Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316349
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-02-19
Brief Title:
Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 daysweek 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
- 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 daysweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None