None listed
Conditions
Brief summary
Physical activity has well-proven positive outcomes among older people with stable chronic diseases such as diabetes and contributes to reduce the risk of disability and the use of health care resources. However, despite these well-known benefits, most of the older patients are inactive. TRIPL-A study addresses the challenge of physical activity promotion by testing an innovative exercise referral scheme model in older type 2 diabetic patients. TRIPL-A study is a randomized controlled trial with two parallel groups to investigate the efficacy of a new discontinued supervised aerobic training in promoting a more active lifestyle in inactive diabetic subjects. The study will be conducted at the Diabetology Unit of the IRCCS-INRCA Hospital of Ancona and at the Diabetology Unit of the ASUR Hospital of Fabriano. Both hospitals are situated in the Marche Region of the central Italy. Three hundred diabetic subjects with sedentary lifestyle (age range 65-74 years) will be enrolled in the study. Participants will be randomly assigned to either the control or the intervention arm with a 1:1 ratio, using a computerized permuted blocks randomization. Trial interventions will last 18 months. Patients assigned to the intervention arm will undertake a discontinuously supervised aerobic training program whereas patients assigned to the control arm will only receive the healthy lifestyle informative material and the lifestyle change counselling. A structured exercise program of 18 months, alternating supervised and non-supervised training periods lasting 3 months each (i.e. discontinued supervision), will be implemented. 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 web based application (WBA) to constantly update exercise prescription and control. 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 exercise training protocol will be created following the worldwide accepted recommendations and guidelines on health-enhancing PA for older adults and diabetic patients. Aerobic exercise intensity will be prescribed and monitored using heart rate (HR). The difference in sitting time and MET will be evaluated between intervention arm and comparator control arm in order to verify the efficacy of the discontinued supervised training program on the changes in lifestyle habits.
Interventions
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 superv
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).
Sponsors
IRCCS-INRCA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
65 Years to 74 Years
Healthy volunteers
No
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
Exclusion criteria
- ß-blockers therapy or any other drug that could affect heart rate, either at rest or in response to aerobic exercise; - chronic obstructive pulmonary disease; - life expectancy < 6 months - severe cardiovascular disease (including New York Heart Association [NYHA] class III or IV congestive heart failure), clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina that that would interfere with the ability to participate fully in either study arm - history of myocardial infarction, transient ischemic attack or stroke in the previous six months - under any condition that, according to the clinical judgement of the investigator, might harm the patient if participating in the trial; - physically active according to the results of the International Physical Activity Questionnaire (IPAQ) - not able to complete the Long Distance Corridor Walk (LDCW) without an assistive device
Outcome results
None listed