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

NCT ID: NCT02657109

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-07-31

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.

Detailed Description

The valve disorders are a special group of heart diseases with long period without clinical manifestations, when there is the appearance of symptoms, the patient is a likely candidate for surgery. In many surgical complications can occur, including the respiratory cause and immobility in bed culminating in the need for intensive care. Early mobilization exercises conducted by physical therapy in critically ill patients is to minimize complications related to immobility in bed from surgery that is performed in exchanges of heart valves. To investigate the influence of a cardiac rehabilitation program on cardiac function (Heart Rate Varibility) and free radicals (oxidative stress) in patients undergoing surgical heart valve replacement. The study is being conducted at the Clinical Hospital Gaspar Viana of Belém, in March 2014 period to March 2016, with the proposing institution the Methodist University of Piracicaba. The study included 60 volunteers aged 18 to 60 year old male with surgery scheduling of heart valve replacement. The volunteers were divided into 2 groups the control group who underwent rehabilitation proposed by the hospital with simple exercises like deep breathing exercises to improve cough, move your arms and rhythmically legs to maintain joint mobility, the second group It was called Early Mobilization Group, where volunteers beyond rehabilitation protocol proposed by the hospital, held exercises in a cycle ergometer, The volunteers were instructed to pedal lying comfortably with moderate intensity for 30 minutes. All groups performed this protocol lasting 4 days. Oxidative stress was analyzed and cardiac function before surgery, after surgery in the first and fifth postoperative. The Oxidative Stress is analyzed by puncturing a drop of blood and to analyze the photographed area coagulum formed. Cardiac function (Heart Rate Variability) will be analyzed using a heart rate monitor brand Polar® RS800CX model being evaluated lying down, then the data is transferred to the computer and analyzed in a program called Kubios HRV. After collecting the data will be analyzed in Biostat 5.2 program. The possible risks to the research subject is the inconvenience of collecting the blood sample, the onset of pain resulting from the mobilization of the rehabilitation protocol. However, the emergence of at least one of the risks mentioned above, the procedure and / or service must be stopped and perform passive stretching or temporary home until everything returns to normal. In addition, there may be a risk of contamination to volunteer for collecting blood, however this risk is minimized when using materials such as sterile needles and blades. The research brings benefit as increased range of motion and muscle strength, decreased pain, functional improvement, providing improvement in quality of life and functional independence and reduced hospital stay.

Conditions

Cardiac Valve Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

physical therapy procedure

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

physical therapy procedure

Intervention Type: OTHER

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

Interventions

physical therapy procedure

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

Intervention Type: OTHER

Other Intervention Names

early mobilization

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Metodista de Piracicaba

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Santiago Barbosa Rocha, Phd

PHD STUDENT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Batagello, PHD

Role: STUDY_DIRECTOR

Universidade Metodista de Piracicaba

Locations

Hospital de Clínicas Gaspar Viana

Belém, Pará, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 16551892 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12952516 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19623052 (View on PubMed)

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

Reference Type: RESULT

PMID: 12974657 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10681483 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18191757 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8598068 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19664166 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25303704 (View on PubMed)

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.

Reference Type: RESULT

PMID: 8166060 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12067954 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15151493 (View on PubMed)

Other Identifiers

37/2014

Identifier Type: -

Identifier Source: org_study_id