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Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
control
moderate-intensity group
low-intensity group
Sponsored by
Naomi Kondo Nakagawa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring muscle training, walking test, chronic heart failure, functional capacity

Eligibility Criteria

18 Years - 70 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 40%.

Exclusion Criteria:

  • uncontrolled arrhythmia
  • pulmonary edema or pulmonary congestion in the last 30 days
  • peripheral oxygen saturation bellow 92% in resting condition
  • respiratory infection in the previous 30 days to the enrollment into the study
  • cognitive, neurological or orthopedic limitations

Sites / Locations

  • Instituto Dante Pazzanese de Cardiologia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Active Comparator

Arm Label

Control group

moderate-intensity group

low-intensity group

Arm Description

patients awaiting for evaluation to cardiac rehabilitation or transplantation

Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test).

Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each).

Outcomes

Primary Outcome Measures

Change in respiratory muscle strength (in centimeters of water)
Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).

Secondary Outcome Measures

walking distance
To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)

Full Information

First Posted
September 29, 2014
Last Updated
December 4, 2015
Sponsor
Naomi Kondo Nakagawa
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto Dante Pazzanese de Cardiologia
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1. Study Identification

Unique Protocol Identification Number
NCT02263482
Brief Title
Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure
Official Title
Inspiratory Muscle and Peripheral Muscle Combined Training Effects on the Respiratory and Functional Capacity and Quality of Life in Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Naomi Kondo Nakagawa
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto Dante Pazzanese de Cardiologia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Heart failure is a clinical syndrome that is the common end of several cardiac diseases with symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve respiratory and general functional capacity of these patients, there are strategies that can be used such as inspiratory muscle training and peripheral muscle training (dynamic resistance training).
Detailed Description
After agreement with the written informed consent, 35 subjects with severe heart failure were included in this study. They were randomized in three groups: controls, low-intensity and moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention. Cardiac events were registered following two years from baseline. The present study aimed to assess the effects of a combined program of inspiratory and peripheral muscle training on respiratory and general functional capacity and quality of life in patients with chronic heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
muscle training, walking test, chronic heart failure, functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
patients awaiting for evaluation to cardiac rehabilitation or transplantation
Arm Title
moderate-intensity group
Arm Type
Experimental
Arm Description
Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test).
Arm Title
low-intensity group
Arm Type
Active Comparator
Arm Description
Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each).
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation
Intervention Type
Other
Intervention Name(s)
moderate-intensity group
Intervention Description
Patients will be submitted to a 8-weeks training program with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).
Intervention Type
Other
Intervention Name(s)
low-intensity group
Intervention Description
Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)
Primary Outcome Measure Information:
Title
Change in respiratory muscle strength (in centimeters of water)
Description
Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil).
Time Frame
Before and after 8-weeks
Secondary Outcome Measure Information:
Title
walking distance
Description
To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines)
Time Frame
Before and after 8-weeks
Other Pre-specified Outcome Measures:
Title
Change in pulmonary function
Description
Pulmonary function will be assessed by spirometry.
Time Frame
Before and after 8-weeks
Title
Change in functional capacity
Description
1RM
Time Frame
Before and after 8-weeks
Title
Inflammation in the upper airway by cytokines in blood
Description
MMP2, myoglobin, p-selectin, MPO, NGAL, sVCAM, IL-2, IL-3, IL-4, IL-8,MIP1-alpha, 17, VEGF by Multiplex analysis. Inflammatory cells in nasal lavage will be also investigated.
Time Frame
Before and after 8-weeks
Title
Change in heart rate variability (HRV)
Description
HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland)
Time Frame
Before and after 8-weeks
Title
Prevalence of cardiac events and arrhythmia
Description
by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
Time Frame
Before and after 8-weeks
Title
Change in international Physical Activity Questionnaire (IPAQ)
Description
Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001).
Time Frame
Before and after 8-weeks
Title
Change in quality of life using Minnesota Questionnaire
Description
by Short Form-36 and by Minnesota Living with Heart Failure Questionnaire - Minnesota living with heart failure questionaire: contains 21 questions of physical, social, economic and emotional aspects. Each question ranges from zero to five points, with a total score of 105 points which is the maximum severity degree related to personal perception of quality of life.
Time Frame
Before and after 8-weeks
Title
Change in brain natriuretic peptide (BNP) analysis
Description
A blood sample of 5 ml will be collected in a tube and BNP measured
Time Frame
Before and after 8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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 40%. Exclusion Criteria: uncontrolled arrhythmia pulmonary edema or pulmonary congestion in the last 30 days peripheral oxygen saturation bellow 92% in resting condition respiratory infection in the previous 30 days to the enrollment into the study cognitive, neurological or orthopedic limitations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi K Nakagawa, PhD
Organizational Affiliation
USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil

12. IPD Sharing Statement

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Inspiratory Muscle and Peripheral Muscle Training in Chronic Heart Failure

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