The "TRIPL-A Study". A TRIal to promote PhysicaL Activity among patients in the young-old age affected by Type 2 diabetes

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: Intervention arm participants will undergo a structured aerobic exercise program of 18 months, alternating supervised and non‐supervised training periods lasting 3 months each (i.e. discontinued supervision). Participants will train 3 times per week, with at least 48 h between each exercise session. During the three trimesters (trim) of supervised training (trim 1: 1st to 3rd month; trim 3: 7th to 9th month; trim 5: 13th to 15th month), patients will exercise in a fitness center under the supervision of the exercise specialist, who will use a dedicated web‐based application (WBA) to constantly update exercise prescription and control data. In the non‐supervised training trimesters (trim 2: 4th to 6th month; trim 4: 10th to 12th month; trim 6: 16th to 18th month) participants will train autonomously and will use the WBA to access their own aerobic training schedule and parameters (duration and intensity). They will also input into the WBA the actual workout performed at the end of each self‐monitored exercise session. The aerobic training protocol will follow the worldwide accepted recommendations and guidelines on health‐enhancing PA for older adults and T2D patients, and will be supervised by exercise specialists (i.e., in Italy, by trainers with a M.Sc. in “Physical activity for health and prevention”). Exercise intensity will be prescribed, monitored, and tailored using the heart rate reserve (HRR). Individual heart rate response to each exercise session will be used to prescribe a tailored aerobic exercise intensity for the subsequent session. Supervised sessions will start and end with brief warm‐up and cool‐down aerobic exercise phases (5 mins each), followed by simple stretching exercises. The in‐between stimulus phase will employ aerobic exercise that will gradually and progressively increase, throughout the study, in both duration (trim 1: 20 to 30 min; trim 3: 30 to 40 mins; trim 5: 40 to 50 mins) and intensity (trim 1: 40‐50%HRR; trim 3: 45‐55%HRR; trim 5: 50‐60%HRR). Treadmill, bike (both upright and recumbent), elliptical, rower, and upper body ergometers will be available to exercise aerobically. Non‐supervised sessions will use duration and intensity achieved at the end of each supervised trimester as reference for duration (trim 2: ˜30 min; trim 4: ˜40 mins; trim 6: ˜50 mins) and intensity (trim 2: ˜50%HRR; trim 4:˜55%HRR; trim 6: ˜60%HRR) of the self‐administered aerobic exercises (any aerobic exercise will be allowed). CONDITION: frailty older age sedentary lifestyle type 2 diabetes PRIMARY OUTCOME: Difference in Metabolic Equivalent (MET) per week calculated by the IPAQ interview between experimental arm and placebo comparator arm Difference in sitting time per week calculated by the International Physical Activity Questionnaire (IPAQ) between experimental arm and placebo comparator arm SECONDARY OUTCOME: Difference in health care resources consumption between experimental arm and placebo comparator arm. ; Resources consumption will be evaluated by a questionnaire prepared for the study in order to establish the direct medical costs (outpatients visits to medical specialists, hospital admission, visits to general practitioner and use of medication). difference in blood pressure and heart rate measured by manual sphygmomanometer between experimental arm and placebo comparator arm. Difference in body mass index (BMI) between experimental arm and placebo comparator arm. INCLUSION CRITERIA: age range (years): 65 to 74; diagnosis of type 2 diabetes sedentary lifestyle (less than 15 min/day of moderate and/or vigorous activity using the the IPAQ interview ; Height and weight will be evaluated by a digital scale with height meter (PEGASO). Difference in quality of life calculated by Euro‐QoL (EQ 5D) between experimental arm and placebo comparator arm. Difference in sleep disorders evaluated by the Pittsburgh Sleep Quality Index (PSQI) between experimental arm and placebo comparator arm Difference in VO2 max calculated by the Long Distance Corridor Walk (LDCW) test between experimental arm and placebo comparator arm Difference in waist circumference evaluated by a tape measure between experimental arm and placebo comparator arm
Epistemonikos ID: aeaa6cce8969988587fc447d3622a79e8ce7f57a
First added on: Aug 24, 2024