Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/01/2010
Date assigned
21/06/2010
Last edited
21/06/2010
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 Paul Oh

ORCID ID

Contact details

Toronto Rehabilitation Institute
347 Rumsey Rd
Toronto
M4G 1R7
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

#19581

Study information

Scientific title

Finding the optimal volume and intensity of resistance training exercise for type 2 diabetes: a randomised controlled trial

Acronym

The FORTE Study

Study hypothesis

A higher intensity, hypertrophic resistance training protocol added to aerobic training would lead to more marked improvements to glycaemic control and cardiovascular risk factors compared to lower intensity endurance training.

Ethics approval

University of Toronto Research Ethics Board (REB) approved in February 2006 (ref: 19581)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Six months of aerobic and resistance training:
1. Aerobic training and minimal resistance training (usual care)
2. Aerobic training and high intensity resistance training
3. Aerobic training and low intensity resistance training

The intervention for all groups was 6 months. Following completion of the program, patients will not be followed-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured at baseline and 6 months:
1. HbA1c
2. Maximal aerobic power (VO2 max)

Secondary outcome measures

Measured at baseline and 6 months:
1. Fasting glucose
2. Insulin
3. Proinsulin
4. Blood lipid profile
5. Body composition (dual energy x-ray absorptiometry [DEXA])
6. Cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], c-reactive protein [CRP])
7. Adipokines (tumour necrotising factor-alpha [TNF-alpha], adiponectin, leptin, leptin receptor)
8. Depressive mood (Center for Epidemiologic Studies Depression Scale [CESD])
9. Quality of life (Diabetes Quality of Life Clinical Trial Questionnaire [DSQLQ])
10. Nutrition intake

Overall trial start date

01/05/2006

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged greater than 18 years, either sex
2. Type 2 Diabetes
3. Participating in the Diabetes Exercise and Healthy Lifestyle Program of the Toronto Rehabilitation Institute

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. History of diagnosed cardiovascular disease
2. Contraindications to high intensity exercise participation:
2.1. Glaucoma
2.2. Retinopathy
2.3. Musculoskeletal limitations
2.4. Kidney disease
2.5. Balance impairments

Recruitment start date

01/05/2006

Recruitment end date

31/03/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Toronto Rehabilitation Institute
Toronto
M4G 1R7
Canada

Sponsor information

Organisation

Toronto Rehabilitation Institute (Canada)

Sponsor details

c/o Paul Oh
MD
347 Rumsey Road
Toronto
M4G 1R7
Canada
1 416 597 3422
oh.pauldr@torontorehab.on.ca

Sponsor type

Research organisation

Website

http://www.torontorehab.on.ca/

Funders

Funder type

Research organisation

Funder name

Toronto Rehabilitation Institute (Canada)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Canada

Funder name

Human Physiology Performance Laboratory (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Diabetes Association (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

Publication citations

Additional files

Editorial Notes