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

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT03247361
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07
• Primary Completion: 2019-08-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life: MLHFQ	10 weeks	Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)
Aerobic Capacity	10 weeks	Six-minute walk test

Secondary Outcome Measures

Name	Time	Method
Disability	10 weeks	The World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Respiratory muscle strength	10 weeks	Maximal respiratory pressures

Trial Locations

Locations (1)

Mansueto Gomes Neto; 🇧🇷 Salvador, BA, Brazil