Heart FailureNCT06316349
Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
A study testing Isolated Resistance Training Program and Neuromuscular electrical stimulation in people with Heart Failure and Physical Therapy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Physical Therapy, Neuromuscular Electrical Stimulation
- What is being tested?
- Isolated Resistance Training Program and Neuromuscular electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Jun 2024to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- Need for invasive mechanical ventilatory support
- If the patient or responsible family member fails to sign or withdraws the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
Silvia HG Lage, MD,PhD
Kelly CO Abud, PT,PhD
About this study
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
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.
Read the 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.
- Being tested
- Isolated Resistance Training Program, Neuromuscular electrical stimulation
- Keywords
- Heart Failure, Intra-Aortic Ballom Pump, Acquired Muscle Weakness, Neuromuscular Electrical Stimulation, Muscular echo intensity
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated Resistance Training ProgramOther
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 stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 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.
Measured: 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 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.
Measured: 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.
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).
Measured: 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.
Assessed by blood pressure measured by intra aortic baloon pump.
Measured: Immediately before and after the end of the protocol.
To investigate changes in heart rate during the protocol.
Measured by invasive blood pressure monitoring.
Measured: Immediately before and after the end of the protocol.
To investigate changes in peripheral oxygen saturation during the protocol.
Measured by pulse oximetry.
Measured: Immediately before and after the end of the protocol.
To investigate changes in the veno-arterial difference in carbon dioxide partial pressure.
Measured by blood gas analysis sample.
Measured: Immediately before and after the end of the protocol.
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).
Measured: In each intervention period (5 days a week for 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start18 Jun 2024
- Primary completion18 Mar 2025
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Rondomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael M. Ianotti, P.T., Ph.D., University of Sao Paulo General Hospital
- Investigators
- Rafael M Ianotti, PT, Principal investigator, Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316349
- Sponsor's protocol ID
- CAAE: 75727323.3.0000.0068
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06316349
- Acronym / sponsor ID
- CAAE: 75727323.3.0000.0068
- Keywords
- Heart Failure, Intra-Aortic Ballom Pump, Acquired Muscle Weakness, Neuromuscular Electrical Stimulation, Muscular echo intensity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Rondomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Isolated Resistance Training Program Group | Active comparator | Other: Isolated Resistance Training ProgramFour sets of 10 knee extension repetitions will be performed with a 90-second rest interval between sets. |
| Neuromuscular Electrical Stimulation Group | Experimental | Other: Neuromuscular electrical stimulationNeuromuscular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (2 listed)
- Need for invasive mechanical ventilatory support
- If the patient or responsible family member fails to sign or withdraws the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolated Resistance Training ProgramThe 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. | Other | Isolated Resistance Training Program Group |
| Neuromuscular electrical stimulationFor 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. | Other | Neuromuscular Electrical Stimulation Group |
Primary outcome
To investigate echo intensity of the rectus femoris muscle.
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).
8 secondary outcomes
To investigate cross-sectional area of the rectus femoris muscle.
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.
To investigate pennation angle of the rectus femoris muscle.
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.
To investigate changes in quadriceps femoral muscle strength.
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.
To investigate changes in arterial blood pressure during the protocol.
Time frame: Immediately before and after the end of the protocol.
To investigate changes in heart rate during the protocol.
Time frame: Immediately before and after the end of the protocol.
To investigate changes in peripheral oxygen saturation during the protocol.
Time frame: Immediately before and after the end of the protocol.
To investigate changes in the veno-arterial difference in carbon dioxide partial pressure.
Time frame: Immediately before and after the end of the protocol.
To investigate adverse events:
Time frame: In each intervention period (5 days a week for 21 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael M Ianotti, PT principal investigator
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated Resistance Training Program and Neuromuscular electrical stimulation in people with Heart Failure and Physical Therapy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael M Ianotti, PT (+55 11 26615319, rafael.ianotti@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate echo intensity of the rectus femoris muscle. (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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.