Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06316349

Isolated Resistance Training Program Versus Combined With Neuromuscular Electrical Stimulation for Femoral Quadriceps in Patients With Femoral Intra Aortic Balloon Pump: a Randomized Controlled Trial

Led by University of Sao Paulo General Hospital · Updated on 2024-07-09

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation (NMES) in patients with heart failure who are using a femoral intra-aortic balloon pump. This randomized clinical trial aims to study muscle characteristics such as echo intensity, cross-sectional area, thickness, and pennation angle of the rectus femoris muscle, as well as muscle strength and neuromuscular excitability. The study is designed to address muscle loss and weakness due to bed rest required by the balloon pump treatment. The trial compares two groups: one performing resisted knee extension exercises alone, and the other performing the same exercises synchronized with NMES applied to the femoral quadriceps muscle. Resistance is set based on a one-repetition maximum test and adjusted throughout the intervention. The program runs for 21 days with sessions five days a week, followed by a 14-day follow-up period. Muscle architecture, strength, and neuromuscular excitability are measured at baseline, after 10 and 15 days of intervention, and 14 days after the last session. Participants will undergo assessments including ultrasound scans of the rectus femoris muscle, strength testing with dynamometry, and monitoring of vital signs such as blood pressure, heart rate, and oxygen saturation before and after interventions. Adverse events will be tracked during the intervention period. The overall study duration is 32 days, with detailed evaluations to understand the impact of combining NMES with resistance training in this patient group.

CONDITIONS

Brief Title

Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Use of intra-aortic balloon pump (IABP) for more than 48 hours
  • Dobutamine dose 20 mcg/kg/min or less
  • Norepinephrine dose 0.2 mcg/kg/min or less
  • No device failures or bleeding in the last 24 hours
  • Mean arterial pressure between 60 and 120 mmHg
  • Heart rate between 60 and 120 beats per minute
  • No neurological events causing cognitive or motor deficits
  • No untreated deep venous thrombosis
  • No previous autoimmune diseases
  • No previous rheumatic diseases
Not Eligible

You will not qualify if you...

  • Need for invasive mechanical ventilation
  • Failure to sign or withdrawal of informed consent by patient or family member
  • Need for norepinephrine over 0.2 mcg/kg/min during the study
  • Acute arrhythmia causing hemodynamic instability
  • Hemodynamic instability with mean arterial pressure below 60 mmHg or above 120 mmHg, or heart rate below 60 or above 120 bpm
  • Occurrence of neurological events with cognitive or motor deficits during the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 21 days (5 days per week)

Participants perform a resistance training program with or without neuromuscular electrical stimulation on the femoral quadriceps muscle. The intervention is conducted 5 days per week for 21 days, focusing on knee extension exercises with adjusted resistance load and NMES settings for muscle activation.

Approximately 21 intervention sessions

Follow-up

Duration - 14 days

Participants are followed for 14 days after the last intervention day to assess muscle architecture, strength, and other health measures.

1 follow-up visit after intervention completion

Trial Site Locations

Total: 1 location

1

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil, 05403-000

Actively Recruiting

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Research Team

R

Rafael M Ianotti, PT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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