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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615157
• Other study ID #: CEP 411/14
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2018
• Source: University of Sao Paulo
• Contact: Naomi K Nakagawa, PhD
• Phone: +551130618529
• Email: naomi.kondo[@]fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• Exercise rehabilitation
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.

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Brazil	School of Medicine, University of Sao Paulo	São Paulo	SP

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo, InCor Heart Institute, Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in daytime sleepiness	Daytime sleepiness will be assessed by the Epworth Sleepiness Scale	Baseline and after 12 weeks of exercise programs