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
  Purpose

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.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Behavioral: Aerobic and Qi gong Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effect of Vigorous Exercise on Motor Function and Functional Fitness in Juvenile Arthritis

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

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

Estimated Enrollment: 80
Study Start Date: August 2002
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213187

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Brian M. Feldman, MD The Hospital for Sick Children
  More Information

No publications provided by The Hospital for Sick Children

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Feldman, Division Head, Rheumatology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00213187     History of Changes
Other Study ID Numbers: 0020020201, 137845 (CIHR)
Study First Received: September 13, 2005
Last Updated: December 17, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by The Hospital for Sick Children:
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

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014