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

University of Sao Paulo

Status: Unknown

Conditions: Chronic Heart Failure

Treatments: Other: Exercise rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03615157

CEP 411/14

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Home-based exercise rehabilitation

Experimental group

Description:

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)

Treatment:

Other: Exercise rehabilitation

Supervised exercise rehabilitation

Active Comparator group

Description:

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)

Treatment:

Other: Exercise rehabilitation