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

StatusRecruiting
PhaseNot applicable
Started2024-06-18
View on ClinicalTrials.gov ↗

Amendment history

2026-06-18
Study Status, Sponsor/Collaborators, Contacts/Locations v7
Completion date2026-03-18→2027-05-30
Study sitesdetails revised at 1 of 1 site
2024-07-06
Study Status, Study Description v6
Re-verified, no change to tracked fields
2024-07-03
Study Status, Outcome Measures v5
Secondary endpointsdetails revised at 3 of 8 entries
2024-07-02
Study Status, Study Description, Arms and Interventions, Outcome Measures v4
Secondary endpointsdetails revised at 3 of 8 entries
Study description+53 characters
[...] ension strength (dynamometry) will be assessed at baseline, onafter 10 and 15 days of intervention and after 14 days from the 14th,last 21st,intervention and 35th daysday.
2024-06-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-11-01→2025-03-18
Completion date2026-01-01→2026-03-18
Start dateestimated 2024-06-01→confirmed 2024-06-18
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2024-04-28
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility v2
Primary completion date2025-01-10→2025-11-01
Completion date2025-10-01→2026-01-01
Start date2024-03-20→2024-06-01
Enrollment target68→60
Eligibility criteria+1 characters
[...] pm Occurrence of neurological event with cognitive or motor deficideficit Exclusion Criteria: Need for invasive mechanical ventilator [...]
Secondary endpoints7 to 8 entries
To investigate cross-sectional area of the rectus femoris muscle. To investigate pennation angle of the rectus femoris muscle. To investigate changes in quadriceps femoral muscle strength. To investigate changes in arterial blood pressure during the protocol. To investigate changes in heart rate during the protocol. To investigate changes in peripheral oxygen saturation during the protocol. To investigate changes in the veno-arterial difference in carbon dioxide partial pressure. To investigate adverse events:
Primary endpoints1 entry, revised
To investigate echo intensity of the rectus femoris muscle.
2024-03-16
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v1
Study sitescontacts updated at 1 of 1 site
Study title-8 characters
Isolated Resistance Training Program and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
2024-03-13
Original filing
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.
Trial Details
NCT Number NCT06316349
Lead Sponsor University of Sao Paulo General Hospital
Conditions Heart Failure, Physical Therapy, Neuromuscular Electrical Stimulation
Enrollment 60 participants
Start Date 2024-06-18
Primary Completion 2025-03-18 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-23