Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/06/2007
Date assigned
22/06/2007
Last edited
19/01/2010
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 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

http://www.ohri.ca/

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

Publication citations

Additional files

Editorial Notes