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

NCT ID: NCT03247361

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-08-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

High-intensity IMT + Aerobic/resistance exercise

Intervention Type: OTHER

High-intensity IMT

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

Group Type: ACTIVE_COMPARATOR

Low-intensity IMT + Aerobic/resistance exercise

Intervention Type: OTHER

Low-intensity IMT

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.

Group Type: SHAM_COMPARATOR

Sham IMT + Aerobic/resistance exercise

Intervention Type: OTHER

Aerobic and resistance exercise

Interventions

High-intensity IMT + Aerobic/resistance exercise

High-intensity IMT

Intervention Type: OTHER

Low-intensity IMT + Aerobic/resistance exercise

Low-intensity IMT

Intervention Type: OTHER

Sham IMT + Aerobic/resistance exercise

Aerobic and resistance exercise

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: lead

Responsible Party

Mansueto Gomes Neto

Principal researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mansueto Gomes-Neto, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Locations

Mansueto Gomes Neto

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Mansueto Gomes-Neto, PhD

Role: CONTACT

mansueto.neto@ufba.br

55-71-999188277

Facility Contacts

Mansueto G Neto, PhD

Role: primary

Other Identifiers

FUBahia HIIT IMT

Identifier Type: -

Identifier Source: org_study_id