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Trial registered on ANZCTR
Registration number
ACTRN12618001164280
Ethics application status
Approved
Date submitted
28/06/2018
Date registered
13/07/2018
Date last updated
13/07/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
The "TRIPL-A Study". A TRIal to promote PhysicaL Activity among patients in the young-old age affected by Type 2 diabetes
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Scientific title
The "TRIPL-A Study". A TRIal to promote PhysicaL Activity among patients in the young-old age affected by Type 2 diabetes: the TRIPL-A protocol for a randomized controlled trial to assess the efficacy of a discontinued supervised aerobic training on sedentary lifestyle
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Secondary ID [1]
295346
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None
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Universal Trial Number (UTN)
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Trial acronym
TRIPL-A
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
sedentary lifestyle
308553
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older age
308554
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frailty
308557
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type 2 diabetes
308558
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Condition category
Condition code
Metabolic and Endocrine
307518
307518
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0
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Diabetes
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Public Health
307519
307519
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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: Ëś30 min; trim 4: Ëś40 mins; trim 6: Ëś50 mins) and intensity (trim 2: Ëś50%HRR; trim 4:Ëś55%HRR; trim 6: Ëś60%HRR) of the self-administered aerobic exercises (any aerobic exercise will be allowed).
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Intervention code [1]
301668
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Lifestyle
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Comparator / control treatment
Healthy lifestyle informative material designed specifically for this study (brochures to promote physical activity and healthy diet)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Difference in sitting time per week calculated by the International Physical Activity Questionnaire (IPAQ) between experimental arm and placebo comparator arm
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Assessment method [1]
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Timepoint [1]
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6 months, 12 months (primary endpoint), 18 months post-intervention commencement
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Primary outcome [2]
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Difference in Metabolic Equivalent (MET) per week calculated by the IPAQ interview between experimental arm and placebo comparator arm
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Assessment method [2]
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Timepoint [2]
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6 months, 12 months (primary endpoint), 18 months post-intervention commencement
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Secondary outcome [1]
348662
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Difference in VO2 max calculated by the Long Distance Corridor Walk (LDCW) test between experimental arm and placebo comparator arm
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Assessment method [1]
348662
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Timepoint [1]
348662
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6 months, 12 months, 18 months post-intervention commencement
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Secondary outcome [2]
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Difference in body mass index (BMI) between experimental arm and placebo comparator arm.
Height and weight will be evaluated by a digital scale with height meter (PEGASO).
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Assessment method [2]
348663
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Timepoint [2]
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6 months, 12 months, 18 months post-intervention commencement
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Secondary outcome [3]
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Difference in quality of life calculated by Euro-QoL (EQ 5D) between experimental arm and placebo comparator arm.
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Assessment method [3]
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Timepoint [3]
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6 months, 12 months, 18 months post-intervention commencement
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Secondary outcome [4]
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Difference in sleep disorders evaluated by the Pittsburgh Sleep Quality Index (PSQI) between experimental arm and placebo comparator arm
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Assessment method [4]
348665
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Timepoint [4]
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6 months, 12 months, 18 months post-intervention commencement
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Secondary outcome [5]
348666
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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).
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Assessment method [5]
348666
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Timepoint [5]
348666
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6 months, 12 months, 18 months post-intervention commencement
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Secondary outcome [6]
348999
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Difference in waist circumference evaluated by a tape measure between experimental arm and placebo comparator arm
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Assessment method [6]
348999
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Timepoint [6]
348999
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6 months, 12 months, 18 months post-intervention commencement
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Secondary outcome [7]
349000
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difference in blood pressure and heart rate measured by manual sphygmomanometer between experimental arm and placebo comparator arm.
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Assessment method [7]
349000
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Timepoint [7]
349000
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6 months, 12 months, 18 months post-intervention commencement
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Eligibility
Key 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
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Minimum age
65
Years
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Maximum age
74
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Given an expected drop-out rate of 20%, the expected sample size of 300 subjects is sufficient to detect a decrease by 10% in the number of sedentary older people at the end of the trial, with a statistical power of 0.9 and a significance level of 0.05.
Following an exploratory bivariate analysis, the effect of the intervention on patients’ outcomes will be analyzed at multivariate level by means of logistic regression models (for dichotomous variables, e.g. sedentary vs. active) and analysis of covariance for continuous variables such as the 400 meters walking test, the quality of life, but also the use of health care resources.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
9/12/2015
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Date of last participant enrolment
Anticipated
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Actual
30/03/2017
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Date of last data collection
Anticipated
30/09/2018
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Actual
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Sample size
Target
300
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Accrual to date
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Final
307
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Recruitment outside Australia
Country [1]
10592
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Italy
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State/province [1]
10592
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Funding & Sponsors
Funding source category [1]
299939
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Government body
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Name [1]
299939
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Ministry of Health
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Address [1]
299939
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Viale Giorgio Ribotta, 5 - 00144 - Roma, Italy
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Country [1]
299939
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Italy
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Primary sponsor type
Other
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Name
IRCCS-INRCA
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Address
via della Montagnola 81 - I-60127, Ancona, Italy
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Country
Italy
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Secondary sponsor category [1]
299316
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None
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Name [1]
299316
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None
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Address [1]
299316
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None
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Country [1]
299316
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Other collaborator category [1]
280208
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Hospital
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Name [1]
280208
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Diabetology Unit, Azienda Sanitaria Unica Regione (ASUR) Marche
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Address [1]
280208
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Via Marconi, n° 9 - I-60044, Fabriano, Italy
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Country [1]
280208
0
Italy
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300804
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Comitato Etico Regionale delle Marche
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Ethics committee address [1]
300804
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Azienda Ospedaliera Universitaria Ospedali Riuniti, Via Conca, I-60126, Torrette di Ancona, Italy
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Ethics committee country [1]
300804
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Italy
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Date submitted for ethics approval [1]
300804
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31/07/2015
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Approval date [1]
300804
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22/10/2015
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Ethics approval number [1]
300804
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CERM 2015 333 IN 15011
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
84870
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Dr Anna Rita Bonfigli
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Address
84870
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Scientific Direction, IRCCS INRCA, Via della Montagnola 81, I-60127 Ancona, Italy
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Country
84870
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Italy
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Phone
84870
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+ 39 071 800 3719
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Fax
84870
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Email
84870
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[email protected]
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Contact person for public queries
Name
84871
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Dr Anna Rita Bonfigli
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Address
84871
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Scientific Direction, IRCCS INRCA, Via della Montagnola 81, I-60127, Ancona , Italy
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Country
84871
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Italy
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Phone
84871
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+ 39 071 800 3719
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Fax
84871
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Email
84871
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[email protected]
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Contact person for scientific queries
Name
84872
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Dr Anna Rita Bonfigli
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Address
84872
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Scientific Direction, IRCCS INRCA, Via della Montagnola 81, I-60127, Ancona, Italy
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Country
84872
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Italy
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Phone
84872
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+ 39 071 800 3719
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Fax
84872
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Email
84872
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Discontinuously supervised aerobic training vs. physical activity promotion in the self-management of type 2 diabetes in older Italian patients: design and methods of the 'TRIPL-A' randomized controlled trial.
2019
https://dx.doi.org/10.1186/s12877-018-1022-x
N.B. These documents automatically identified may not have been verified by the study sponsor.
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