Condition category
Musculoskeletal Diseases
Date applied
14/03/2007
Date assigned
14/03/2007
Last edited
19/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sickkids.ca/

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

  1. 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.

Additional files

Editorial Notes