Trial Review

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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
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
Secondary ID [1] 295346 0
None
Universal Trial Number (UTN)
Trial acronym
TRIPL-A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary lifestyle 308553 0
older age 308554 0
frailty 308557 0
type 2 diabetes 308558 0
Condition category
Condition code
Metabolic and Endocrine 307518 307518 0 0
Diabetes
Public Health 307519 307519 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 301668 0
Lifestyle
Comparator / control treatment
Healthy lifestyle informative material designed specifically for this study (brochures to promote physical activity and healthy diet)
Control group
Placebo

Outcomes
Primary outcome [1] 306493 0
Difference in sitting time per week calculated by the International Physical Activity Questionnaire (IPAQ) between experimental arm and placebo comparator arm
Timepoint [1] 306493 0
6 months, 12 months (primary endpoint), 18 months post-intervention commencement
Primary outcome [2] 306494 0
Difference in Metabolic Equivalent (MET) per week calculated by the IPAQ interview between experimental arm and placebo comparator arm
Timepoint [2] 306494 0
6 months, 12 months (primary endpoint), 18 months post-intervention commencement
Secondary outcome [1] 348662 0
Difference in VO2 max calculated by the Long Distance Corridor Walk (LDCW) test between experimental arm and placebo comparator arm
Timepoint [1] 348662 0
6 months, 12 months, 18 months post-intervention commencement
Secondary outcome [2] 348663 0
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).
Timepoint [2] 348663 0
6 months, 12 months, 18 months post-intervention commencement
Secondary outcome [3] 348664 0
Difference in quality of life calculated by Euro-QoL (EQ 5D) between experimental arm and placebo comparator arm.
Timepoint [3] 348664 0
6 months, 12 months, 18 months post-intervention commencement
Secondary outcome [4] 348665 0
Difference in sleep disorders evaluated by the Pittsburgh Sleep Quality Index (PSQI) between experimental arm and placebo comparator arm
Timepoint [4] 348665 0
6 months, 12 months, 18 months post-intervention commencement
Secondary outcome [5] 348666 0
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).
Timepoint [5] 348666 0
6 months, 12 months, 18 months post-intervention commencement
Secondary outcome [6] 348999 0
Difference in waist circumference evaluated by a tape measure between experimental arm and placebo comparator arm
Timepoint [6] 348999 0
6 months, 12 months, 18 months post-intervention commencement
Secondary outcome [7] 349000 0
difference in blood pressure and heart rate measured by manual sphygmomanometer between experimental arm and placebo comparator arm.
Timepoint [7] 349000 0
6 months, 12 months, 18 months post-intervention commencement

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
Minimum age
65 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
9/12/2015
Date of last participant enrolment
Anticipated
Actual
30/03/2017
Date of last data collection
Anticipated
30/09/2018
Actual
Sample size
Target
300
Accrual to date
Final
307
Recruitment outside Australia
Country [1] 10592 0
Italy
State/province [1] 10592 0

Funding & Sponsors
Funding source category [1] 299939 0
Government body
Name [1] 299939 0
Ministry of Health
Country [1] 299939 0
Italy
Primary sponsor type
Other
Name
IRCCS-INRCA
Address
via della Montagnola 81 - I-60127, Ancona, Italy
Country
Italy
Secondary sponsor category [1] 299316 0
None
Name [1] 299316 0
None
Address [1] 299316 0
None
Country [1] 299316 0
Other collaborator category [1] 280208 0
Hospital
Name [1] 280208 0
Diabetology Unit, Azienda Sanitaria Unica Regione (ASUR) Marche
Address [1] 280208 0
Via Marconi, n° 9 - I-60044, Fabriano, Italy
Country [1] 280208 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300804 0
Comitato Etico Regionale delle Marche
Ethics committee address [1] 300804 0
Azienda Ospedaliera Universitaria Ospedali Riuniti, Via Conca, I-60126, Torrette di Ancona, Italy
Ethics committee country [1] 300804 0
Italy
Date submitted for ethics approval [1] 300804 0
31/07/2015
Approval date [1] 300804 0
22/10/2015
Ethics approval number [1] 300804 0
CERM 2015 333 IN 15011

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84870 0
Dr Anna Rita Bonfigli
Address 84870 0
Scientific Direction, IRCCS INRCA, Via della Montagnola 81, I-60127 Ancona, Italy
Country 84870 0
Italy
Phone 84870 0
+ 39 071 800 3719
Fax 84870 0
Email 84870 0
a.bonfigli@inrca.it
Contact person for public queries
Name 84871 0
Dr Anna Rita Bonfigli
Address 84871 0
Scientific Direction, IRCCS INRCA, Via della Montagnola 81, I-60127, Ancona , Italy
Country 84871 0
Italy
Phone 84871 0
+ 39 071 800 3719
Fax 84871 0
Email 84871 0
a.bonfigli@inrca.it
Contact person for scientific queries
Name 84872 0
Dr Anna Rita Bonfigli
Address 84872 0
Scientific Direction, IRCCS INRCA, Via della Montagnola 81, I-60127, Ancona, Italy
Country 84872 0
Italy
Phone 84872 0
+ 39 071 800 3719
Fax 84872 0
Email 84872 0
a.bonfigli@inrca.it

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
SourceTitleYear of PublicationDOI
EmbaseDiscontinuously 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.2019https://dx.doi.org/10.1186/s12877-018-1022-x
N.B. These documents automatically identified may not have been verified by the study sponsor.