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

NCT06316349 | Recruiting

• 1 other identifier: CAAE: 75727323.3.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Physical Therapy; Neuromuscular Electrical Stimulation

Keywords

Heart Failure; Intra-Aortic Ballom Pump; Acquired Muscle Weakness; Neuromuscular Electrical Stimulation; Muscular echo intensity

Outcome Measures

Primary Outcomes (1)

• 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 (baseline), on the first day after the 10th and 15th days of intervention and on the 14th day after the last day of intervention.

Secondary Outcomes (8)

• To investigate cross-sectional area 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.

• To investigate pennation angle 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.

• To investigate changes in quadriceps femoral muscle strength.

  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.

• To investigate changes in arterial blood pressure during the protocol.

  Immediately before and after the end of the protocol.

• To investigate changes in heart rate during the protocol.

  Immediately before and after the end of the protocol.

Study Arms (2)

Isolated Resistance Training Program Group

ACTIVE COMPARATOR

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

Other: Isolated Resistance Training Program

Neuromuscular Electrical Stimulation Group

EXPERIMENTAL

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.

Other: Neuromuscular electrical stimulation

Interventions

Isolated Resistance Training Program 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.

Isolated Resistance Training Program Group

Neuromuscular electrical stimulation 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.

Neuromuscular Electrical Stimulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Need for invasive mechanical ventilatory support
• If the patient or responsible family member fails to sign or withdraws the informed consent

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rafael M Ianotti, PT

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael M Ianotti, PT

CONTACT

+55 11 26615319; rafael.ianotti@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for conducting the ultrasonographic measurements will be blinded regarding the randomization and allocation groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)

Model Details: Rondomized controlled trial

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 18, 2024
• Study Start: June 18, 2024
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

BR (1)