The effects of vigorous exercise training on motor function and functional fitness in juvenile arthritis

ISRCTN	ISRCTN12040055
DOI	https://doi.org/10.1186/ISRCTN12040055
ClinicalTrials.gov (NCT)	NCT00213187
Protocol serial number	MCT-75507
Sponsor	The Hospital for Sick Children (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-75507), The Arthritis Society (Canada)

Submission date: 14/03/2007
Registration date: 14/03/2007
Last edited: 19/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian Michael Feldman
Scientific

The Hospital for Sick Children
Division of Rheumatology, Room 8248
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada

Phone	+1 416 813 5828
Email	brian.feldman@sickkids.ca

Study information

Primary study design	Interventional
Study design	Two-arm single centre randomised parallel trial with outcome assessor blinding
Secondary study design	Randomised controlled trial
Scientific title	The effects of vigorous exercise training on motor function and functional fitness in juvenile arthritis: a single blind randomised controlled trial
Study acronym	PEAK
Study objectives	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(s)	Research Ethics Board of the Hospital for Sick Children (Canada) approved on the 13th August 2002 (initially), 11th August 2006 (second) (ref: 0020020201).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Improved metabolic walking efficiency (measured by oxygen consumption) at baseline (week zero) and completion of trial (week 12)
Key secondary outcome measure(s)	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
Completion date	01/09/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/03/2003
Date of final enrolment	01/09/2005

Locations

Countries of recruitment

Canada

Study participating centre

The Hospital for Sick Children

Ontario
M5G 1X8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/10/2007		Yes	No