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

NCT ID: NCT06316349

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-18
• Study Completion Date: 2026-03-18

Brief 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.

Detailed 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, after 10 and 15 days of intervention and after 14 days from the last intervention day.

Conditions

Heart Failure; Physical Therapy; Neuromuscular Electrical Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Isolated Resistance Training Program Group

Four sets of 10 knee extension repetitions will be performed with a 90-second rest interval between sets.

Group Type: ACTIVE_COMPARATOR

Isolated Resistance Training Program

Intervention Type: OTHER

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 Group

Neuromuscular electrical stimulation will be performed in muscles of the femoral quadriceps, simultaneously with the same resistance exercise program as the Isolated Resistance Training Program Group.

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rafael M. Ianotti, PT

Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafael M Ianotti, PT

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Rafael M Ianotti, PT

Role: CONTACT

rafael.ianotti@hc.fm.usp.br

+55 11 26615319

Other Identifiers

CAAE: 75727323.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id