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

NCT ID: NCT03615157

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-02-15

Brief Summary

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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

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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.

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants will be randomized in two groups: Home-based and Supervised exercise groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Exercise rehabilitation

Intervention Type OTHER

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.

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)

Group Type ACTIVE_COMPARATOR

Exercise rehabilitation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Aerobic and resistance training

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role collaborator

InCor Heart Institute

OTHER

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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NAOMI KONDO NAKAGAWA NAOMI KONDO

Associate Professor of Medical School of Sao Paulo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Medicine, University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Naomi K Nakagawa, PhD

Role: CONTACT

+551130618529

Geisa N Andrade

Role: CONTACT

+5511993038655

Facility Contacts

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NAOMI KONDO NAKAGAWA N KONDO

Role: primary

11999450626

Iracema IK Umeda, PhD

Role: primary

+551150856304

Geisa N Andrade

Role: backup

+5511993038655

References

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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.

Reference Type DERIVED
PMID: 34133657 (View on PubMed)

Other Identifiers

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CEP 411/14

Identifier Type: -

Identifier Source: org_study_id

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