- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657109
Influence of a Rehabilitation in Valve Replacement on Heart Rate Variability and Oxidative Stress
Influence of Early Mobilization Protocol in Heart Valve Replacement on Heart Rate Variability and Oxidative Stress
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pará
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Belém, Pará, Brazil, 66083108
- Hospital de Clínicas Gaspar Viana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volunteers underwent cardiac valve replacement surgery
- Using median sternotomy
- Aged 30 60 years
- Pulse saturation greater than 90%
- BMI ranging between 18.5 and 25 kg / m2
Exclusion Criteria:
- Less than 30 years or over 60 years of age
- Other type of heart surgery than valve replacement, as well valve re-replacement
- Unconscious and level of the Glasgow Coma below scale 15
- Cardiac arrhythmias
- With electrolyte disturbances
- With pleural diseases such as pneumothorax, empyema or pleural effusion
- Circulatory failure acute
- Infections in either system
- Patients with coagulation disorders
- Pulse oxygen saturation lower than 90% even with supplementary oxygen therapy - Hemodynamically unstable supply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Participants are submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists in respiratory exercises of 3 series Inspirations Maximum Sustained for 10 reps, 3 sets of 20 repetitions metabolic exercises with dorsiflexion and plantar flexion and ankle and wrist extension and fingers of the upper limbs.
Assessment of heart rate varibility and oxidative stress carried out before the heart valve replacement surgery , the first day of postoperative and on the fifth postoperative day
|
physiotherapy exercises conducted in early way for the rehabilitation of patients in the postoperative period of cardiac valve replacement.
Other Names:
|
Active Comparator: Early mobilization
Participants performed exercise in cycle ergometer of lower Limbs, pedaling for 20 consecutive minutes at a moderate level with Heart Rate Assessment and the Borg scale to evaluate the Voluntary Comfort.
Assessment of heart rate varibility and oxidative stress carried out before the heart valve replacement surgery , the first day of oepratório post and on the fifth postoperative day
|
physiotherapy exercises conducted in early way for the rehabilitation of patients in the postoperative period of cardiac valve replacement.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability
Time Frame: one hour
|
It will be analyzed the uptake of heart rate variability by means of the heart rate monitor Polar ® brand, model RS800CX where FC signal is received by a strap to the signal receiver, to be placed on the thorax at the level of voluntary xiphoid process.
This capture is stored in the Polar monitor and transferred to the software Polar ProTrainer program by means of an emission of infrared signals interface, where they are stored and subsequently exported to TXT format, which subsequently can be analyzed by a math routine in Kubios HRV® program.
Volunteers will be asked to remain at rest for a period of 10 min, avoiding talking to the researcher so that the heart rate does not undergo changes.
|
one hour
|
Oxidative stress
Time Frame: one hour
|
Morphological evaluation of oxidative stress in the blood plasma is performed by the so called Optical Microscopy Test for In Vitro Analysis Cell or HLB Test. The fingertip of the fourth finger of the previously sanitized hand with alcohol, will collect a drop of blood next to a microscope slide through five light touch of this blade next to the drop . At the end of this period, the morphology of this clot is microscopically observed under a 40-fold increase in optical microscope brand Nikon® model Binocular E200 Standard and its qualitative graduation will be recorded by the camera attached Nikon® mark on a spreadsheet to later analysis. The observation of morphological patterns of the different obtained clots will be held in the first image taken on each of the blades and the evaluation will be conducted through the program called OxyScanner® developed and marketed by Aldea Global Soluciones (AGS). |
one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospitalization time evaluation
Time Frame: 1 month
|
investigate the volunteers of stay in both intervention groups using evaluation of the patients medical records
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1 month
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Collaborators and Investigators
Investigators
- Study Director: Rodrigo Batagello, PHD, Universidade Metodista de Piracicaba
Publications and helpful links
General Publications
- Laitio TT, Huikuri HV, Koskenvuo J, Jalonen J, Makikallio TH, Helenius H, Kentala ES, Hartiala J, Scheinin H. Long-term alterations of heart rate dynamics after coronary artery bypass graft surgery. Anesth Analg. 2006 Apr;102(4):1026-31. doi: 10.1213/01.ane.0000198674.90500.59.
- Brasher PA, McClelland KH, Denehy L, Story I. Does removal of deep breathing exercises from a physiotherapy program including pre-operative education and early mobilisation after cardiac surgery alter patient outcomes? Aust J Physiother. 2003;49(3):165-73. doi: 10.1016/s0004-9514(14)60236-1.
- Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
- Aubert AE, Seps B, Beckers F. Heart rate variability in athletes. Sports Med. 2003;33(12):889-919. doi: 10.2165/00007256-200333120-00003.
- Karemaker JM, Lie KI. Heart rate variability: a telltale of health or disease. Eur Heart J. 2000 Mar;21(6):435-7. doi: 10.1053/euhj.1999.1969. No abstract available.
- Sachdev S, Davies KJ. Production, detection, and adaptive responses to free radicals in exercise. Free Radic Biol Med. 2008 Jan 15;44(2):215-23. doi: 10.1016/j.freeradbiomed.2007.07.019. Epub 2007 Jul 31.
- Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Truong AD, Fan E, Brower RG, Needham DM. Bench-to-bedside review: mobilizing patients in the intensive care unit--from pathophysiology to clinical trials. Crit Care. 2009;13(4):216. doi: 10.1186/cc7885. Epub 2009 Jul 13.
- Silva AP, Maynard K, Cruz MR. Effects of motor physical therapy in critically ill patients: literature review. Rev Bras Ter Intensiva. 2010 Mar;22(1):85-91. English, Portuguese.
- Vaishnav S, Stevenson R, Marchant B, Lagi K, Ranjadayalan K, Timmis AD. Relation between heart rate variability early after acute myocardial infarction and long-term mortality. Am J Cardiol. 1994 Apr 1;73(9):653-7. doi: 10.1016/0002-9149(94)90928-8.
- Wright DJ, Williams SG, Riley R, Marshall P, Tan LB. Is early, low level, short term exercise cardiac rehabilitation following coronary bypass surgery beneficial? A randomised controlled trial. Heart. 2002 Jul;88(1):83-4. doi: 10.1136/heart.88.1.83. No abstract available.
- Zafiropoulos B, Alison JA, McCarren B. Physiological responses to the early mobilisation of the intubated, ventilated abdominal surgery patient. Aust J Physiother. 2004;50(2):95-100. doi: 10.1016/s0004-9514(14)60101-x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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