Contact information
Type
Scientific
Primary contact
Dr Brian Michael Feldman
ORCID ID
Contact details
The Hospital for Sick Children
Division of Rheumatology
Room 8248
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
+1 416 813 5828
brian.feldman@sickkids.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00213187
Protocol/serial number
MCT-75507
Study information
Scientific title
The effects of vigorous exercise training on motor function and functional fitness in juvenile arthritis: a single blind randomised controlled trial
Acronym
PEAK
Study hypothesis
A rigorous 12-week aerobic exercise training program is more effective in improving metabolic efficiency (in terms of oxygen cost of locomotion) than a gentle Qigong exercise program.
Ethics approval
Research Ethics Board of the Hospital for Sick Children (Canada) approved on the 13th August 2002 (initially), 11th August 2006 (second) (ref: 0020020201).
Study design
Two-arm single centre randomised parallel trial with outcome assessor blinding
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Juvenile idiopathic arthritis
Intervention
Treatment group: a 12-week vigorous aerobic exercise program
Control group: a 12-week Qi gong exercise program
Contact for public queries:
Samantha Stephens
Clinical Research Project Manager
The Hospital for Sick Children
555 University Avenue
Canada
M5G 1X8
Tel: +1 416 813 7678
Fax: +1 416 813-7337
E-mail: samantha.stephens@sickkids.ca
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Improved metabolic walking efficiency (measured by oxygen consumption) at baseline (week zero) and completion of trial (week 12)
Secondary outcome measures
1. Maximal aerobic capacity at week zero and 12
2. Anaerobic endurance and peak muscle power at week zero and 12
3. Physical function at week zero and 12
4. Quality of life at week zero and 12
5. Safety testing at week zero and 12
6. Arthritis activity (pain) from week zero through to 12
7. Range of motion at week zero and 12
8. Heart rate monitoring from week zero through to 12
9. Ratings of Perceived Exertion (RPE) from week zero through to 12
10. Anthropometry at week zero and 12
11.Comfortable walking speed at week zero and 12
12. Acceptability of exercise training (qualitative questionnaire) upon completion of program at week 12
Overall trial start date
01/03/2003
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged eight to 16 years, either sex
2. Diagnosis of juvenile idiopathic arthritis
3. Stable disease - on a stable dose of non-steroidal anti-inflammatory drugs (NSAID), if applicable methotrexate or other second line agents - in the preceding month, and judged by the rheumatologist to be clinically stable over the course of the trial
4. Medications: there are no restrictions on medication use for this study, however, every effort is made to keep medication dose stable over the course of the study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
80
Participant 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 four point scale)
3. Active systemic symptoms (fever or rash)
4. Children who engaged in three or more hours of extracurricular physical activity weekly
5. Children who are unable to cooperate with testing procedures
Recruitment start date
01/03/2003
Recruitment end date
01/09/2005
Locations
Countries of recruitment
Canada
Trial participating centre
The Hospital for Sick Children
Ontario
M5G 1X8
Canada
Sponsor information
Organisation
The Hospital for Sick Children (Canada)
Sponsor details
c/o Dr Janet Rossant
Chief of Research
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
+1 416 813 6577
janet.rossant@sickkids.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-75507)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Arthritis Society (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17907238
Publication citations
-
Results
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, 57, 7, 1202-1210, doi: 10.1002/art.23008.