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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03247361
• Other study ID #: FUBahia HIIT IMT
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: November 2018
• Source: Federal University of Bahia
• Contact: Mansueto Gomes-Neto, PhD
• Phone: 55-71-999188277
• Email: mansueto.neto[@]ufba.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• High-intensity IMT + Aerobic/resistance exercise
High-intensity IMT
• Low-intensity IMT + Aerobic/resistance exercise
Low-intensity IMT
• Sham IMT + Aerobic/resistance exercise
Aerobic and resistance exercise

Locations

Country	Name	City	State
Brazil	Mansueto Gomes Neto	Salvador	BA

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic Capacity	Six-minute walk test	10 weeks
Primary	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	Respiratory muscle strength	Maximal respiratory pressures	10 weeks
Secondary	Disability	The World Health Organization Disability Assessment Schedule (WHODAS 2.0)	10 weeks