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

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

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte

  lead OTHER

Principal Investigators

• Patrícia A de Miranda Silva Nogueira, Doctorate degree (PhD) · Universidade Federal do Rio Grande do Norte

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-18

Primary Completion

2027-06-30

Completion

2027-12-30

Countries

• Brazil

Study Locations