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

NCT03247361 | Unknown

• 1 other identifier: FUBahia HIIT IMT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Heart Failure; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Aerobic Capacity

  Six-minute walk test

  10 weeks

• Health-Related Quality of Life: MLHFQ

  Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)

  10 weeks

Secondary Outcomes (2)

• Respiratory muscle strength

  10 weeks

• Disability

  10 weeks

Study Arms (3)

High-intensity IMT

EXPERIMENTAL

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

Low-intensity IMT

ACTIVE COMPARATOR

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

Aerobic/resistance exercise

SHAM COMPARATOR

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

Interventions

High-intensity IMT + Aerobic/resistance exercise OTHER

High-intensity IMT

High-intensity IMT

Low-intensity IMT + Aerobic/resistance exercise OTHER

Low-intensity IMT

Low-intensity IMT

Sham IMT + Aerobic/resistance exercise OTHER

Aerobic and resistance exercise

Aerobic/resistance exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Mansueto Gomes Neto

Salvador, Estado de Bahia, 40100-110, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mansueto Gomes-Neto, PhD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mansueto Gomes-Neto, PhD

CONTACT

55-71-999188277; mansueto.neto@ufba.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal researcher

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 11, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

BR (1)