Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients

Study Overview
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Brief Summary
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Heart failure (HF) is a multisystemic disease leading to exercise intolerance and fatigue. Supervised physical training improves functional capacity, quality of life and reduces hospital admissions in HF patients. In this way, home physical training may be a good alternative to patients who, for any reason, cannot perform supervised training. Objective: To asses the effects of a home-based training program on functional capacity, sedentary lifestyle and quality of life of patients with chronic HF compared to supervised training.

Detailed Description
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After agreement with the written informed consent, subjects with heart failure (left ventricle ejection fraction bellow or equal 40%) will be included in this study. They will be randomized in two groups: Home-based and Supervised exercise groups. The two groups will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. All volunteers will be assessed at baseline and after twelve weeks of intervention. Peripheric and respiratory muscle strength as well the 6MW analyses were assessed also at 4 and 8 weeks after baseline.

Official Title
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Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Other: Exercise rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic heart failure (functional class from NYHA II and III), Left ventricle ejection fraction bellow or equal to 40% Clinical stability during the last three months Medical release for physical training after cardiopulmonary test Exclusion Criteria: Uncontrolled arrhythmia Pulmonary artery systolic pressure > 35 mmHg by the echo doppler cardiogram, Peripheral oxygen saturation < 92% in resting condition Respiratory infection in the previous 30 days to the enrollment into the study Cognitive, neurological or orthopedic limitations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants will be randomized in two groups: Home-based and Supervised exercise groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based exercise rehabilitation<br>Patients will be submitted to a 12-weeks training program, with walking at 60-70% of heart rate reserve monitored by a heart rate monitor (30 minutes/session for 5 days/week) and peripheral muscle training including upper and lower limbs (50% of the 1-maximum repetition test) | Other: Exercise rehabilitation<br>* Patients will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. They will be randomized in two groups: Home-based and Supervised.<br>* Other names: Aerobic and resistance training;|
| Active Comparator: Supervised exercise rehabilitation<br>Patients will be submitted to a 12-weeks training program, with sessions (3 days/week) supervised by a physiotherapist, including cycling at 60-70% of heart rate reserve and peripheral muscle training of upper and lower limbs (50% of the 1-maximum repetition test) | Other: Exercise rehabilitation<br>* Patients will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. They will be randomized in two groups: Home-based and Supervised.<br>* Other names: Aerobic and resistance training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in peak oxygen uptake (ml/kg/min) | Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks. | Baseline and after 12 weeks of exercise programs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiac events and arrhythmia | By a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs | Baseline and after 12 weeks of exercise programs | 
| Changes in distance from the six minute walk test (6MW, m) | Patients will be submitted to the 6MW accordingly to the American Thoracic guidelines to assess functional capacity using the six minute walk test | Baseline and after 4, 8 and 12 weeks of exercise programs | 
| Changes in respiratory muscle strength (cmH2O) | Inspiratory and expiratory muscle strength will be assessed using an analogic pressure transducer | Baseline and after 4, 8 and 12 weeks of exercise programs | 
| Changes in peripheral muscle strength (N) - Quadriceps mm | Quadriceps strength will be assessed by MicroFet 2 dynamometer (HogganHealth, USA) | Baseline and after 4, 8 and 12 weeks of exercise program | 
| Changes in peripheral muscle strength (kgf) - Hand grip | Hand grip strength will be assessed by Jamar dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440) | Baseline and after 4, 8 and 12 weeks of exercise programs | 
| Changes in daily physical activity and sedentary lifestyle | Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on waist during 9 days to asses daily physical activity and sedentary lifestyle | Baseline and after 12 weeks of exercise programs | 
| Changes in International Physical Activity Questionnaire (IPAQ) | Patients will be classified as sedentary, irregularly active, active or very active according to Matsudo's Classification (2001) | Baseline and after 12 weeks of exercise programs | 
| Changes in quality of life using SF-36 | Quality of life will be assessed by the Short Form-36 Questionnaire | Baseline and after 12 weeks of exercise programs | 
| Changes in quality of life using MLHF | Quality of life will be assessed by the Minnesota Living with Heart Failure Questionnaire | Baseline and after 12 weeks of exercise programs | 
| Changes in brain natriuretic peptide (BNP, pg/mL) | A blood sample of 5 ml will be collected in a tube and BNP will be measured | Baseline and after 12 weeks of exercise programs | 
| Changes in heart rate variability (HRV) | HRV will be analysed from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland) during the 6MW | Baseline and after 12 weeks of exercise programs | 
| Changes in sleep quality | Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on wrist for nine days to asses Sleep quality. Furthermore, the Pittsburgh Sleep Quality Index will be used to classify patients as good or poor sleepers. | Baseline and after 12 weeks of exercise programs | 
| Changes in daytime sleepiness | Daytime sleepiness will be assessed by the Epworth Sleepiness Scale | Baseline and after 12 weeks of exercise programs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home-based exercise, Functional capacity, Chronic Heart Failure