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

Condition(s) studied

Investigational drug(s) / intervention(s)

Low Frequency Neuromuscular Electrical Stimulation: 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.

Medium Frequency Neuromuscular Electrical Stimulation: 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.

Neuromuscular Electrical Stimulation without generating contractility: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Muscle strength — 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.
  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.
• Muscle thickness — 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 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.
• Functional Capacity - 1-Minute Sit-to-Stand Test — 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.
  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).

Trial sites (1)

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