Diabetes type 2 Diabetes mellitus (T2DM)
Conditions
Interventions
Patients will be randomized to one of two groups, i.e. (1) low volume
high-intensity resistance training + usual care, (2) usual care. The
intervention consists of 20-30 minute training sessions onc
Blood glucose
Diabetes Mellitus
Resistance training
Sponsors
Stichting Thuiszorg West-Brabant
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosis of T2DM by the American Diabetes Association criteria, i.e. a) HbA1c >=6.5%, or b) fasting plasma glucose >=7.0 mmol/L, or c) 2-h plasma glucose >=11.1 mmol/L. (2) Baseline HbA1c value of 6.6% to 9.9% (normal range, 4.0% to 6.0%). (3) Minimum age of 18 years.
Exclusion criteria
Exclusion criteria: (1) Current insulin therapy. (2) Participation in exercise 2 or more times weekly for 20 minutes or longer per session or in any resistance training during the previous 6 months. (3) Insufficient mastery of the Dutch language. (4) Cognitive impairment (5) Changes during the previous 2 months in oral hypoglycemic, antihypertensive,or lipid-lowering agents or body weight (>=5%). (6) Serum creatinine level of 200 µmol/L or greater (>=2.26 mg/dL). (7) Proteinuria greater than 1 g/d. (8) Blood pressure greater than 160/100 mm Hg. (9) Restrictions in physical activity because of disease. (10) Presence of other medical conditions that made participation inadvisable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) glycemic control The absolute change in plasma glycosylated haemoglobin concentration (HbA1c [%]) from baseline to the end of the intervention period between both groups will be assessed as main outcome for glycemic control. In addition fasting plasma glucose (mmol/L) will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| (2) Feasibility Feasibility will be assessed on the basis of retention, adherence and adverse events. For retention the attrition rate will be established, defined as discontinuation of the intervention or loss to follow-up following randomization or by the end of the intervention period. Adherence will be measured through attendance to the exercise sessions and compliance to the prescribed intensities. All exercise sessions will be monitored by study personnel who note attendance in a log and ensure each participant completes each exercise bout at the individually prescribed intensity and duration. (3) Risk factors for cardiovascular disease i. Blood pressure Both systolic and diastolic blood pressure (mmHg) will be measured. ii. Plasma lipid values The total cholesterol, HDL cholesterol and LDL cholesterol levels (mmol/L) will be assessed. iii. Body composition Body weight (kg) and height (m) will be assessed and will be used to establish the Body Mass Index (BMI [kg/mm2]). In addition, the waist circumference (cm) will be measured. (4) Muscle strength Strength testing involves determination of the maximum weight (kg) that can be lifted 1 time while maintaining proper form (1RM). Testing will be done for 2 exercises that are included in the training program (chest press and leg press). In addition, the maximal voluntary torque (MVT) of the knee extensor muscles will be determined isometrically on a custom-made dynamometer (Faculty of Human Movement Sciences, VU University Amsterdam, Netherlands). (5) Physical functioning For physical functioning endurance, walking speed and balance will be assessed. Endurance testing involves determination of the distance walked (m) during the Six-Minute Walk Test (6MWT). Walking speed and balance will be assessed with the 10 meter walk test (10MWT) and the Balance Test, both of which are included in the Short Physical Performance Battery (SPPB), a short performance battery assessing lower extremity | — |
Countries
The Netherlands
Outcome results
None listed