Condition category
Musculoskeletal Diseases
Date applied
16/06/2008
Date assigned
16/06/2008
Last edited
26/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.canios.ca/About_canios_studies_HIPP.aspx?AspxAutoDetectCookieSupport=1

Contact information

Type

Scientific

Primary contact

Dr Paul R. Fortin

ORCID ID

Contact details

UHN - TWH Research Institute
Toronto Western Hospital
MP10-304
399 Bathurst Street
Toronto
Ontario
M5T 2S8
Canada
+1 416 603 6265
pfortin@uhnresearch.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00188357

Protocol/serial number

MCT-82939

Study information

Scientific title

The Health Improvement and Prevention Program (HIPP) in systemic lupus erythematosus: a randomised, cross-over, open-label efficacy study

Acronym

HIPP

Study hypothesis

1. The Health Improvement and Prevention Program (HIPP) will improve the physical component (PCS) and mental component (MCS) summary scores of the 36-item short form (SF-36) health status survey by an average of 4 points
2. HIPP will reduce the Framingham 8-year projected risk of cardiovascular disease (CVD) in persons with systemic lupus erythematosus (SLE) by 20%
3. HIPP will improve the flow mediated dilatation (FMD) of brachial arteries significantly

Ethics approval

1. Research Ethics Board of the University Health Network, Toronto approved on the 13th January 2004 (ref: 03-0605-A)
2. Research Ethics Board of McGill University approved on the 1st December 2006 (ref: 03-034)
3. Research Ethics Board of the University of Western Ontario approved on the 31st January 2008 (ref: 13732)

Study design

Randomised, cross-over, open-label efficacy study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material can be found at http://www.canios.ca/About_canios_studies_HIPP.aspx?AspxAutoDetectCookieSupport=1

Condition

Systemic lupus erythematosus

Intervention

Experimental interventions:
1. Non-drug coronary artery risk reduction in the setting of lupus measured at three months for one year followed by every six months for one year
2. Non-drug osteoporosis risk reduction in the setting of lupus measured at three months for one year followed by every six months for one year
3. Non-drug exercise in the setting of lupus measured at three months for one year followed by every six months for one year
4. Non-drug mindfulness based stress reduction in the setting of lupus measured at three months for one year followed by every six months for one year

Control intervention:
Usual care for 12 months.

Added 26/02/2009:
Secondary sponsor details:
Toronto Western Hospital (Canada)
c/o Dr. Paul Fortin
University Health Network
399 Bathurst Street
MP-10-304
Toronto, Ontario, M5T-2S8
Canada
Tel: +1 416 603 5800 ext. 6267
Fax: +1 416 603 6288
Email: pfortin@uhnresearch.ca

Contact for public queries:
Dr Ellie Aghdassi, Ph.D.
University Health Network
Toronto Western Hospital
399 Bathurst Street
MP-10-301
Toronto, Ontario, M5T-2S8
Canada
Tel: +1 416 603 5800 ext. 2822
Fax: +1 416 603 6288
Email: ellie.aghdassi@uhn.on.ca

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

36-item short form health survey physical and mental component summary scale (SF-36 PCS and MCS) scores, coronary disease risk reduction profiles and flow-mediated dilatation of the brachial artery yearly for two years.

Secondary outcome measures

1. Bone health improvement: yearly while on prednisone; every two years for all others
2. Adherence to treatment: every three months for one year and every six months for one year

Overall trial start date

01/08/2003

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Systemic lupus erythematosus according to American College of Rheumatology (ACR) criteria
2. 18 years or older
3. Female
4. Able to read and English or French

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

310 patients to enroll (to achieve 260 completers)

Participant exclusion criteria

1. History of angina
2. Myocardial infarct
3. Cerebral vascular accident
4. Trans-ischaemic attack
5. Peripheral vascular disease
6. Osteoporosis with fracture confirmed by radiology
7. Pregnant or planning within two years
8. Cancer (if cancer-free for five years then eligible)

Recruitment start date

01/08/2003

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Canada

Trial participating centre

UHN - TWH Research Institute
Toronto, Ontario
M5T 2S8
Canada

Sponsor information

Organisation

University Health Network (Canada)

Sponsor details

200 Elizabeth Street
Toronto
Ontario
M5G 2C4
Canada

Sponsor type

University/education

Website

http://www.uhn.ca/index.htm

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82939)

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

Publication citations

Additional files

Editorial Notes