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High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High-intensity IMT + Aerobic/resistance exercise
Low-intensity IMT + Aerobic/resistance exercise
Sham IMT + Aerobic/resistance exercise
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure; Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The target population consists of adults patients aged ≥ 18 years with heart failure and New York Heart Association (NYHA) class I-III.

Exclusion Criteria:

  • Unstable angina;
  • coronary revascularization;
  • Decompensated heart failure functional class IV (NYHA);
  • Recent transplant or hospitalization (6 months <);
  • Chronic Obstructive Pulmonary Disease;
  • Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases;
  • Recent myocardial infarction or cardiac surgery (less than 6 months);
  • Atrial Fibrillation.

Sites / Locations

  • Mansueto Gomes NetoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

High-intensity IMT

Low-intensity IMT

Aerobic/resistance exercise

Arm Description

High-intensity IMT + Aerobic/resistance exercise IMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min. Exercise: see group Combined aerobic/resistance exercise

Low-intensity IMT + Aerobic/resistance exercise IMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes. Exercise: see group Combined aerobic/resistance exercise

Sham IMT + Aerobic/resistance exercise Aerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR.

Outcomes

Primary Outcome Measures

Aerobic Capacity
Six-minute walk test
Health-Related Quality of Life: MLHFQ
Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)

Secondary Outcome Measures

Respiratory muscle strength
Maximal respiratory pressures
Disability
The World Health Organization Disability Assessment Schedule (WHODAS 2.0)

Full Information

First Posted
August 9, 2017
Last Updated
November 5, 2018
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT03247361
Brief Title
High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure
Official Title
The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

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
It is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with HF. Interestingly, not only peripheral muscles are impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of inspiratory muscles have been associated with low quality of life and poor prognosis, which make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular rehabilitation.The specifications of the loads to be imposed during IMT is the main factor determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory workload during exercise. Thus, purpose of this report was to perform a randomized clinical trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic and resistance Exercise in patients with heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure; Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity IMT
Arm Type
Experimental
Arm Description
High-intensity IMT + Aerobic/resistance exercise IMT: Training loads will be adjusted weekly to the maximal inspiratory pressure (MIP). In the first 2 weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 30 sec, with 30-sec of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 10 min and 30 sec. From the third week the protocol will be of 2 min warm-up with intensity 30% of MIP. The training will have 7 peaks of intensity with 70% of MIP for 60 sec, with 60-second of passive rest between the peaks, finishing the training with 20% of MIP for 2 min, totaling 17 min. Exercise: see group Combined aerobic/resistance exercise
Arm Title
Low-intensity IMT
Arm Type
Active Comparator
Arm Description
Low-intensity IMT + Aerobic/resistance exercise IMT:Training loads will be also adjusted weekly to the maximal inspiratory pressure (MIP). In the first two weeks as adaptation, the protocol will be of 2 minutes warm-up with intensity 20% of MIP. The training will be held with 3 sets of 15 repetitions, with 40% of MIP, finishing the training with 20% of MIP for 2 minutes. From the third week the protocol will be of 2 minutes warm-up with intensity 30% of MIP. The training will be held with 3 sets of 15 repetitions, with 60% of MIP, finishing the training with 30% of MIP for 2 minutes. Exercise: see group Combined aerobic/resistance exercise
Arm Title
Aerobic/resistance exercise
Arm Type
Sham Comparator
Arm Description
Sham IMT + Aerobic/resistance exercise Aerobic session will consist of a 4-min of warm-up, 20 minutes of exercise, and 4 min of cool-down. Intensity will set by the formula: Training HR = (maximum HR - resting HR) × intensity % + resting HR. Patients will exercise using 30 seconds, high-intensity work phases 0.7% followed by 1-minute recovery bouts 0.5%. Resistance exercise will consist of dynamic lower and upper limb exercise. Upper limb exercises will include 3 sets of exercises for each muscle group performed with 10 repetitions each. Lower limb exercises will include 3 sets of exercises for each muscle group performed with 12 repetitions each. Resistance exercises will be performed at 12-MR.
Intervention Type
Other
Intervention Name(s)
High-intensity IMT + Aerobic/resistance exercise
Intervention Description
High-intensity IMT
Intervention Type
Other
Intervention Name(s)
Low-intensity IMT + Aerobic/resistance exercise
Intervention Description
Low-intensity IMT
Intervention Type
Other
Intervention Name(s)
Sham IMT + Aerobic/resistance exercise
Intervention Description
Aerobic and resistance exercise
Primary Outcome Measure Information:
Title
Aerobic Capacity
Description
Six-minute walk test
Time Frame
10 weeks
Title
Health-Related Quality of Life: MLHFQ
Description
Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Maximal respiratory pressures
Time Frame
10 weeks
Title
Disability
Description
The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The target population consists of adults patients aged ≥ 18 years with heart failure and New York Heart Association (NYHA) class I-III. Exclusion Criteria: Unstable angina; coronary revascularization; Decompensated heart failure functional class IV (NYHA); Recent transplant or hospitalization (6 months <); Chronic Obstructive Pulmonary Disease; Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases; Recent myocardial infarction or cardiac surgery (less than 6 months); Atrial Fibrillation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mansueto Gomes-Neto, PhD
Phone
55-71-999188277
Email
mansueto.neto@ufba.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansueto Gomes-Neto, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansueto Gomes Neto
City
Salvador
State/Province
BA
ZIP/Postal Code
40100-110
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansueto G Neto, PhD

12. IPD Sharing Statement

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High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure

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