AIMS AND HYPOTHESIS
The main aim is to assess in a pragmatic clinical trial the clinical and economic impact of a clinic-based versus homebased exercise intervention in patients with HFpFE. The following key aims will be evaluated:
# Aim 1: To compare the impact of a clinic-based versus home-based exercise training intervention with telemonitoring on maximal aerobic capacity of patients with HFpEF.
- Hypothesis: HFpEF patients undergoing the different exercise interventions will have a similar peak VO2 response at the end of exercise training program (3-months) and at 1-year follow-up.
# Aim 2: To determine the effects of exercise training, comparing clinic versus home interventions, on chronic lowgrade inflammation, on endothelial dysfunction and repair, and on protein aggregates and infer the main molecular pathways altered in patients with HFpEF that are responsive to exercise.
- Hypothesis: HFpEF patients undergoing the different exercise interventions, with similar adherence, will have a
similar improvement in protein aggregates, inflammation, endothelial dysfunction and repair biomarkers.
# Aim 3: To compare individual disutility (inconvenience) perceived by HFpEF patients and respective quality of life (QoL) gains from participating in clinic-based versus home-based exercise program.
- Hypothesis: The ratio between perceived disutility and QoL gains will be favorable (lower ratio) in patients participating the home-based program than clinic-based.
# Aim 4: To compare the cost-effectiveness of a clinic-based versus home-based exercise training intervention in HFpEF outpatients.
- Hypothesis: The home-based exercise program will be more cost-effective than the clinic-based one.
The main purposes of this project were to determine : 1) the prevalence of CVD risk factors and metabolic risk factors and to characterize the global cardiovascular risk using the Heart Score; 2) the association of CVD and metabolic risk factors, and overall cardiovascular risk with markers of inflammation, daily physical activity, and cardiorespiratory fitness;
3) the weight and contribution of physical (in)activity and cardiorespiratory fitness to the cardiovascular risk inflammatory levels; 4) the effects of an educational and counseling intervention on physical activity, cardiorespiratory fitness, CVD risk factors, markers of inflammation, and global cardiovascular risk.
To accomplish these purposes, we conducted a cross-sectional study (purposes #1 to #3) followed by a single-centre, prospective, randomized controlled study (purpose #4). For the cross-sectional study, 532 subjects were randomly recruited from the universe of 8,000 subjects registered at the Family Health Unit. The subjects underwent the following assessments: anthropometrics, resting heart rate and blood pressure, daily physical activity, dietary intake, cardiorespiratory fitness, heart score, lipid profile and metabolic parameters, levels of C-reactive protein, interleukin-6, tumor necrosis factor alpha, phospholipase A2, adiponectin, and leptin.
From those 532, 150 were randomly enrolled in the RCT. The subjects in the intervention groups participated in home-based program for 4 months. The control group will receive usual care.
The knowledge and experience with the home-based intervention is going to be helpful in the present project. We observed that sedentary time, but not moderate-to-vigorous physical activity, is associated with cfPWV independently of age and metabolic risk factors. The home-based intervention improved several of the parameters in assessment in the present study, namely inflammatory markers and cardiorespiratory fitness, which raise good perspectives for our project. |
