Back to resultsPEAK Study (Physical Exercise and Activity in Kids)
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Aerobic and Qi gong Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring Juvenile Rheumatoid Arthritis,, Randomized Control Trial,, attention placebo,, exercise testing,, aerobics,, Qi Gong,, exercise video,, activities of daily living,, quality of life,, economy of walking,, fitness, pediatrics
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.
Sites / Locations
- The Hospital for Sick Children
Outcomes
Primary Outcome Measures
walking economy at completion of the exercise program
PEAK power, muscular endurance, and subjective function at completion of the exercise program
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT00213187
First Posted
September 13, 2005
Last Updated
December 17, 2013
Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00213187
Brief Title
PEAK Study (Physical Exercise and Activity in Kids)
Official Title
The Effect of Vigorous Exercise on Motor Function and Functional Fitness in Juvenile Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
Juvenile Rheumatoid Arthritis,, Randomized Control Trial,, attention placebo,, exercise testing,, aerobics,, Qi Gong,, exercise video,, activities of daily living,, quality of life,, economy of walking,, fitness, pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Aerobic and Qi gong Exercise
Primary Outcome Measure Information:
Title
walking economy at completion of the exercise program
Title
PEAK power, muscular endurance, and subjective function at completion of the exercise program
Secondary Outcome Measure Information:
Title
Peak aerobic capacity (VO2 peak) measured post-exercise program
Title
Anaerobic Power as measured by a Modified Wingate test at completion of the exercise program
Title
Anthropometry as measured by Body Mass Index (BMI) and skinfold at completion of the exercise program
Title
Improved physical function measured post treatment
Title
Improved daily activity measured post treatment
Title
Improved quality of life measure post treatment
Title
Decreased arthritis activity measured post treatment
Title
Improved range of motion measure post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M. Feldman, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18050186
Citation
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.
Results Reference
derived
PubMed Identifier
17907238
Citation
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.
Results Reference
derived
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PEAK Study (Physical Exercise and Activity in Kids)
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