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

Primary Purpose

Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise rehabilitation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Home-based exercise, Functional capacity, Chronic Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Medicine, University of Sao PauloRecruiting
  • Instituto Dante Pazzanese de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-based exercise rehabilitation

Supervised exercise rehabilitation

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Changes in peak oxygen uptake (ml/kg/min)
Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks.

Secondary Outcome Measures

Incidence of cardiac events and arrhythmia
By a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
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
Changes in respiratory muscle strength (cmH2O)
Inspiratory and expiratory muscle strength will be assessed using an analogic pressure transducer
Changes in peripheral muscle strength (N) - Quadriceps mm
Quadriceps strength will be assessed by MicroFet 2 dynamometer (HogganHealth, USA)
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)
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
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)
Changes in quality of life using SF-36
Quality of life will be assessed by the Short Form-36 Questionnaire
Changes in quality of life using MLHF
Quality of life will be assessed by the Minnesota Living with Heart Failure Questionnaire
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
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
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.
Changes in daytime sleepiness
Daytime sleepiness will be assessed by the Epworth Sleepiness Scale

Full Information

First Posted
July 30, 2018
Last Updated
August 2, 2018
Sponsor
University of Sao Paulo
Collaborators
Instituto Dante Pazzanese de Cardiologia, InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03615157
Brief Title
Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients
Official Title
Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Anticipated)
Study Completion Date
February 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Instituto Dante Pazzanese de Cardiologia, InCor Heart Institute, Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Home-based exercise, Functional capacity, Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants will be randomized in two groups: Home-based and Supervised exercise groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based exercise rehabilitation
Arm Type
Experimental
Arm Description
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)
Arm Title
Supervised exercise rehabilitation
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Exercise rehabilitation
Other Intervention Name(s)
Aerobic and resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in peak oxygen uptake (ml/kg/min)
Description
Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks.
Time Frame
Baseline and after 12 weeks of exercise programs
Secondary Outcome Measure Information:
Title
Incidence of cardiac events and arrhythmia
Description
By a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in distance from the six minute walk test (6MW, m)
Description
Patients will be submitted to the 6MW accordingly to the American Thoracic guidelines to assess functional capacity using the six minute walk test
Time Frame
Baseline and after 4, 8 and 12 weeks of exercise programs
Title
Changes in respiratory muscle strength (cmH2O)
Description
Inspiratory and expiratory muscle strength will be assessed using an analogic pressure transducer
Time Frame
Baseline and after 4, 8 and 12 weeks of exercise programs
Title
Changes in peripheral muscle strength (N) - Quadriceps mm
Description
Quadriceps strength will be assessed by MicroFet 2 dynamometer (HogganHealth, USA)
Time Frame
Baseline and after 4, 8 and 12 weeks of exercise program
Title
Changes in peripheral muscle strength (kgf) - Hand grip
Description
Hand grip strength will be assessed by Jamar dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440)
Time Frame
Baseline and after 4, 8 and 12 weeks of exercise programs
Title
Changes in daily physical activity and sedentary lifestyle
Description
Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on waist during 9 days to asses daily physical activity and sedentary lifestyle
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in International Physical Activity Questionnaire (IPAQ)
Description
Patients will be classified as sedentary, irregularly active, active or very active according to Matsudo's Classification (2001)
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in quality of life using SF-36
Description
Quality of life will be assessed by the Short Form-36 Questionnaire
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in quality of life using MLHF
Description
Quality of life will be assessed by the Minnesota Living with Heart Failure Questionnaire
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in brain natriuretic peptide (BNP, pg/mL)
Description
A blood sample of 5 ml will be collected in a tube and BNP will be measured
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in heart rate variability (HRV)
Description
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
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in sleep quality
Description
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.
Time Frame
Baseline and after 12 weeks of exercise programs
Title
Changes in daytime sleepiness
Description
Daytime sleepiness will be assessed by the Epworth Sleepiness Scale
Time Frame
Baseline and after 12 weeks of exercise programs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi K Nakagawa, PhD
Phone
+551130618529
Email
naomi.kondo@fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Geisa N Andrade
Phone
+5511993038655
Email
geisandrade@usp.br
Facility Information:
Facility Name
School of Medicine, University of Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NAOMI KONDO NAKAGAWA N KONDO
Phone
11999450626
Email
naomi.kondo@fm.usp.br
First Name & Middle Initial & Last Name & Degree
Geisa N Andrade, BSc
First Name & Middle Initial & Last Name & Degree
Patricia A Oliveira, MD
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iracema IK Umeda, PhD
Phone
+551150856304
Email
iikumeda@usp.br
First Name & Middle Initial & Last Name & Degree
Geisa N Andrade
Phone
+5511993038655
Email
geisandrade@usp.br
First Name & Middle Initial & Last Name & Degree
Angela CN Fuchs, PhD
First Name & Middle Initial & Last Name & Degree
Dalmo AR Moreira, PhD
First Name & Middle Initial & Last Name & Degree
Joao M Rossi-Neto, PhD
First Name & Middle Initial & Last Name & Degree
Iracema IK Umeda, PhD
First Name & Middle Initial & Last Name & Degree
Luiz E Mastrocolla, PhD
First Name & Middle Initial & Last Name & Degree
Geisa N Andrade, BSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34133657
Citation
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.
Results Reference
derived

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

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