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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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