Clinical trial NCT06316349: Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Physical Therapy
Neuromuscular Electrical Stimulation
Keywords: Heart Failure
Intra-Aortic Ballom Pump
Acquired Muscle Weakness
Neuromuscular Electrical Stimulation
Muscular echo intensity
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Rondomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To investigate echo intensity of the rectus femoris muscle.
timeFrame: 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:
measure: To investigate cross-sectional area of the rectus femoris muscle.
timeFrame: 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.
measure: To investigate pennation angle of the rectus femoris muscle.
timeFrame: 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.
measure: To investigate changes in quadriceps femoral muscle strength.
timeFrame: 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.
measure: To investigate changes in arterial blood pressure during the protocol.
timeFrame: Immediately before and after the end of the protocol.
measure: To investigate changes in heart rate during the protocol.
timeFrame: Immediately before and after the end of the protocol.
measure: To investigate changes in peripheral oxygen saturation during the protocol.
timeFrame: Immediately before and after the end of the protocol.
measure: To investigate changes in the veno-arterial difference in carbon dioxide partial pressure.
timeFrame: Immediately before and after the end of the protocol.
measure: To investigate adverse events:
timeFrame: In each intervention period (5 days a week for 21 days).
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
name: Rafael M Ianotti, PT
role: PRINCIPAL_INVESTIGATOR
References: