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CompletedNCT00213187Updated Dec 18, 2013

PEAK Study (Physical Exercise and Activity in Kids)

A Phase 2 interventional study of Aerobic and Qi gong Exercise in Juvenile Idiopathic Arthritis, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2013-12-18.

Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
8 Years to 16 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
80 participants

Interventions

  • BehavioralAerobic and Qi gong Exercise
06

What researchers measure

Primary outcomes

  1. walking economy at completion of the exercise program

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

Secondary outcomes

  1. Peak aerobic capacity (VO2 peak) measured post-exercise program

  2. Anaerobic Power as measured by a Modified Wingate test at completion of the exercise program

  3. Anthropometry as measured by Body Mass Index (BMI) and skinfold at completion of the exercise program

  4. Improved physical function measured post treatment

  5. Improved daily activity measured post treatment

  6. Improved quality of life measure post treatment

  7. Decreased arthritis activity measured post treatment

  8. Improved range of motion measure post treatment

07

Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

References and documents

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. PubMed 18050186 ↗
  • 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. PubMed 17907238 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00213187
Lead sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Brian Feldman (Division Head, Rheumatology, The Hospital for Sick Children) — Principal investigator
First posted
Sep 21, 2005
Start date
Aug 2002
Completion
Nov 2005
Last update
Dec 18, 2013

Study contacts

Brian M. Feldman, MD
principal investigator · The Hospital for Sick Children
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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