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The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome

Primary Purpose

Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training (IMT)
Sham IMT
Sponsored by
University of Cruz Alta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring inspiratory muscle training, heart failure, obstructive sleep apnea

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heart failure patients with obstructive sleep apnea- hypopnea
  • Heart failure patients without sleep apnea
  • Left ventricle fraction ejection < 51 % for men and < 53% for woman
  • Must be clinically stable
  • New York Heart Association I, II and III
  • Without changes in medication for the last three months.

Exclusion Criteria:

  • Unstable angina
  • Atrial fibrillation
  • Acute myocardial infarction (<6 months)
  • Recent heart surgery (<6 months)
  • Chronic metabolic disease
  • Infectious disease
  • Anemia
  • Severe hypoxemia
  • Neuromuscular disease
  • Diabetes mellitus
  • Obesity
  • Use of continuous positive airway pressure
  • Smoking
  • Pulmonary disease (forced vital capacity <80% of predicted and / or forced expiratory volume in one second <70% predicted).

Sites / Locations

  • University of Cruz AltaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory muscle training (IMT)

Sham IMT

Arm Description

Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.

Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center.

Outcomes

Primary Outcome Measures

Apnea hypopnea index
measured by portable polysomnography [in events/hour]

Secondary Outcome Measures

sleepiness
measured by Epworth Sleepiness Scale [in score]
sleep quality
assessed by the Pittsburgh sleep quality index [in score]
cognitive function
measured by the mini-mental state [in points]
motor task
assessed by the execution of a sequence of digital movements [in time required and number of execution errors]
executive function measured by Trail Making Test
measured by Trail Making Test. In Part A, participants are asked to link numbered points randomly distributed on a sheet of paper in ascending order according to numbers. In Part B, the participants are asked to link numbers and letters alternately [in time of test performance, counts the number of errors, and calculates the difference in times: B-A.].
quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
peak oxygen consumption
It will be assessed using of treadmill stress test with Bruce protocol. The peak oxygen consumption will be estimated according to the method established by the American College Sports Medicine [in mL.kg-1.min-1]
chemoreflex sensitivity
peripheral chemoreflex will be assessed by transient hypoxia [in L.min-1.mmHg] and central chemoreflex by hypercapnic hyperoxic in [L. min-1. %SatO2]
vagal modulation measured by heart rate monitoring in the time domain (spectral analysis)
measured by heart rate monitoring in the time domain by spectral analysis [in normalized units]

Full Information

First Posted
May 31, 2016
Last Updated
August 7, 2016
Sponsor
University of Cruz Alta
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02794935
Brief Title
The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
Official Title
The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cruz Alta
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea syndrome.
Detailed Description
Patients with heart failure will be selected through the Outpatient of the Rio Grande do Sul, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle endurance, portable polysomnography, sleepiness, sleep quality, cognitive function (mini-mental state examination), motor task (execution of a sequence of digital movements), executive function, quality of life (SF-36), maximum exercise testing, chemoreflex sensitivity (peripheral chemoreflex by transient hypoxia and central chemoreflex by hypercapnic hyperoxia) and vagal modulation of heart rate (spectral analysis) before the start of the training protocol. Patients will be randomized to inspiratory muscle training or control group. Inspiratory muscle training will be performed for 30 minutes a day, 7 days a week, for 12 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (30% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A group study with 15 heart failure patients without obstructive sleep apnea syndrome will be included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
inspiratory muscle training, heart failure, obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training (IMT)
Arm Type
Experimental
Arm Description
Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
Arm Title
Sham IMT
Arm Type
Placebo Comparator
Arm Description
Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training (IMT)
Intervention Description
Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
Intervention Type
Other
Intervention Name(s)
Sham IMT
Intervention Description
Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center
Primary Outcome Measure Information:
Title
Apnea hypopnea index
Description
measured by portable polysomnography [in events/hour]
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
sleepiness
Description
measured by Epworth Sleepiness Scale [in score]
Time Frame
12 weeks
Title
sleep quality
Description
assessed by the Pittsburgh sleep quality index [in score]
Time Frame
12 weeks
Title
cognitive function
Description
measured by the mini-mental state [in points]
Time Frame
12 weeks
Title
motor task
Description
assessed by the execution of a sequence of digital movements [in time required and number of execution errors]
Time Frame
12 weeks
Title
executive function measured by Trail Making Test
Description
measured by Trail Making Test. In Part A, participants are asked to link numbered points randomly distributed on a sheet of paper in ascending order according to numbers. In Part B, the participants are asked to link numbers and letters alternately [in time of test performance, counts the number of errors, and calculates the difference in times: B-A.].
Time Frame
12 weeks
Title
quality of life assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
Description
assessed by the The Medical Outcomes Study - Short-form 36 (SF-36)
Time Frame
12 weeks
Title
peak oxygen consumption
Description
It will be assessed using of treadmill stress test with Bruce protocol. The peak oxygen consumption will be estimated according to the method established by the American College Sports Medicine [in mL.kg-1.min-1]
Time Frame
12 weeks
Title
chemoreflex sensitivity
Description
peripheral chemoreflex will be assessed by transient hypoxia [in L.min-1.mmHg] and central chemoreflex by hypercapnic hyperoxic in [L. min-1. %SatO2]
Time Frame
12 weeks
Title
vagal modulation measured by heart rate monitoring in the time domain (spectral analysis)
Description
measured by heart rate monitoring in the time domain by spectral analysis [in normalized units]
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart failure patients with obstructive sleep apnea- hypopnea Heart failure patients without sleep apnea Left ventricle fraction ejection < 51 % for men and < 53% for woman Must be clinically stable New York Heart Association I, II and III Without changes in medication for the last three months. Exclusion Criteria: Unstable angina Atrial fibrillation Acute myocardial infarction (<6 months) Recent heart surgery (<6 months) Chronic metabolic disease Infectious disease Anemia Severe hypoxemia Neuromuscular disease Diabetes mellitus Obesity Use of continuous positive airway pressure Smoking Pulmonary disease (forced vital capacity <80% of predicted and / or forced expiratory volume in one second <70% predicted).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine C Callegaro, PhD
Phone
55 55 9914-6712
Email
ccallegaro@unicruz.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine C Callegaro, PhD
Organizational Affiliation
University of Cruz Alta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cruz Alta
City
Cruz Alta
State/Province
Rio Grande do Sul
ZIP/Postal Code
9800050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine C Callegaro
Email
ccallegaro@unicruz.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The volunteers will receive the results of the evaluations pre and post-intervention by the of the study.

Learn more about this trial

The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome

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