REDUCED FUNCTIONALITY AND KINESIOPHOBIA IN PATIENTS WITH HEART FAILURE: USE OF ALTERNATIVE THERAPEUTIC STRATEGIES

NCT07099495 | Not Yet Recruiting

• 1 other identifier: 84724024.6.0000.5537
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Heart failure (HF) is a clinical syndrome that has advanced on a large scale concomitant with population aging and other factors. Thus, the search for alternatives that minimize the losses resulting from its structural and functional damage are important to optimize its treatments, with the primary objective of enabling the participation of these individuals in the most diverse daily tasks. Low-frequency (LF) or medium-frequency (MF) neuromuscular electrical stimulation (NMES) can be considered a resource to enable the improvement of vital and functional parameters of the population with HF intolerant to physical exercise, and it is also important to identify within these modalities which is most effective. In addition to these factors, kinesiophobia can be found in this population, and NMES can also be adopted as a strategy for kinesiophobia in these patients, with the objective of enabling the progression of behaviors. Objective: To evaluate and compare the effectiveness of LF and MF NMES on the indices of kinesiophobia and functionality in patients with HF. Methods: The research will be divided into two types of study: a double-blind randomized clinical trial (RCT) to evaluate NMES protocols, and a qualitative study with subsequent development and validation of a questionnaire to measure kinesiophobia in individuals with HF. The population included in the RCT will have their assessments (personal, socioeconomic, demographic data, Sit-to-Stand Test, kinesiological ultrasound and surface electromyography of the quadriceps muscles) conducted before their discharge from Hospital Nova Esperança (HNE), and after completion of the protocols at the same institution, in the city of João Pessoa - Paraíba. The application of NMES protocols will be carried out in the home environment (30 min/day, 3 times a week, for a total of 8 consecutive weeks). The population for the qualitative study and for the development of the questionnaire will consist of individuals diagnosed with HF of any etiology, compensated and able to perform kinesiotherapy activities, admitted to the HNE wards, between 24-48 hours before hospital discharge. An in-depth semi-structured interview will be conducted with these individuals, followed by the application of questionnaires developed based on the interviews, and the entire study will be conducted while the patients are hospitalized. Expected results: Regarding the first study, it is expected that patients treated with NMES will show improvements in clinical and functional variables, and these improvements may be more pronounced depending on the frequency applied. On the other hand, the qualitative study may reveal whether patients have fear of movement, even if they are clinically stable. The developed questionnaire will be well understood and have adequate psychometric qualities. Finally, it is expected that this knowledge can serve as a basis for optimizing the care of this patient population.

Conditions

Heart Failure; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Neuromuscular Electrical Stimulation (NMES); Kinesiophobia

Keywords

heart failure; neuromuscular electrical stimulation; kinesiophobia

Outcome Measures

Primary Outcomes (3)

• Muscle strength

  A surface electromyograph (Miotool 400 - Miotec Equipamentos Biomédicos Ltda, POA, Brasil®) will be used to assess muscle production, strength and activation, calculating the maximum power that the patient will make in a voluntary isometric contraction of the quadriceps muscles (rectus femoris, vastus medialis and vastus lateralis), before and after the total NMES protocol.

  In the initial assessment, four weeks after the start of the intervention, at the end of the intervention (eight weeks of intervention), and one month after the complete conclusion of the protocol.

• Muscle thickness

  Functional Kinesiological USG of the quadriceps muscles will be used to assess muscle thickness before starting the protocol, after 4 weeks and after the total intervention protocol with NMES, which may generate functional correlations with the protocol used. The evaluation protocol adopted will be that of Capmbell et al (1995) where quadriceps muscle thickness (QMT) will be quantified by a portable Mindray ultrasound, in B mode, in the supine position, with knees extended and relaxed.

  At baseline, four weeks after the start of the intervention, at the end of the intervention (eight weeks of intervention), and one month after the complete conclusion of the protocol.

• Functional Capacity - 1-Minute Sit-to-Stand Test

  The individual is asked to sit and stand up in a standard-height chair (46-48 centimeters) positioned against a wall. The knees and hips should be flexed at 90 degrees, and the feet should be flat on the floor and hip-width apart. The patient's hands should rest on their hips and no support should be used. Over the course of one minute, the patient should sit and stand up from the chair repeatedly, aiming for as many times as possible. The test begins after a verbal command, and the patient will be notified when 15 seconds remain. The number of repetitions performed is counted and the modified Borg scale will be used to assess dyspnea and fatigue during and at the end of the test (BOHANNON \& CROUCH, 2018).

  At baseline, four weeks after the start of the intervention, at the end of the intervention (eight full weeks of intervention), and one month after the complete conclusion of the protocol.

Secondary Outcomes (2)

• Participation in activities of daily living

  At baseline, four weeks after the start of the intervention, at the end of the intervention (eight full weeks of intervention), and one month after the complete conclusion of the protocol.

