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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316349
• Other study ID #: CAAE: 75727323.3.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2024
• Est. completion date: March 18, 2026

Study information

• Verified date: June 2024
• Source: University of Sao Paulo General Hospital
• Contact: Rafael M Ianotti, PT
• Phone: +55 11 26615319
• Email: rafael.ianotti[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 35 days, with an initial intervention period of 21 days (5 days per week), followed by a 14-day follow-up period.

Description:

• Introduction: Patients with refractory heart failure who develop cardiogenic shock may require the use of an intra aortic balloon pump. This device, when inserted through the femoral artery, necessitates bed rest and increases the incidence of muscle mass loss. Rehabilitation programs in the intensive care unit that include resistive training bring benefits such as improving muscle architecture, strength, and function. Neuromuscular electrical stimulation (NMES) can be an important tool to assess excitability and improve muscle strength through muscle contractions generated by motor axon depolarization. Muscle ultrasonography is currently used as a tool for evaluating and monitoring muscle architecture (echointensity) and mass.

• Objectives: To evaluate the effect of combining NMES with a standardized exercise program on the echointensity (echogenicity) of the rectus femoris muscle in hemodynamically stable patients using an intra aortic balloon pump.

• Method: This is a randomized controlled clinical trial comparing two groups: one group will perform resisted knee extension exercises in both lower limbs, while the other group will perform the same exercises synchronously with NMES of the femoral quadriceps muscle. The resistance load will be determined by the one-repetition maximum test and adjusted if necessary. The intervention period will be 21 days (5 days/week) with a follow-up of 14 days. Muscle architecture and mass (ultrasonography), neuromuscular excitability (using the same NMES device), and knee extension strength (dynamometry) will be assessed at baseline, on the 14th, 21st, and 35th days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 18, 2026
• Est. primary completion date: March 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Intra-aortic balloon pump (IABP) for more than 48 hours

• Dobutamine = 20 mcg/kg/min

• Norepinephrine = 0.2 mcg/kg/min (35)

• Absence of device failures or bleeding in the last 24 hours

• Mean arterial pressure (MAP) = 60 mmHg and = 120 mmHg

• Heart rate (HR) = 60 bpm and = 120 bpm

• Absence of neurological event with previous cognitive or motor deficit

• Presence of untreated deep venous thrombosis

• Absence of previous autoimmune diseases

• Absence of previous rheumatic diseases

Protocol Discontinuation Criteria:

• Need for norepinephrine > 0.2 mcg/kg/min

• Acute arrhythmia of any etiology with hemodynamic instability

• Hemodynamic instability: MAP < 60 mmHg or >120 mmHg or HR < 60 bpm or > 120 bpm

• Occurrence of neurological event with cognitive or motor deficit

Exclusion Criteria:

• Need for invasive mechanical ventilatory support

• If the patient or responsible family member fails to sign or withdraws the informed consent

Related Conditions & MeSH terms

• Heart Failure
• Neuromuscular Electrical Stimulation
• Physical Therapy

Intervention

Other:
• 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 adjusted weekly if necessary.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate echo intensity of the rectus femoris muscle.	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).	The data will be collected on the day of protocol initiation (Day 0), after 14 days (Day 14), 21 days (Day 21), and 35 days (Day 35).
Secondary	To investigate cross-sectional area of the rectus femoris muscle.	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.	The data will be collected on the day of protocol initiation (Day 0), after 14 days (Day 14), 21 days (Day 21), and 35 days (Day 35).
Secondary	To investigate pennation angle of the rectus femoris muscle.	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.	The data will be collected on the day of protocol initiation (Day 0), after 14 days (Day 14), 21 days (Day 21), and 35 days (Day 35).
Secondary	To investigate changes in quadriceps femoral muscle strength.	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).	The data will be collected on the day of protocol initiation (Day 0), after 14 days (Day 14), 21 days (Day 21), and 35 days (Day 35).
Secondary	To investigate changes in arterial blood pressure during the protocol.	Assessed by blood pressure measured by intra aortic baloon pump.	Immediately before and after the end of the protocol.
Secondary	To investigate changes in heart rate during the protocol.	Measured by invasive blood pressure monitoring.	Immediately before and after the end of the protocol.
Secondary	To investigate changes in peripheral oxygen saturation during the protocol.	Measured by pulse oximetry.	Immediately before and after the end of the protocol.
Secondary	To investigate changes in the veno-arterial difference in carbon dioxide partial pressure.	Measured by blood gas analysis sample.	Immediately before and after the end of the protocol.
Secondary	To investigate adverse events:	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).	In each intervention period (5 days a week for 21 days).