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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03247361

Enrollment

Registered

2017-08-11

Start date

2017-08-01

Completion date

2020-08-01

Last updated

2018-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure; Rehabilitation

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.

Interventions

OTHERHigh-intensity IMT + Aerobic/resistance exercise

High-intensity IMT

OTHERLow-intensity IMT + Aerobic/resistance exercise

Low-intensity IMT

OTHERSham IMT + Aerobic/resistance exercise

Aerobic and resistance exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Aerobic Capacity	10 weeks	Six-minute walk test
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)

Secondary

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

Countries

Brazil

Contacts

Primary ContactMansueto Gomes-Neto, PhD

mansueto.neto@ufba.br55-71-999188277

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026