• Quality of life of individuals with Heart Failure

  At baseline, four weeks after the start of the intervention, at the end of the intervention (eight full weeks of intervention), and one month after the complete conclusion of the protocol.

Study Arms (3)

Low Frequency Neuromuscular Electrical Stimulation

ACTIVE COMPARATOR

Participants in this group will undergo low-frequency neuromuscular electrostimulation interventions, in accordance with the adopted intervention protocol, with assessments before, after, and at the end of the protocol to observe its effects.

Device: Low Frequency Neuromuscular Electrical Stimulation

Medium Frequency Neuromuscular Electrical Stimulation

ACTIVE COMPARATOR

Participants in this group will undergo medium-frequency neuromuscular electrostimulation interventions, in accordance with the adopted intervention protocol, with assessments before, after, and at the end of the protocol to observe its effects.

Device: Medium Frequency Neuromuscular Electrical Stimulation

Neuromuscular Electrical Stimulation without generating contractility

PLACEBO COMPARATOR

Participants in this group will undergo neuromuscular electrostimulation interventions at a frequency below the contractility threshold, comprising the placebo group, in accordance with the intervention protocol adopted, with assessments before, after, and at the end of the protocol to observe its effects.

Device: Neuromuscular Electrical Stimulation without generating contractility

Interventions

Low Frequency Neuromuscular Electrical Stimulation DEVICE

The surface electrodes will be placed on the upper lateral side of the quadriceps, 5 cm below the inguinal fold and 3 cm above the upper edge of the patella of both lower extremities, bilaterally and with a slight flexion of the knees. They will be fixed with bandages or tape, and conductive gel will be used below the electrodes. Each electrically stimulated contraction will have a frequency of 10 Hz, duration of 10 seconds (ON time: 10s), interspersed with a 20-second rest period (OFF time: 20s), with a pulse width of 400 µs. The protocol will last a total of 8 weeks, being performed 3 times a week, with application of the equipment for 30 minutes each day.

Low Frequency Neuromuscular Electrical Stimulation

Medium Frequency Neuromuscular Electrical Stimulation DEVICE

The surface electrodes will be placed on the upper lateral side of the quadriceps, 5 cm below the inguinal fold and 3 cm above the upper edge of the patella of both lower extremities, bilaterally and with a slight flexion of the knees. They will be fixed with bandages or adhesive tape, and conductive gel will be used below the electrodes. Each electrically stimulated contraction will have a frequency of 50 Hz, duration of 10 seconds (ON time: 10s), interspersed by a period of 20 seconds of rest (OFF time: 20s), with a pulse width of 400 µs. The protocol will last a total of 8 weeks, being performed 3 times a week, with application of the equipment for 30 minutes each day.

Medium Frequency Neuromuscular Electrical Stimulation

Neuromuscular Electrical Stimulation without generating contractility DEVICE

The surface electrodes will be placed on the upper lateral side of the quadriceps, 5 cm below the inguinal fold and 3 cm above the upper edge of the patella of both lower extremities, bilaterally and with a slight flexion of the knees. They will be fixed with bandages or adhesive tape, and conductive gel will be used below the electrodes. No muscle contractions will be generated. The protocol will last a total of 8 weeks, being performed 3 times a week, with application of the equipment for 30 minutes each day.

Neuromuscular Electrical Stimulation without generating contractility

Eligibility Criteria

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

You may qualify if:

• Individuals of both sexes;
• Age ≥ 18 years;
• Diagnosis of chronic HF;
• Symptoms compatible with Functional Class (FC) III-IV of the New York Heart Association (NYHA);
• Stable condition on pharmacological therapy;
• Absence of Acute Myocardial Infarction in the last three months prior to participant recruitment;
• Absence of an automatic internal cardioverter defibrillator (ICD) or cardiac pacemaker;

You may not qualify if:

• Individuals with hemodynamic instability, unstable angina, acute myocardial infarction during the period of application of the protocol and diagnosis of hypertrophic cardiomyopathy during the period of application of the protocol;
• Individuals with recent muscle or tendon injuries, muscular dystrophies, myopathies, unstable fractures, infections or deep vein thrombosis (DVT);
• Chronic need for oxygen therapy;
• Absence in reassessments;
• Refusal to participate in the research after its beginning.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Av Capitão José Pessoa, 870, Jaguaribe

João Pessoa, Paraíba, 58015-345, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Kinesiophobia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Patrícia A de Miranda Silva Nogueira, Doctorate degree (PhD)

  Universidade Federal do Rio Grande do Norte

  STUDY DIRECTOR

Central Study Contacts

Micaele Farias Farias Nascimento, Master's degree

CONTACT

+5583987156995; micaele.farias@hotmail.com

Patrícia A de Miranda Silva Nogueira, Doctorate degree (PhD)

CONTACT

+5584988777454; idpa02@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 1, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For the journal candidate for publication, from the transitional publication period, if necessary.
• Access Criteria: They will be available to the journal applying for publication of the article, if necessary, to ensure the reliability of the study, by email or contact indicated by the journal.

Locations

BR (1)