Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Between-groups differences in systolic blood pressure |
Casual (resting) measures of systolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. |
3 months |
|
Primary |
Between-groups differences in diastolic blood pressure |
Casual (resting) measures of diastolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. |
3 months |
|
Secondary |
Between-groups differences in systolic blood pressure |
Casual (resting) measures of systolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. |
4 months |
|
Secondary |
Between-groups differences in diastolic blood pressure |
Casual (resting) measures of diastolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. |
4 months |
|
Secondary |
Between-groups differences in mean blood pressure |
Casual (resting) blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. |
3 months |
|
Secondary |
Between-groups differences in mean blood pressure |
Casual (resting) blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. |
4 months |
|
Secondary |
Between-groups differences in total cholesterol |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
3 months |
|
Secondary |
Between-groups differences in total cholesterol |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
4 months |
|
Secondary |
Between-groups differences in high-density lipoprotein cholesterol |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
3 months |
|
Secondary |
Between-groups differences in high-density lipoprotein cholesterol |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
4 months |
|
Secondary |
Between-groups differences in low-density lipoprotein cholesterol |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
3 months |
|
Secondary |
Between-groups differences in low-density lipoprotein cholesterol |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
4 months |
|
Secondary |
Between-groups differences in triglycerides |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
3 months |
|
Secondary |
Between-groups differences in triglycerides |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
4 months |
|
Secondary |
Between-groups differences in glycosylated hemoglobin |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
3 months |
|
Secondary |
Between-groups differences in glycosylated hemoglobin |
Will be analysed using standardised methods, using relevant commercial enzymatic test kits. |
4 months |
|
Secondary |
Between-groups differences in resting heart rate |
Number of heart beats per minute, measured by heart rate monitors. |
3 months |
|
Secondary |
Between-groups differences in resting heart rate |
Number of heart beats per minute, measured by heart rate monitors. |
4months |
|
Secondary |
Between-groups differences in maximum oxygen consumption |
Determined by pulmonary gas exchange measurements. |
3 months |
|
Secondary |
Between-groups differences in maximum oxygen consumption |
Determined by pulmonary gas exchange measurements. |
4 months |
|
Secondary |
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test) |
Number of meters covered. |
3 months |
|
Secondary |
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test) |
Number of meters covered. |
4 months |
|
Secondary |
Between-groups differences in body mass index |
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2) |
3 months |
|
Secondary |
Between-groups differences in body mass index |
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2) |
4 months |
|
Secondary |
Between-groups differences in bone density (measured by DEXA in g/cm2) |
bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (g / cm2 - grams of bone mineral content per area or analyzed bone cm2). |
3 months |
|
Secondary |
Between-groups differences in bone density (measured by DEXA in g/cm2) |
bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (g / cm2 - grams of bone mineral content per area or analyzed bone cm2). |
4 months |
|
Secondary |
Between-groups differences in bone content (measured by DEXA in grams) |
bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams) |
3 months |
|
Secondary |
Between-groups differences in bone content (measured by DEXA in grams) |
bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams) |
4 months |
|
Secondary |
Between-groups differences in lean mass (measured by DEXA in kg) |
measured by Dual Energy X-ray Absorptiometry (kg) |
3 months |
|
Secondary |
Between-groups differences in lean mass (measured by DEXA in kg) |
measured by Dual Energy X-ray Absorptiometry (kg) |
4 months |
|
Secondary |
Between-groups differences in body fat (measured by DEXA in %) |
measured by Dual Energy X-ray Absorptiometry (%) |
3 months |
|
Secondary |
Between-groups differences in body fat (measured by DEXA in %) |
measured by Dual Energy X-ray Absorptiometry (%) |
4 months |
|
Secondary |
Between-groups differences in body mass (measured by DEXA in kg) |
measured by Dual Energy X-ray Absorptiometry (kg) |
3 months |
|
Secondary |
Between-groups differences in body mass (measured by DEXA in kg) |
measured by Dual Energy X-ray Absorptiometry (kg) |
4 months |
|
Secondary |
Between-groups differences in postural balance |
measured by a modified Flamingo test |
3 months |
|
Secondary |
Between-groups differences in postural balance |
measured by a modified Flamingo test |
4 months |
|
Secondary |
Between-groups differences in lower body strength |
measured by a counter-movement jump test |
3 months |
|
Secondary |
Between-groups differences in lower body strength |
measured by a counter-movement jump test |
4 months |
|
Secondary |
Between-groups differences in quality of life |
measured by WHOQOL-BREF questionnaire |
3 months |
|
Secondary |
Between-groups differences in quality of life |
measured by WHOQOL-BREF questionnaire |
4 months |
|