct 15;57(7):1202-10. doi: 10.1002/art.23008.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0020020201
- 137845 (CIHR)
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