Clinical trial NCT02657109: Influence of a Rehabilitation in Valve Replacement on Heart Rate Variability and Oxidative Stress
Official title: Influence of Early Mobilization Protocol in Heart Valve Replacement on Heart Rate Variability and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Valve Disease
Keywords: valve replacement
physical therapy
early mobilization
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Heart Rate Variability
timeFrame: one hour
measure: Oxidative stress
timeFrame: one hour
Secondary outcomes:
measure: Hospitalization time evaluation
timeFrame: 1 month
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Hospital de Clínicas Gaspar Viana
state: Pará
Study officials:
affiliation: Universidade Metodista de Piracicaba
name: Rodrigo Batagello, PHD
role: STUDY_DIRECTOR
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