An interventional study of LLLT and traditional physical therapy in Heart Arrhythmia, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
Increase in heart rate (HR) is a normal sympathetic response to body trauma and a common consequence of major surgical procedures,A high resting HR is associated with increased myocardial work that may be detrimental to patients with a marginal myocardial oxygen supply,the aim of this study is To compare between the effects of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery.
Autonomic function reached lowest values 3-6 days after coronary artery by pass graft (CABG) and could take up to 60 days to return to pre-surgery values (pedro et al., 2005).
Alterations in pulse may provide a first indication that a patient is developing hemodynamic instability. While many factors may influence the pulse rate, including fever, exercise, medications, and thyroid hormone status, a high pulse rate is often a sign of high levels of endogenous catecholamines, blood loss or dehydration (Jonathan ,2009.) Hemodynamically unstable patients don't have enough pressure in the circulatory system to keep blood flowing reliably to all the various parts of the body where it needs to be at the same time.
Vagus nerve stimulation (VNS) can increase HRV and reduce sympathetic nerve outflow, which is desirable in conditions characterized by enhanced sympathetic nerve activity .
Application of Acu-TENS over acu-point PC6 facilitated a faster return of resting HR to preoperative levels, maintained BP during the acute postoperative period and enhanced a quicker return of rate pressure product (RPP), in patients after acute cardiac surgery .
Faster return of the raised resting HR to preoperative levels in Acu-TENS application was possibly due to induced vagal stimulation and/or inhibition of sympathetic neural activity through the acu-points PC6 .
Low level laser therapy (LLLT) is a non-invasive and safe method, to recover parasympathetic/sympathetic nervous system balance .
this study show the differences between the effect of Acu TENS and low level laser therapy on autonomic and hemodynamic instability after open heart surgery
915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's enrollment of 60 is below the median of 97 across 443 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
The LLLT group consist of (20) patients, who will receive the vagus nerve stimulation through LLLT from the first day postoperative until the seventh day, in addition to routine physiotherapy program
Device: LLLT · Other: traditional physical therapy
The acu tense group consist of (20) patients, who will receive the acu tens on (pc6) point from the first day postoperative until the seventh day, in addition to routine physiotherapy program
Other: traditional physical therapy · Device: ACU TENSE
The control group consist of (20) patients, who will receive only routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)
Other: traditional physical therapy
low level laser therapy Probe laser device: (Laserklasse2M, EN60825-1, +A2:2002, W.L= 635-670nm, P\<6mW, German):low level laser therapy It will be used to stimulate vagus nerve .
traditional physical therapy include (phase I cardiac rehabilitation, breathing exercises, modified postural drainage, percussion and vibration)
Acu-TENS device (Digital TENS, EAF20, JERF20BD0604, add manufacturing country): It will be used to stimulate vagus nerve throug h the acupoint PC6 .
heartrate variability.
SDANN Standard deviation of the averages of RR intervals in all 50minute segments of a 24-hour recording.rMSSD Square root of the mean of the squares of differences between adjacent RR intervals
Time frame: heart rate variability parameters recorded for 24 hours 1st day post operative and at the last day before discharge from hospital for each group. before discharge from hospital .
Atrial fibrillation
Atrial fibrillation occurs in 10% to 65% of patients after cardiac surgery, usually on the second or third postoperative day. Postoperative atrial fibrillation is associated with increased morbidity and mortality and longer, more expensive hospital stay
Time frame: AF recorded in 24 hours 1st day post operative and at the last day before discharge from hospital for each group.
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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