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Search / Trial NCT07099495

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

Launched by UNIVERSIDADE FEDERAL DO RIO GRANDE DO NORTE · Jul 24, 2025

Trial Information

Current as of August 27, 2025

Not yet recruiting

Keywords

Heart Failure Neuromuscular Electrical Stimulation Kinesiophobia

ClinConnect Summary

This clinical trial is studying a new way to help people with heart failure, especially those who have difficulty moving and fear physical activity, a condition known as kinesiophobia. The study is testing two types of gentle electrical stimulation called neuromuscular electrical stimulation (NMES) to see if they can improve muscle function and reduce fear of movement in patients who find exercise difficult. This treatment involves using small electrical pulses to stimulate leg muscles at home for about 30 minutes, three times a week, over eight weeks.

Adults aged 18 and older with chronic heart failure classified as moderate to severe (NYHA Class III or IV) and who are stable on medication may be eligible to participate. People with recent heart attacks, certain heart devices, or serious muscle or health problems will not be included. Participants can expect to have muscle and movement tests done before starting and after finishing the treatment, with the stimulation sessions done at home. The study also includes interviews to better understand patients’ fears about moving and to develop a questionnaire to measure this fear. The goal is to find effective ways to help people with heart failure improve their daily activities and quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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;
  • Exclusion Criteria:
  • 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.

About Universidade Federal Do Rio Grande Do Norte

The Universidade Federal do Rio Grande do Norte (UFRN) is a prestigious Brazilian institution dedicated to advancing education, research, and innovation in various fields, including health sciences. As a clinical trial sponsor, UFRN leverages its robust academic and research capabilities to contribute to the development of effective medical interventions and therapies. The university fosters collaborative partnerships with healthcare professionals, researchers, and industry stakeholders, ensuring that clinical trials conducted under its auspices adhere to the highest ethical standards and regulatory requirements. UFRN is committed to enhancing public health outcomes through rigorous scientific inquiry and the translation of research findings into clinical practice.

Locations

João Pessoa, , Brazil

Patients applied

0 patients applied

Trial Officials

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

Study Director

Universidade Federal do Rio Grande do Norte

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported