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 number NCT00213187
Secondary identifying numbers MCT-75507
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

Study designTwo-arm single centre randomised parallel trial with outcome assessor blinding
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effects of vigorous exercise training on motor function and functional fitness in juvenile arthritis: a single blind randomised controlled trial
Study acronymPEAK
Study objectivesA 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) studiedJuvenile idiopathic arthritis
InterventionTreatment 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 typeOther
Primary outcome measureImproved metabolic walking efficiency (measured by oxygen consumption) at baseline (week zero) and completion of trial (week 12)
Secondary outcome measures1. 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 study start date01/03/2003
Completion date01/09/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit16 Years
SexBoth
Target number of participants80
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2003
Date of final enrolment01/09/2005

Locations

Countries of recruitment

  • Canada

Study participating centre

The Hospital for Sick Children
Ontario
M5G 1X8
Canada

Sponsor information

The Hospital for Sick Children (Canada)
Hospital/treatment centre

c/o Dr Janet Rossant
Chief of Research
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada

Phone +1 416 813 6577
Email janet.rossant@sickkids.ca
Website http://www.sickkids.ca/
ROR logo "ROR" https://ror.org/057q4rt57

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca/ (ref: MCT-75507)

No information available

The Arthritis Society (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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