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

The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Other: High-intensity IMT + Aerobic/resistance exercise; Other: Low-intensity IMT + Aerobic/resistance exercise; Other: Sham IMT + Aerobic/resistance exercise

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mansueto Gomes-Neto, PhD; Phone Number: 55-71-999188277; Email: mansueto.neto@ufba.br

Study Locations

• Brazil
  • BA
    • Salvador, BA, Brazil, 40100-110
      • Recruiting
      • Mansueto Gomes Neto
      • Contact: Mansueto G Neto, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength	Maximal respiratory pressures	10 weeks
Disability	The World Health Organization Disability Assessment Schedule (WHODAS 2.0)	10 weeks

Collaborators and Investigators

• Sponsor: Federal University of Bahia
• Investigators: Principal Investigator: Mansueto Gomes-Neto, PhD, Federal University of Bahia

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (ACTUAL): August 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Heart Failure; Rehabilitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: FUBahia HIIT IMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No