Inspiratory Muscle Training for People With Heart Failure
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversidad Nacional Andres Bello
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Participants unable to perform a valid baseline cardiopulmonary exercise test.
Participants with unstable angina, acute myocardial infarction, and/or heart surgery within the past three months.
Participants with other concomitant cardiac or neurological disease.
Participants with difficulties in maintaining a proper mouth seal or unable to avoid air leakage during pulmonary function testing.
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratory muscle training with Tapered Resistive Load
Other interventionThe resistance pressure of the Tapered Resistive Load Device (POWER Breathe KH2) will be set at 60% of each participant's maximum inspiratory pressure measured at baseline. Re-evaluations of peak inspiratory pressure in both exercise groups will be carried out every 2 weeks to perform load progression. The training protocol has 6 levels depending on the rest period. The first level has 60 second rest periods and from the second level through the sixth level, the rest period will be reduced to 45, 30, 15, 10, and 5 seconds. All participants in all groups will perform 6 inspiratory efforts at each level. In total, each participant will perform 36 inspiratory efforts (6 levels x 6 efforts = 36 total efforts). Training sessions will be supervised and performed three times a week for 8 weeks.
Inspiratory muscle training with threshold load
Other interventionThe resistance pressure of the threshold device (POWER Breathe Plus Medic) will be set at 60% of each participant's maximum inspiratory pressure measured at baseline. Re-evaluations of peak inspiratory pressure in both exercise groups will be carried out every 2 weeks to perform load progression. The training protocol has 6 levels depending on the rest period. The first level has 60 second rest periods and from the second level through the sixth level, the rest period will be reduced to 45, 30, 15, 10, and 5 seconds. All participants in all groups will perform 6 inspiratory efforts at each level. In total, each participant will perform 36 inspiratory efforts (6 levels x 6 efforts = 36 total efforts). Training sessions will be supervised and performed three times a week for 8 weeks.
Concurrent Exercise Training
Other interventionThe concurrent training program will include aerobic and resistance exercise. Aerobic training will begin after a 5-minute warm-up at low to moderate intensity. This will be followed by 40 minutes of aerobic exercise at the anaerobic threshold (AT) power (PO) obtained from a cardiopulmonary exercise test. Each session will include 8 intervals of 3 minutes (110-120% of AT-PO) and 8 intervals of 2 minutes of active recovery (70-80% of AT-PO). Training intensity increased by 10% each week while maintaining a Borg scale rating of 13-14, provided that no abnormal cardiovascular or electrocardiographic signs or symptoms were observed. Resistance training will be conducted in 10-minute sessions with at least 6 different exercises using between 40% and 50% of one-repetition maximum (1RM). The 1RM will be calculated using Brzycki's submaximal repetition formula (Weight/(1.0278 - (0.0278\*Reps)). Subsequently, 5 minutes of stretching will be performed as a cool-down.
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Tapered flow resistive load (TFRL)Experimental treatment 2 interventions
Group B: Threshold load (TL)Experimental treatment 2 interventions
Group C: Control Group (CG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Exercise capacity
Improve cardiorespiratory capacity assessed peak oxygen uptake (VO2peak)
Time frame
From enrollment to the end of treatment at 8 weeks2
Maximal inspiratory muscle strength
Improve maximal inspiratory pressure which implies an increase in the values measured in millimeters of mercury (mmHg).
Time frame
From enrollment to the end of treatment at 8 weeks3
Arterial stiffness
Decrease in pulse wave velocity measured using a Holter blood pressure monitor.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Health related quality of life
Health related quality of life will be measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in its valid version in Spanish. Clinically significant improvement: It is generally accepted that a reduction of at least 5 points in the overall score represents a noticeable and beneficial change for the patient.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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