Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF

NCT02638961 | Completed DMC

• 1 other identifier: IMT-FES 01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of both improve exercise capacity as well as left ventricular diastolic function, biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.

Conditions

Heart Failure With Normal Ejection Fraction

Keywords

heart failure with preserved ejection fraction; physical therapy; exercise capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg .

  Maximal functional capacity will be evaluated with an incremental and symptom-limited cardiopulmonary exercise testing (CORTEX Metamax 3B) on a bicycle ergometer, beginning with a workload of 10 W and increasing stepwise at 10-W increments every 1 min. During exercise, patients were continuously monitored with twelve-lead electrocardiogram and blood pressure measurements every 2 min. Gas exchange data and cardiopulmonary variables were averaged every 10 seconds values. Peak VO2 is considered the highest value of VO2 during the last 20 s of exercise. The improvement \> of 10% in peak VO2 will be considered clinically meaningful

  changes at 12 weeks and 6 months

Secondary Outcomes (6)

• Functional capacity measured as distance walked in 6 minutes

  changes at 12 weeks and 6 months

• Change in echocardiographic parameter of diastolic disfunction: e' septal (cm/s)

  changes in rest at 12 weeks and 6 months

• Change in echocardiographic parameter of diastolic disfunction: left atrial volume index (mm/m2)

  changes in rest at 12 weeks and 6 months

• Change in echocardiographic parameter of diastolic disfunction: E/e' ratio

  changes in rest at 12 weeks and 6 months

• Change in health-related QoL

  changes at 12 weeks and 6 months

Study Arms (4)

Standard treatment

PLACEBO COMPARATOR

Only standard medical treatment

Other: Standard treatment

IMT group

ACTIVE COMPARATOR

Standard medical treatment associated to Inspiratory muscle training

Other: IMT

FES group

ACTIVE COMPARATOR

Standard medical treatment associated to functional electrostimulation of both legs for 45 minutes a day, 2 days per week for a total of 12 weeks.

Other: FES

IMT+FES group

ACTIVE COMPARATOR

Standard medical treatment associated to combination of inspiratory muscle training and functional electrostimulation of both legs

Other: IMT; Other: FES

Interventions

IMT OTHER

Patients allocated to IMT arm will receive standard medical treatment and will be instructed to train at home twice daily, for 20 minutes each session, and during 12 weeks using a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them will be instructed by a respiratory therapist and educated to maintain a diaphragmatic breathing during the training period. The subjects start breathing at a resistance equal to 25-30% of their maximal inspiratory pressure (MIP) for 1 week. The respiratory therapist examines the patients at weekly intervals by checking the diary card and measuring their MIP each time. The resistance is modified each session according to their 25-30% of their MIP measured.

Also known as: Inspiratory muscular training

IMT group; IMT+FES group

FES OTHER

Patients allocated to FES arm will receive standard medical treatment and will be trained in a FES program of both legs by a physiotherapist for 45 minutes a day, 2 days per week for a total of 12 weeks. Eight adhesive electrodes are positioned on the skin over the quadriceps and gastrocnemius muscles of both legs. The stimulator is configured to deliver a direct electrical current at 25 Hz for 5 seconds followed by a 5-second rest. The intensity of the stimulation is adjusted to achieve a visible muscle contraction without discomfort.

Also known as: Functional electrostimulation of lower limbs

FES group; IMT+FES group

Standard treatment OTHER

Patients allocated to this arm will not receive any physical therapy, only standard medical treatment. They will be checked weekly by a physiotherapist who measures their maximal inspiratory mouth pressure each time.

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous history of symptomatic heart failure NYHA (New York Heart Association )functional class ≥II with Normal left ventricular ejection fraction:
• ejection fraction \>0.50 by Simpson method
• end-diastolic diameter \<60 mm
• Structural heart disease:
• left ventricle hypertrophy/left atrial enlargement and/or
• diastolic dysfunction estimated by 2D echocardiography
• Previous admission for acute heart failure
• Clinical stability, without hospital admissions in the past 3 month

You may not qualify if:

• Perform a valid baseline exercise test
• Significant primary moderate to severe valvular disease
• Acute coronary syndrome or cardiac surgery within the previous three months
• Signs of ischemia during cardiopulmonary exercise testing
• Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease
• Any other comorbidity with an expectancy of life less than one year

Sponsors & Collaborators

• Universitat Jaume I: lead
• Instituto de Investigacion Sanitaria INCLIVA: collaborator
• Hospital Clínico Universitario de Valencia: collaborator

Study Sites (1)

Hospital clínico universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (3)

• Palau P, Dominguez E, Nunez E, Schmid JP, Vergara P, Ramon JM, Mascarell B, Sanchis J, Chorro FJ, Nunez J. Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol. 2014 Dec;21(12):1465-73. doi: 10.1177/2047487313498832. Epub 2013 Jul 17.

  PMID: 23864363 BACKGROUND

• Palau P, Nunez E, Dominguez E, Sanchis J, Nunez J. Physical therapy in heart failure with preserved ejection fraction: A systematic review. Eur J Prev Cardiol. 2016 Jan;23(1):4-13. doi: 10.1177/2047487314562740. Epub 2014 Dec 8.

  PMID: 25488549 BACKGROUND

• Palau P, Dominguez E, Lopez L, Ramon JM, Heredia R, Gonzalez J, Santas E, Bodi V, Minana G, Valero E, Mollar A, Bertomeu Gonzalez V, Chorro FJ, Sanchis J, Lupon J, Bayes-Genis A, Nunez J. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial. Rev Esp Cardiol (Engl Ed). 2019 Apr;72(4):288-297. doi: 10.1016/j.rec.2018.01.010. Epub 2018 Mar 16. English, Spanish.

  PMID: 29551699 DERIVED

Study Officials

• Patricia Palau, M.D., PhD

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

• Eloy Domínguez, M.D

  Universitat Jaume I

  STUDY DIRECTOR

• Julio Núñez, M.D., PhD

  Universitat de Valencia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 23, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

ES (1)