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

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ClinicalTrials.gov Identifier: NCT03247361
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Mansueto Gomes Neto, Federal University of Bahia

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: High-intensity IMT + Aerobic/resistance exercise Other: Low-intensity IMT + Aerobic/resistance exercise Other: Sham IMT + Aerobic/resistance exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-intensity IMT

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

Other: High-intensity IMT + Aerobic/resistance exercise
High-intensity IMT

Active Comparator: Low-intensity IMT

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

Other: Low-intensity IMT + Aerobic/resistance exercise
Low-intensity IMT

Sham Comparator: 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.

Other: Sham IMT + Aerobic/resistance exercise
Aerobic and resistance exercise




Primary Outcome Measures :
  1. Aerobic Capacity [ Time Frame: 10 weeks ]
    Six-minute walk test

  2. Health-Related Quality of Life: MLHFQ [ Time Frame: 10 weeks ]
    Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)


Secondary Outcome Measures :
  1. Respiratory muscle strength [ Time Frame: 10 weeks ]
    Maximal respiratory pressures

  2. Disability [ Time Frame: 10 weeks ]
    The World Health Organization Disability Assessment Schedule (WHODAS 2.0)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247361


Contacts
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Contact: Mansueto Gomes-Neto, PhD 55-71-999188277 mansueto.neto@ufba.br

Locations
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Brazil
Mansueto Gomes Neto Recruiting
Salvador, BA, Brazil, 40100-110
Contact: Mansueto G Neto, PhD         
Sponsors and Collaborators
Federal University of Bahia
Investigators
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Principal Investigator: Mansueto Gomes-Neto, PhD Federal University of Bahia

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Responsible Party: Mansueto Gomes Neto, Principal researcher, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT03247361     History of Changes
Other Study ID Numbers: FUBahia HIIT IMT
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mansueto Gomes Neto, Federal University of Bahia:
Heart Failure; Rehabilitation

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases