Clinical trial NCT03615157: Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients
Official title: Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Home-based exercise
Functional capacity
Chronic Heart Failure
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto Dante Pazzanese de Cardiologia
name: InCor Heart Institute
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomized in two groups: Home-based and Supervised exercise groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in peak oxygen uptake (ml/kg/min)
timeFrame: Baseline and after 12 weeks of exercise programs
Secondary outcomes:
measure: Incidence of cardiac events and arrhythmia
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in distance from the six minute walk test (6MW, m)
timeFrame: Baseline and after 4, 8 and 12 weeks of exercise programs
measure: Changes in respiratory muscle strength (cmH2O)
timeFrame: Baseline and after 4, 8 and 12 weeks of exercise programs
measure: Changes in peripheral muscle strength (N) - Quadriceps mm
timeFrame: Baseline and after 4, 8 and 12 weeks of exercise program
measure: Changes in peripheral muscle strength (kgf) - Hand grip
timeFrame: Baseline and after 4, 8 and 12 weeks of exercise programs
measure: Changes in daily physical activity and sedentary lifestyle
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in quality of life using SF-36
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in quality of life using MLHF
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in brain natriuretic peptide (BNP, pg/mL)
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in heart rate variability (HRV)
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in sleep quality
timeFrame: Baseline and after 12 weeks of exercise programs
measure: Changes in daytime sleepiness
timeFrame: Baseline and after 12 weeks of exercise programs
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Medicine, University of Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
References:
citation: Andrade GN, Umeda IIK, Fuchs ARCN, Mastrocola LE, Rossi-Neto JM, Moreira DAR, Oliveira PA, Andre CDS, Cahalin LP, Nakagawa NK. Home-based training program in patients with chronic heart failure and reduced ejection fraction: a randomized pilot study. Clinics (Sao Paulo). 2021 Jun 11;76:e2550. doi: 10.6061/clinics/2021/e2550. eCollection 2021.