Back to resultsEXercise InTervention in Heart Failure (EXIT-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise Training Program
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Home-based exercise, Maximal oxygen consumption, Cost-effectiveness
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of HFrEF and HFpEF according to criteria of the European Society of Cardiology (2016)
- Clinical stability for ≥ 6 weeks
- Optimal medical treatment for ≥ 6 weeks
- Patients that are able to understand and follow the exercise prescription
- Written informed consent
Exclusion Criteria:
- Patients who have undertaken cardiac rehabilitation within the past 12 months
- Patients who have received an intracardiac defibrillator (ICD), Cardiac 3. Resynchronisation therapy (CRT) or combined CRT/ICD device implanted in the last 6 weeks
- Inability to exercise or conditions that may interfere with exercise intervention
- Signs of ischemia during cardiopulmonary exercise test
- Comorbidity that may influence one-year prognosis
- Symptomatic and/or exercise induced cardiac arrhythmia or conduction disturbances
- Currently pregnant or intend to become pregnant in the next year
- Expectation of receiving a cardiac transplant in the next 6 months
- Participation in another clinical trial
- Patients who are unable to understand the study information or unable to complete the outcome questionnaires
Sites / Locations
- Centro Hospitalar do Porto
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home-based exercise training
Clinical-based exercise training
Arm Description
The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at home
The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital
Outcomes
Primary Outcome Measures
Peak oxygen uptake (ml/kg/min)
Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 3 moths
Secondary Outcome Measures
6-min walk test (6MWT) distance
Changes in distance from the 6MWT.
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%.
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.
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.
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.
Physical activity (steps/day)
Physical activity will be assessed by a POLAR-M200 device with the numbers of daily steps.
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).
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.
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.
Hand grip strength
Hand grip strength will be assessed by Jamar dynamometer (kg)
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
Biomarkers (pg/ml)
NTproBNP and ST2 (pg/ml)
Biomarkers (mg/L)
hsCRP and Troponin (mg/L)
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
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.
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)
Physical fitness levels evaluation
Physical fitness levels will be evaluated by the Senior Fitness test
Full Information
NCT ID
NCT04334603
First Posted
January 22, 2020
Last Updated
February 22, 2023
Sponsor
Centro Hospitalar do Porto
Collaborators
Universidade do Porto, Aveiro University
1. Study Identification
Unique Protocol Identification Number
NCT04334603
Brief Title
EXercise InTervention in Heart Failure
Acronym
EXIT-HF
Official Title
EXercise InTervention in Heart Failure (EXIT-HF): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar do Porto
Collaborators
Universidade do Porto, Aveiro University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Home-based exercise, Maximal oxygen consumption, Cost-effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-based exercise training
Arm Type
Experimental
Arm Description
The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at home
Arm Title
Clinical-based exercise training
Arm Type
Active Comparator
Arm Description
The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital
Intervention Type
Other
Intervention Name(s)
Exercise Training Program
Intervention Description
The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital or at home.
Primary Outcome Measure Information:
Title
Peak oxygen uptake (ml/kg/min)
Description
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
Secondary Outcome Measure Information:
Title
6-min walk test (6MWT) distance
Description
Changes in distance from the 6MWT.
Time Frame
Change from baseline to 3 months, and to 12 months.
Title
Health status (EQ-5D-5L)
Description
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.
Title
Health-related quality of life (MLHFQ)
Description
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.
Title
Anxiety and Depression (HADS)
Description
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.
Title
Disutility
Description
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
Title
Physical activity (steps/day)
Description
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.
Title
Daily physical activity levels (min/day)
Description
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.
Title
Dyspnea
Description
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.
Title
Mediterranean diet
Description
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.
Title
Hand grip strength
Description
Hand grip strength will be assessed by Jamar dynamometer (kg)
Time Frame
Change from baseline to to 3 and to 12 months.
Title
Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase
Description
These markers will inform endothelial function, damage and repair
Time Frame
Change from baseline to 3 months
Title
Biomarkers (pg/ml)
Description
NTproBNP and ST2 (pg/ml)
Time Frame
Change from baseline to 3 months
Title
Biomarkers (mg/L)
Description
hsCRP and Troponin (mg/L)
Time Frame
Change from baseline to 3 months
Title
Concentration of plasma exosomes
Description
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
Title
Percentage of protein aggregates
Description
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
Title
Cost-effectiveness of home-based exercise Vs. clinical-base exercise
Description
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
Title
Physical fitness levels evaluation
Description
Physical fitness levels will be evaluated by the Senior Fitness test
Time Frame
Change from baseline to 3 and to 12 months.
Other Pre-specified Outcome Measures:
Title
Exploratory analyses of urine proteome
Description
Exploratory analyses in urine protein will be performed to identify novel biomarkers predictive of exercise training therapeutic response. Urine of 10 patients from each group will be analyzed using a proteomic approach combining one-dimensional gel electrophoresis with liquid chromatography-tandem mass spectrometry (GeLC-MS/MS). Generated proteomic data will be analyzed with bioinformatic tools to reveal possible biomarkers of interest, that will be further validated by immuno-approaches such as ELISA or immunoblot.
Time Frame
Change from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of HFrEF and HFpEF according to criteria of the European Society of Cardiology (2016)
Clinical stability for ≥ 6 weeks
Optimal medical treatment for ≥ 6 weeks
Patients that are able to understand and follow the exercise prescription
Written informed consent
Exclusion Criteria:
Patients who have undertaken cardiac rehabilitation within the past 12 months
Patients who have received an intracardiac defibrillator (ICD), Cardiac 3. Resynchronisation therapy (CRT) or combined CRT/ICD device implanted in the last 6 weeks
Inability to exercise or conditions that may interfere with exercise intervention
Signs of ischemia during cardiopulmonary exercise test
Comorbidity that may influence one-year prognosis
Symptomatic and/or exercise induced cardiac arrhythmia or conduction disturbances
Currently pregnant or intend to become pregnant in the next year
Expectation of receiving a cardiac transplant in the next 6 months
Participation in another clinical trial
Patients who are unable to understand the study information or unable to complete the outcome questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mário Santos, MD,PhD
Organizational Affiliation
Cardiology Service of Centro Hospitalar do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
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EXercise InTervention in Heart Failure
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