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

Condition(s) studied

Investigational drug(s) / intervention(s)

Isolated Resistance Training Program: The hip range of motion (ROM) will be fixed at 45 degrees due to the limitation imposed by the femoral insertion of the intra-aortic balloon pump in both lower limbs to allow for a 45-degree knee extension ROM. Four sets of 10 knee extension repetitions will be performed with a 90-second rest interval between sets. The intensity (resistive load) will be set at 60% of the baseline load, calculated using the one-repetition maximum (1RM) test and increased by 10% after every 5 interventions.

Neuromuscular electrical stimulation: For NMES, two electrodes (area of 5 x 9 cm) will be positioned perpendicular to the muscles of the femoral quadriceps. The parameters of NMES will remain fixed throughout the study: pulsed, biphasic current, with a frequency of 35Hz, pulse width of 1000µs, on-time of 7 seconds (with 3 seconds of rise, 1 second of sustainment, and 3 seconds of descent), and off-time switched off. These settings allow the onset of NMES to be synchronous with the start and end of hip extension for simultaneous execution with resistance exercises and a total of 40 stimulations. The intensity will be gradually adjusted until evoked contractions of grade 4 to 5 (partial muscle recruitment and total muscle recruitment) or the maximum intensity tolerated by the patient is achieved.

Study summary

The objective of this randomized clinical trial is to compare the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation in patients undergoing heart failure . The main questions it aims to answer are:

* Assessing the ultrasonographic parameters: echo intensity (echogenicity), cross-sectional area, thickness, and pennation angle of the rectus femoris muscle in both lower limbs.
* Evaluating the strength of the femoral quadriceps muscle
* Evaluating the changes in the chronaxie of the rectus femoris muscle in both lower limbs.

The protocol will have a total duration of 32 days, with an initial intervention period of 18 days, followed by a 14-day follow-up period.

Eligibility

Primary outcome measure(s)

• To investigate echo intensity of the rectus femoris muscle. — The data will be collected on the day of protocol initiation (baseline), on the first day after the 10th and 15th days of intervention and on the 14th day after the last day of intervention.
  The ultrasonographic images will be obtained by a portable device in B-mode, using a 6 cm linear array transducer with a frequency range of 6-13MHz. The echointensity value will be acquired through quantitative analysis using the square method, in grayscale, where the average value will be calculated using the histogram function of the dedicated software, in arbitrary units (AU).

Trial sites (1)

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