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

August 2, 2018 updated by: NAOMI KONDO NAKAGAWA NAOMI KONDO, University of Sao Paulo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04012-909
        • Recruiting
        • Instituto Dante Pazzanese de Cardiologia
        • Contact:
        • Sub-Investigator:
          • Geisa N Andrade, BSc
        • Contact:
        • Sub-Investigator:
          • Angela CN Fuchs, PhD
        • Sub-Investigator:
          • Dalmo AR Moreira, PhD
        • Sub-Investigator:
          • Joao M Rossi-Neto, PhD
        • Sub-Investigator:
          • Iracema IK Umeda, PhD
        • Sub-Investigator:
          • Luiz E Mastrocolla, PhD
    • SP
      • São Paulo, SP, Brazil, 01246903
        • Recruiting
        • School of Medicine, University of Sao Paulo
        • Contact:
        • Sub-Investigator:
          • Geisa N Andrade, BSc
        • Sub-Investigator:
          • Patricia A Oliveira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Home-based exercise rehabilitation
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)
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.
Other Names:
  • Aerobic and resistance training
ACTIVE_COMPARATOR: Supervised exercise rehabilitation
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)
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.
Other Names:
  • Aerobic and resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 12 weeks of exercise programs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardiac events and arrhythmia
Time Frame: Baseline and after 12 weeks of exercise programs
By a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
Baseline and after 12 weeks of exercise programs
Changes in distance from the six minute walk test (6MW, m)
Time Frame: 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
Baseline and after 4, 8 and 12 weeks of exercise programs
Changes in respiratory muscle strength (cmH2O)
Time Frame: Baseline and after 4, 8 and 12 weeks of exercise programs
Inspiratory and expiratory muscle strength will be assessed using an analogic pressure transducer
Baseline and after 4, 8 and 12 weeks of exercise programs
Changes in peripheral muscle strength (N) - Quadriceps mm
Time Frame: Baseline and after 4, 8 and 12 weeks of exercise program
Quadriceps strength will be assessed by MicroFet 2 dynamometer (HogganHealth, USA)
Baseline and after 4, 8 and 12 weeks of exercise program
Changes in peripheral muscle strength (kgf) - Hand grip
Time Frame: 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)
Baseline and after 4, 8 and 12 weeks of exercise programs
Changes in daily physical activity and sedentary lifestyle
Time Frame: 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
Baseline and after 12 weeks of exercise programs
Changes in International Physical Activity Questionnaire (IPAQ)
Time Frame: 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)
Baseline and after 12 weeks of exercise programs
Changes in quality of life using SF-36
Time Frame: Baseline and after 12 weeks of exercise programs
Quality of life will be assessed by the Short Form-36 Questionnaire
Baseline and after 12 weeks of exercise programs
Changes in quality of life using MLHF
Time Frame: Baseline and after 12 weeks of exercise programs
Quality of life will be assessed by the Minnesota Living with Heart Failure Questionnaire
Baseline and after 12 weeks of exercise programs
Changes in brain natriuretic peptide (BNP, pg/mL)
Time Frame: 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
Baseline and after 12 weeks of exercise programs
Changes in heart rate variability (HRV)
Time Frame: 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
Baseline and after 12 weeks of exercise programs
Changes in sleep quality
Time Frame: 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.
Baseline and after 12 weeks of exercise programs
Changes in daytime sleepiness
Time Frame: Baseline and after 12 weeks of exercise programs
Daytime sleepiness will be assessed by the Epworth Sleepiness Scale
Baseline and after 12 weeks of exercise programs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Instituto Dante Pazzanese de Cardiologia
InCor Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2018

Primary Completion (ANTICIPATED)

December 15, 2018

Study Completion (ANTICIPATED)

February 15, 2019

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (ACTUAL)

August 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 411/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

we will insert all individual data in a common website for research

IPD Sharing Time Frame

As soon as we have half data, we will make that available

IPD Sharing Access Criteria

For researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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