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
Scientific
The Hospital for Sick Children
Division of Rheumatology, Room 8248
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
| Phone | +1 416 813 5828 |
|---|---|
| brian.feldman@sickkids.ca |
Study information
| Study design | Two-arm single centre randomised parallel trial with outcome assessor blinding |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/03/2003 |
| Completion date | 01/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 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
M5G 1X8
Canada
Sponsor information
The Hospital for Sick Children (Canada)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Janet Rossant
Chief of Research
555 University Avenue
Toronto
Ontario
M5G 1X8
Canada
| Phone | +1 416 813 6577 |
|---|---|
| janet.rossant@sickkids.ca | |
| Website | http://www.sickkids.ca/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
