Contact information
Type
Scientific
Primary contact
Dr Ron Sigal
ORCID ID
Contact details
7th floor
North Tower
Foothills Medical Center
1403 29 Street NW
Calgary
Alberta
T2N 2T9
Canada
+1 403 944 2783
rsigal@ucalgary.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00410436
Protocol/serial number
MCT-80682
Study information
Scientific title
Resistance Exercise in Already-active Diabetic Individuals (READI): a multicentre, two arm, randomised parallel trial
Acronym
READI
Study hypothesis
Primary hypothesis:
In type one diabetic individuals who already engage in regular aerobic exercise, adding a six-month resistance training program will result in improved glycaemic control as reflected in reduced HbA1c compared to aerobic training alone.
Secondary hypotheses:
In type one diabetic individuals who already do regular aerobic exercise, adding a six-month resistance training program will have favourable effects on body composition, non-traditional and traditional Cardiovascular Disease (CVD) risk factors, and quality of life versus aerobic exercise alone (note: sample size was calculated solely based on having adequate statistical power for the primary outcome).
Exploratory research questions without a-priori hypotheses:
1. What is the incremental effect of resistance training on insulin requirements and frequency of hypoglycaemia?
2. Do changes in glycaemic control, body composition, or quality of life during the resistance training intervention predict exercise participation during the subsequent six months?
3. How cost-effective is it to add the resistance training program?
Ethics approval
Received from the Research Ethics Board of the Ottawa Hospital, Ottawa, Ontario (Canada) on the 8th July 2005 (ref: 2005301-01H) and the Research Ethics Board of the Children's Hospital of Eastern Ontario, Ottawa, Ontario (Canada) on the 25th July 2005 (ref: 05/30E).
Study design
Multicentre, two arm, randomised parallel trial with study investigator, personnel involved in insulin adjustment, and outcome assessor blinded.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type one diabetes mellitus
Intervention
Intervention:
Resistance exercise training, three times per week, beginning with one to two sets of eight exercises at moderate intensity, high repetition training and progressing to three sets, eight repetitions of eight exercises at 8RM for 22 weeks. Subjects will continue performing aerobic exercise at the same volume, duration and intensity as they did at baseline.
Control:
Waiting-list control, subjects will continue performing aerobic exercise at the same volume, duration and intensity as they did at baseline; they will not perform any resistance training activity for 22 weeks.
Contact for public queries:
Diana Mitchell, RN, BN, CDE, CCRC
Tel: +1 403 943 2494
Email: mitcheld@ucalgary.ca
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
HbA1c at the end of the six-month supervised exercise period, adjusted by Analyses of Covariance (ANCOVA) for HbA1c at randomisation, measured at baseline, 1 month, 3 months, 6 months and 12 months.
Secondary outcome measures
1. Body composition, baseline and six months
2. Non-traditional CVD risk factors measured at one month (pre-randomisation) and six months:
2.1. Low density lipoprotein (LDL) particle diameter
2.2. Apolipoprotein B (Apo-B)
2.3. Apolipoprotein A1 (Apo-A1)
2.4. Apo-B/Apo-A1 ratio
2.5. Urinary albumin to creatinine ratio
2.6. Serum C-reactive protein
2.7. Free fatty acids (FFA)
3. Traditional metabolic CVD risk factors, measured at baseline, 1 month (pre-randomisation), and at 3, 6, and 12-months:
3.1. High density lipoprotein (HDL) cholesterol
3.2. LDL cholesterol
3.3. Triglycerides
3.4. Total/HDL cholesterol ratio
3.5. Systolic and diastolic blood pressure
4. Quality of Life, baseline, 1 month (pre-randomisation), 3, 6, and 12 months:
4.1. Diabetes-Specific Quality of Life scale
4.2. Medical Outcomes Study Short Form-36
4.3. EuroQol EQ-5
Overall trial start date
01/10/2006
Overall trial end date
31/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type one diabetes mellitus as defined by the 2003 Canadian Diabetes Association (CDA) guidelines with duration greater than or equal to one year, requiring insulin therapy starting within one year of diagnosis and continuously thereafter
2. Male or female, aged greater than or equal to 16 years, HbA1c 0.066 - 0.099 (normal non-diabetic range 0.040 - 0.060)
3. Habitual performance during the previous four months of aerobic exercise greater than or equal to three times per week, including at least 90 minutes per week of vigorous aerobic exercise (of sufficient intensity to cause sweating, e.g., jogging, soccer, basketball, racquet sports), and/or greater than or equal to 150 minutes per week of aerobic exercise of at least moderate intensity (e.g., brisk walking, moderate-paced bicycling) but no resistance training. Subjects must agree to maintain their habitual volume and intensity of aerobic activity during run-in and intervention periods, minimising variation due to seasons, but they will be permitted to vary specific exercises chosen.
4. Willingness and ability to work closely with the study physicians, nurse and dietician and follow their recommendations for insulin therapy and adjustments of diet
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
104
Participant exclusion criteria
1. Participation during the previous four months in any resistance training
2. Hypoglycaemia unawareness, or severe hypoglycaemia requiring assistance from another person within the previous three months
3. "Brittle" diabetes, characterised by frequent and unpredictable hypoglycaemia (even if not requiring assistance from others) and hyperglycaemia
4. Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis
5. Known or suspected clinically significant gastroparesis
6. Body mass index greater than 35 kg/m^2, or weight greater than 147 kg (exceeding capacity of dual energy X-ray absorptiometry [DEXA] or computed tomography [CT] scanners)
7. Fasting serum c-peptide greater than or equal to 0.2 nmol/l
8. Increase or decrease of greater than or equal to 5% of body weight during the previous two months
9. An expected requirement within the subsequent six months for medications (other than insulin) that will affect glucose metabolism (e.g., corticosteroids)
10. If age is less than 18 years, linear growth of greater than or equal to 1 cm during the previous year
11. Significant renal disease: serum creatinine greater than or equal to 200 mEq/l or proteinuria greater than 1 g/24 hours
12. Uncontrolled hypertension: blood pressure (BP) greater than 150 mmHg systolic or greater than 95 mmHg diastolic in a sitting position
13. Other illness, judged by the patient or investigators to make participation in this study inadvisable
14. Cognitive deficit resulting in inability to understand or comply with instructions
15. Pregnancy at the start of the study, or intention to become pregnant in the next year
16. Inability to communicate in English or French
17. Ischaemic alectrocardiogram (ECG) changes during baseline maximal cardiopulmonary stress test, unless subsequently cleared for participation by a cardiologist after appropriate investigation
18. Low aerobic fitness: aerobic fitness more than 15% below the mean for age and gender, based on baseline maximal treadmill exercise test. This criterion is included in order to reduce likelihood of candidates entering the trial by exaggerating their habitual activity. Very few people engaging in regular aerobic activity would have such low treadmill performance
19. Unwillingness to sign informed consent
Recruitment start date
01/10/2006
Recruitment end date
31/10/2010
Locations
Countries of recruitment
Canada
Trial participating centre
7th floor, North Tower
Alberta
T2N 2T9
Canada
Sponsor information
Organisation
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
Sponsor details
725 Parkdale Avenue
Ottawa
Ontario
K1Y 4E9
Canada
+1 613 761 4395
info@ohri.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-80682)
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