Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000, Brazil
Location status: Recruiting
NCT Number: NCT06316349
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
São Paulo, 05403-000, Brazil
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Protocol Discontinuation Criteria:
Exclusion criteria
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.
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.
Time frame: 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).
Time frame: 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 cross-sectional area will be determined by the number and size of individual fibers within the rectus femoris muscle, using the measurement of the anatomical area (cross section of a muscle perpendicular to its longitudinal axis) in centimeters square.
Time frame: 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 pennation angle will be calculated by the intersection of the path between the fascia with the lower aponeurosis of the rectus femoris muscle, measured in degrees.
Time frame: 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.
It will be obtained using digital dynamometry through 3 measurements, with a one-minute interval, and the highest obtained value will be considered, measured in Newtons (N).
Time frame: Immediately before and after the end of the protocol.
Assessed by blood pressure measured by intra aortic baloon pump.
Time frame: Immediately before and after the end of the protocol.
Measured by invasive blood pressure monitoring.
Time frame: Immediately before and after the end of the protocol.
Measured by pulse oximetry.
Time frame: Immediately before and after the end of the protocol.
Measured by blood gas analysis sample.
Time frame: In each intervention period (5 days a week for 21 days).
Bleeding at the femoral insertion or changes in the functioning of the IABP, occurrence of acute arrhythmia or hemodynamic instability ( MAP < 60 mmHg or >120 mmHg or HR < 60 bpm or > 120 bpm).
Interested in participating?
Request InfoUniversity of Sao Paulo General Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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