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NCT07672041Not yet recruiting

Inspiratory Muscle Training for People With Heart Failure

Efficacy of an Inspiratory Muscle Training Protocol With Resistive Airflow Loading on Exercise Capacity, Respiratory Muscle Strength and Quality of Life in Individuals With Heart Failure: a Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 26 Jun 2026

Brief summary (registry, in English)

Heart failure is frequently associated with inspiratory muscle weakness, which contributes to dyspnea, reduced exercise capacity, impaired quality of life, and adverse cardiovascular outcomes. Although inspiratory muscle training (IMT) is a recommended adjunct to cardiovascular rehabilitation, the optimal training modality remains uncertain, particularly among patients with reduced and preserved ejection fraction. This randomized controlled trial will evaluate the efficacy of a novel inspiratory muscle training protocol using tapered flow resistive loading (TFRL) compared with conventional threshold loading (TL) and usual care. A total of 108 clinically stable patients with heart failure (NYHA class II-III) will be enrolled. Participants will be stratified according to heart failure phenotype (reduced or preserved ejection fraction) and allocated to one of three groups: TFRL, TL, or control. Both training interventions will be performed for 8 weeks in combination with supervised exercise-based cardiac rehabilitation. Primary and secondary outcomes will include inspiratory muscle strength and endurance, exercise capacity, pulmonary function, dyspnea, skeletal muscle oxygenation, autonomic balance, arterial stiffness, and health-related quality of life. The study is powered to detect moderate between-group differences and interaction effects with 80% statistical power and a two-sided alpha level of 0.05. Changes over time and between groups will be analyzed using analysis of covariance (ANCOVA), adjusting for baseline inspiratory muscle strength. The trial aims to determine whether TFRL provides superior clinical and physiological benefits compared with conventional inspiratory muscle training and whether treatment responses differ according to heart failure phenotype.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
108 (estimated)
First submitted
22 Jun 2026
Start date
Jun 2026
Primary completion date
May 2028
Lead sponsor
Universidad Nacional Andres Bello
NCT number
NCT07672041

What you commit to

  • Study type: Interventional
  • Planned participants: 108
  • From Jun 2026 to the primary completion date, May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with other concomitant cardiac or neurological disease.

Other illness

  • Participants with unstable angina, acute myocardial infarction, and/or heart surgery within the past three months.
  • Cardiac acute decompensation.

Other

  • Participants unable to perform a valid baseline cardiopulmonary exercise test.
  • Participants with difficulties in maintaining a proper mouth seal or unable to avoid air leakage during pulmonary function testing.
  • Participants in other non-pharmacological study will be also excluded.
  • Current smokers.

Who the study is looking for

  • History of symptomatic heart failure (NYHA functional class I and III).
  • Participants able to understand and respond to the instructions given in the study
  • Participants with stable disease at the moment of inclusion in this study.
  • Unaltered dose and type of medication up to three months before the start of the study

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Salud Sports Medicina Deportiva
Coordinator of this site? Confirm its status
Viña del MarChileUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.