Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT02009995
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged \>35 years with T2D as defined by the CDA Expert Committee.
2. A1C values within range of 6.6%-9.9%.
3. Willingness to follow study procedures (e.g. wear the accelerometer for exercise sessions and download them at least weekly, complete exercise logs, attend supervised group-based resistance band sessions, perform resistance bands exercise at home).
Exclusion Criteria:
1. Participation in a regular program of physical conditioning or aerobic sports/activities for \>150 minutes per week during the 6 months prior to enrolment.
2. Participation in any resistance exercise training during the previous 6 months.
3. Requirement for insulin therapy currently or in the previous 3 months.
4. Uncontrolled hyperglycemia (A1C \> 10%), as it would be a clear indication for cointervention.
5. Uncontrolled hypertension: systolic BP \>160 mmHg or diastolic BP \>100 mmHg, both measured in sitting position. If too-high A1C or BP is the only reason for exclusion, subjects will be asked to see their physicians regarding the hyperglycemia or BP, and invited to re-apply for the study several months later if the problem is under better control.
6. Hypo-glycemia unawareness, or severe hypoglycemia requiring assistance from another person within the previous 3 months.
7. Restrictions in physical activity due to disease: unstable cardiac or pulmonary disease, severe aortic stenosis, Marfan's syndrome (risk of aortic dissection from resistance training), intermittent claudication sufficient to interfere with aerobic exercise progression, severe peripheral neuropathy or active proliferative retinopathy, disabling stroke, severe arthritis, musculoskeletal injuries compromising safety of the prescribed exercises, inability to walk 10 minutes.
8. Other illness, judged by the patient or study physician to make participation in this study inadvisable.
9. Inability to understand or comply with instructions.
10. Pregnancy at the start of the study, or intention to become pregnant in the next 6 months.
11. Plans to move to a different city within the next 12 months.
12. Inability to communicate in English or French.
13. Unwillingness to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT02009995
Study Brief:
Protocol Section:
NCT02009995