Influence of a Rehabilitation in Valve Replacement on Heart Rate Variability and Oxidative Stress

NCT02657109 | Completed DMC

• 1 other identifier: 37/2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

4 consecutive days with volunteers between the first and fourth postoperative period of cardiac valve replacement. The volunteers are randomized into 2 groups: the Control Group submitted to cardiac rehabilitation protocol of the hospital where it will be conducted the study, which consists of respiratory and metabolic exercises. The second group, called Early Mobilization Group in addition to the aforementioned exercises will be added exercise in cycle ergometer. For the implementation of rehabilitation protocol in the early mobilization group volunteers will be placed in a sitting position in the bed with the backrest raised to 45 °. The exercise in cycle ergometer will be held for 20 minutes on four consecutive days of active mode, the training load shall be such that the voluntary maintained throughout training a level of fatigue, maintaining level of heart rate predicted for age increased by 70% and 1 w / cm2 every minute to keep the parameter within the standards. The evaluation of heart rate variability with the Polar monitor RS800CX brand model before surgery was performed first postoperative day and fifth postoperative day in the control groups and early mobilization.

Conditions

Cardiac Valve Disease

Keywords

valve replacement; physical therapy; early mobilization

Outcome Measures

Primary Outcomes (2)

• Heart Rate Variability

  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

  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 Outcomes (1)

• Hospitalization time evaluation

  1 month

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: physical therapy procedure

Early mobilization

ACTIVE COMPARATOR

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

Other: physical therapy procedure

Interventions

physical therapy procedure OTHER

physiotherapy exercises conducted in early way for the rehabilitation of patients in the postoperative period of cardiac valve replacement.

Also known as: early mobilization

Control; Early mobilization

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead

Study Sites (1)

Hospital de Clínicas Gaspar Viana

Belém, Pará, 66083108, Brazil

Location

Related Publications (12)

• 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.

  PMID: 16551892 BACKGROUND

• 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.

  PMID: 12952516 RESULT

• 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.

  PMID: 19623052 RESULT

• Aubert AE, Seps B, Beckers F. Heart rate variability in athletes. Sports Med. 2003;33(12):889-919. doi: 10.2165/00007256-200333120-00003.

  PMID: 12974657 RESULT

• 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.

  PMID: 10681483 RESULT

• 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.

  PMID: 18191757 RESULT

• 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.

  PMID: 8598068 RESULT

• 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.

  PMID: 19664166 RESULT

• 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.

  PMID: 25303704 RESULT

• 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.

  PMID: 8166060 RESULT

• 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.

  PMID: 12067954 RESULT

• 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.

  PMID: 15151493 RESULT

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Physical Therapy Modalities; Early Ambulation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Rodrigo Batagello, PHD

  Universidade Metodista de Piracicaba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD STUDENT

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 15, 2016
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2017
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)