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

Not Applicable

• Conditions: Chronic Heart Failure

• Registration Number: NCT03615157
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-15
• Status Verified: 2018-07
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-08-02
• Last Update Submitted: 2018-08-02
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03
• Primary Completion: 2018-12-15
• Study Completion: 2019-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in peak oxygen uptake (ml/kg/min)	Baseline and after 12 weeks of exercise programs	Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

School of Medicine, University of Sao Paulo; 🇧🇷 São Paulo, SP, Brazil

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 Sao Paulo, Brazil