PEAK Study (Physical Exercise and Activity in Kids)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213187
First received: September 13, 2005
Last updated: December 17, 2013
Last verified: December 2013

September 13, 2005
December 17, 2013
August 2002
Not Provided
  • walking economy at completion of the exercise program
  • PEAK power, muscular endurance, and subjective function at completion of the exercise program
  • - walking economy at completion of the exercise program
  • - PEAK power, muscular endurance, and subjective function at completion of the exercise program
Complete list of historical versions of study NCT00213187 on ClinicalTrials.gov Archive Site
  • 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
  • - 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
Not Provided
Not Provided
 
PEAK Study (Physical Exercise and Activity in Kids)
The Effect of Vigorous Exercise on Motor Function and Functional Fitness in Juvenile Arthritis

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Juvenile Idiopathic Arthritis
Behavioral: Aerobic and Qi gong Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2005
Not Provided

Inclusion Criteria:

  1. Age 8 - 16 years.
  2. Diagnosis of Juvenile Idiopathic Arthritis - based on the revised Durban criteria.
  3. Polyarticular or pauciarticular course.
  4. 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.
  5. 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:

  1. Co-morbidity with cardiac, pulmonary or metabolic disease.
  2. 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).
  3. 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.
  4. Children who are unable to cooperate with testing procedures.
Both
8 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00213187
0020020201, 137845 (CIHR)
Not Provided
Brian Feldman, The Hospital for Sick Children
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Brian M. Feldman, MD The Hospital for Sick Children
The Hospital for Sick Children
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP