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Clinical Trials/NCT03615157
NCT03615157
Unknown
N/A

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

University of Sao Paulo2 sites in 1 country30 target enrollmentJanuary 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
University of Sao Paulo
Enrollment
30
Locations
2
Primary Endpoint
Changes in peak oxygen uptake (ml/kg/min)
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
February 15, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

NAOMI KONDO NAKAGAWA NAOMI KONDO

Associate Professor of Medical School of Sao Paulo University

University of Sao Paulo

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

Outcomes

Primary Outcomes

Changes in peak oxygen uptake (ml/kg/min)

Time Frame: Baseline and after 12 weeks of exercise programs

Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks.

Secondary Outcomes

  • Changes in distance from the six minute walk test (6MW, m)(Baseline and after 4, 8 and 12 weeks of exercise programs)
  • Incidence of cardiac events and arrhythmia(Baseline and after 12 weeks of exercise programs)
  • Changes in respiratory muscle strength (cmH2O)(Baseline and after 4, 8 and 12 weeks of exercise programs)
  • Changes in peripheral muscle strength (N) - Quadriceps mm(Baseline and after 4, 8 and 12 weeks of exercise program)
  • Changes in peripheral muscle strength (kgf) - Hand grip(Baseline and after 4, 8 and 12 weeks of exercise programs)
  • Changes in daily physical activity and sedentary lifestyle(Baseline and after 12 weeks of exercise programs)
  • Changes in International Physical Activity Questionnaire (IPAQ)(Baseline and after 12 weeks of exercise programs)
  • Changes in quality of life using SF-36(Baseline and after 12 weeks of exercise programs)
  • Changes in quality of life using MLHF(Baseline and after 12 weeks of exercise programs)
  • Changes in brain natriuretic peptide (BNP, pg/mL)(Baseline and after 12 weeks of exercise programs)
  • Changes in heart rate variability (HRV)(Baseline and after 12 weeks of exercise programs)
  • Changes in sleep quality(Baseline and after 12 weeks of exercise programs)
  • Changes in daytime sleepiness(Baseline and after 12 weeks of exercise programs)

Study Sites (2)

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