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

NCT03615157 | Unknown

• 1 other identifier: CEP 411/14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Heart Failure

Keywords

Home-based exercise; Functional capacity; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Incidence of cardiac events and arrhythmia

  Baseline and after 12 weeks of exercise programs

• Changes in distance from the six minute walk test (6MW, m)

  Baseline and after 4, 8 and 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

Study Arms (2)

Home-based exercise rehabilitation

EXPERIMENTAL

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

Supervised exercise rehabilitation

ACTIVE COMPARATOR

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

Interventions

Exercise rehabilitation 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.

Also known as: Aerobic and resistance training

Home-based exercise rehabilitation; Supervised exercise rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Instituto Dante Pazzanese de Cardiologia: collaborator
• InCor Heart Institute: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

School of Medicine, University of Sao Paulo

São Paulo, São Paulo, 01246903, Brazil

RECRUITING

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 34133657 DERIVED

MeSH Terms

Interventions

Exercise Therapy; Resistance Training

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Naomi K Nakagawa, PhD

CONTACT

+551130618529; naomi.kondo@fm.usp.br

Geisa N Andrade

CONTACT

+5511993038655; geisandrade@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medical School of Sao Paulo University

Model Details: The participants will be randomized in two groups: Home-based and Supervised exercise groups

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: January 15, 2018
• Primary Completion: December 15, 2018
• Study Completion: February 15, 2019
• Last Updated: August 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: As soon as we have half data, we will make that available
• Access Criteria: For researchers

Locations

BR (2)