This is a pragmatic, non-inferiority clinical trial, enrolling heart failure patients who will be randomized to a 12-week exercise training program either centre-based or home-based with telemonitoring. The impact of this intervention will be assessed on established surrogate markers in HF such as maximal exercise capacity, plasma biomarkers and quality of life. The cost-effectiveness and overall satisfaction with the treatment will also be studied. In addition to measure the clinical and economic impact of this innovative way of delivering exercise, it is intended to unravel new molecular pathways and assess a pool of biomarkers that provide a wide mechanistic picture underlying the clinical effects of exercise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital or at home.
Centro Hospitalar do Porto
Porto, Portugal
Peak oxygen uptake (ml/kg/min)
Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 3 moths
Time frame: Change from baseline in peak oxygen uptake (ml/kg/min) at 3 months
6-min walk test (6MWT) distance
Changes in distance from the 6MWT.
Time frame: Change from baseline to 3 months, and to 12 months.
Health status (EQ-5D-5L)
Health status will be evaluated by the 5-level EQ-5D version (EQ-5D-5L) questionnaire. The questionnaire comprises five dimensions, each describing a different aspect of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has five response levels of severity which range from 0 (no problems) to 5 (extreme problems/ unable to do). In addition, there is a score of overall health range from 0 to 100%.
Time frame: Change from baseline to 3 months, and to 12 months.
Health-related quality of life (MLHFQ)
Health-related quality of life will be evaluated by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is composed of 21 questions rated on a scale from 0 (no effect) to 5 (very much). The questionnaire is scored by summation of all 21 responses, where higher scores indicate worse quality of life.
Time frame: Change from baseline to 3 months, and to 12 months.
Anxiety and Depression (HADS)
Anxiety and Depression will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire is composed of 14 questions on a four-point (0-3) scale. The possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. A score of 0 to 7 for either subscale will be regarded as being in the normal range, a score of 11 or higher indicating probable presence of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.
Time frame: Change from baseline to 3 months, and to 12 months.
Disutility
Individual disutility (inconvenience) perceived by patients and respective quality of life gains. Longevity to offset the exercise program disutility will be expressed in days.
Time frame: Evaluate at 3th month
Physical activity (steps/day)
Physical activity will be assessed by a POLAR-M200 device with the numbers of daily steps.
Time frame: Change from baseline to 3 months, and to 12 months.
Daily physical activity levels (min/day)
Daily physical activity levels it will be measure with a POLAR-M200 device. Measures will be described as time spend in light physical activity, moderate and vigorous physical activity, and spend sitting or lying (minutes per day).
Time frame: Change from baseline to 3 months, and to 12 months.
Dyspnea
Dyspnea will be evaluated by the Dyspnea-12 (D-12) questionnaire. The D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items. Total scores from the D-12 range from 0 to 36, with higher scores corresponding to greater severity.
Time frame: Change from baseline to 3 months, and to 12 months.
Mediterranean diet
Adherence to Mediterranean diet will be evaluated by the 14-Item Mediterranean Diet Assessment Tool (MEDAS-14). The answer to each of the 14 items is scored with 1 in the case of meeting the criteria defined as typical of this type of food (range of possible variation 0-14 points). A total score ≥10 as represent a good adherence to the Mediterranean diet.
Time frame: Change from baseline to 3 months, and to 12 months.
Hand grip strength
Hand grip strength will be assessed by Jamar dynamometer (kg)
Time frame: Change from baseline to to 3 and to 12 months.
Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase
These markers will inform endothelial function, damage and repair
Time frame: Change from baseline to 3 months
Biomarkers (pg/ml)
NTproBNP and ST2 (pg/ml)
Time frame: Change from baseline to 3 months
Biomarkers (mg/L)
hsCRP and Troponin (mg/L)
Time frame: Change from baseline to 3 months
Concentration of plasma exosomes
Plasma exosomes will be isolated using microbead-based sorting techniques and characterized by nanoparticle tracking analysis, Western blot, and quantitative real-time polymerase chain reaction assessments
Time frame: Change from baseline to 3 months
Percentage of protein aggregates
Protein aggregates (%) will be analysed using a diagonal two-dimensional (D2D) SDS-PAGE assay with mass spectrometry to identify and characterize detergent-resistant protein aggregates in plasma pre-cleared from albumin and immunoglobulin.
Time frame: Change from baseline to 3 months
Cost-effectiveness of home-based exercise Vs. clinical-base exercise
Compare cost effectiveness analysis of home-based exercise Vs. clinical-base exercise. The main outcome measure for this study will be cost per quality adjusted life year (QALY)
Time frame: At 12th month
Physical fitness levels evaluation
Physical fitness levels will be evaluated by the Senior Fitness test
Time frame: Change from baseline to 3 and to 12 months.
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