Cardiopulmonary Rehabilitation In Heart Valve Surgery

NCT06493123 | Recruiting

• 1 other identifier: Saglik Bilimleri University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effects of postoperative early mobilization and Bottle-P.E.P. application on respiratory parameters and functional capacity in patients undergoing heart valve surgery.

Conditions

Heart Valve Diseases

Keywords

heart valve surgery; bottle-P.E.P.; early mobilization; cardiopulmonary rehabilitation

Outcome Measures

Primary Outcomes (9)

• European System for Cardiac Operative Risk Evaluation (EuroSCORE):

  Mortality Risk Assessment is a risk scoring system used to predict mortality in the preoperative period in cardiac surgery. EuroSCORE: 0-3 points will be considered Low risk, 4-6 points will be considered Medium risk, 7 and above will be considered High risk.

  Preoperative period

• New York Heart Association (NHYA) Functional Class Assessment:

  The severity of symptoms in heart failure can be graded according to the amount of exertion that produces the symptom. It is a classification that grades heart failure into four separate classes in order to evaluate the effects of heart failure on functional capacity. NYHA Classification - The Stages of Heart Failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

  Preoperative period

• Respiratory function test:

  Patients will be evaluated with spirometric measurements according to the American Thoracic Society and European Respiratory Society guidelines. Absolute values of FEV1, and forced vital capacity (FVC) were obtained, and their percent of the predicted values (% pred) were calculated . An obstructive spirometric pattern was defined as FEV1/FVC \< 70%, and a restrictive spirometric pattern was defined as both FEV1/FVC ≥ 70% and FVC \< 80% pred.

  Preoperative 1st and 7th days

• Baseline transthoracic echocardiography:

  Diastolic dysfunction and reduced ejection fraction (≤ 54% in females, and ≤ 52% in males) were defined according to the current guidelines. Interventricular septal thickness (IVSd), posterior wall thickness (PWd), and LV dimension (LVEDD) were all measured at end-diastole. The LV mass (LVM) was calculated according to the Deveraux formula using these measurements: LVM (g) = 0.80 × {1.04\[(IVSd + LVEDD + PWd)3-(LVEDD)3\]} + 0.6. LVM-index (LVMI) was calculated by dividing LVM by body surface area (BSA). BSA was calculated with the Mosteller formula. LV hypertrophy (LVH) was defined as LVMI ≥ 102 g/m2 for males and ≥ 88 g/m2 for females

  Preoperative 1st and 7th days

• NT-ProBNP measurement:

  NT-proBNP levels are useful in diagnosing heart failure and monitoring treatment effectiveness. High NT-proBNP levels may increase the severity or risk of heart failure. Normal values; For NT-proBNP, \<125 pg/ml (\<450 pg/ml over 75 years of age) is acceptable.

  Preoperative 1st and 7th days

• Functional capacity assessment:

  The 6 Minute Walk Test (6MWT) will be performed according to the recommendations of the American Thoracic Society. Patients will be instructed to walk the longest distance at the fastest speed possible for a period of 6 minutes. The length of the walking track will be 30 m. The physical therapist will provide standard stimulation every minute. If necessary, the patient will be allowed to rest during the test and this time will be included in the total test time. The test will be performed twice with 1-hour intervals between tests. The best distance will be recorded. The minimum clinically significant difference considered will be 25 m.

  Preoperative 1st and 7th days

• The Borg Category-Ratio scale (Borg CR-10) and The Modified Borg Dyspnea Scale (MBS):

  The Borg CR10 is a general intensity scale with specific bases for measuring effort and fatigue. Participants will be asked to mark their perceived level of fatigue on a vertical scale from 0 to 10 before and after the six-minute walk test. The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 numerical score used to measure self-reported dyspnea during submaximal exercise. Participants will be asked to circle or mark the number that best describes their level of dyspnea before and after the six-minute walk test.

  Preoperative 1st and 7th days

• Functional Independence Measurement (FIM):

  The level of independence in daily living activities is an assessment tool used to evaluate the patient's functional status throughout the rehabilitation process. FIM is divided into two domains: Motor and Cognitive. It consists of a total of 18 items, 13 items in the motor domain and 5 items in the cognitive domain. Each item in the FIM is scored on a 7-point Likert scale, and the score indicates the amount of assistance required to accomplish each item. 1 = activities are done completely dependently, 7 = activities are done independently by the individual. A final total score is created and individuals' scores range from 18-126, where a score of 18 represents the individual is completely dependent and 126 represents complete independence.

  Preoperative 1st and 7th days]

• Visual Analog Scale - Pain Assessment:

  Visual Analog Scale (VAS) was used to assess the pain severity of the patients. Chest pain before the operation and incision site pain in addition to chest pain after the operation will be questioned. The minimum clinical significance level for the scale (Minimal clinically important differences) will be taken as an MCID value of 3. VAS is a subjective pain assessment scale that determines pain levels by having patients mark the point where they feel their pain on a 10-centimeter horizontal line. Marked on the scale are 0 - no pain, 10 - unbearable pain. The marked point will be measured with a ruler and recorded.

  Preoperative 1st and 7th days

Secondary Outcomes (5)

• RASS (Richmond Agitation and Sedation Scale):

  Postoperative 1st day in intensive care unit

• Evaluation of hemodynamic and respiratory parameters:

  Postoperative 1st day

• Arterial blood gas measurements:

  Postoperative 1st day in intensive care unit

• Postoperative complication evaluation:

  Postoperative 1st and 7th days

• Length of hospital stay:

  Duration of hospital stay

Study Arms (3)

Group I

EXPERIMENTAL

Group I/Control group: Conventional cardiopulmonary rehabilitation will be applied in the postoperative period.

Other: Conventional Cardiopulmonary Rehabilitation

Group II

EXPERIMENTAL

Group II/ Bottle P.E.P.: Conventional cardiopulmonary rehabilitation and bottle-PEP therapy will be applied in the postoperative period.

Other: Conventional Cardiopulmonary Rehabilitation; Other: Bottle P.E.P. (Pozitive Expiratory Pressure)

Group III

EXPERIMENTAL

Group III/Early Mobilization: Early mobilization program will be started in conventional cardiopulmonary rehabilitation in the postoperative period.

Other: Conventional Cardiopulmonary Rehabilitation; Other: Early Mobilization

Interventions

Conventional Cardiopulmonary Rehabilitation OTHER

Conventional cardiopulmonary applications including positioning, chest physiotherapy, in-bed normal joint movement exercises, sitting and walking, posture exercises

Group I; Group II; Group III

Bottle P.E.P. (Pozitive Expiratory Pressure) OTHER

The device will be built according to the optimal design parameters for a positive expiratory pressure therapy bottle device established by Mestriner et al. According to this Bottle-P.E.P. device: * PEP: 10-20 cmH2O * Inspiration: Expiration Ratio: 1:3-4 * Material Used: Open top plastic bottle, plastic pipe. Plastic Bottle Specifications: I. Material-Hard Plastic II. Dimensions-Weight- 40grams; Height- 25cm; Width- 10cm; Perimeter- 20cm III. Water column height- 13cm Plastic Pipe Properties: I. Material-Pipette II. Inner Diameter- ≥8mm III. Pipe Length- 30cm IV. Depth in the water column - 10cm; 3 cm above the bottom of the bottle surface. \- The distal end of the tube used in the Bottle P.E.P. will be placed 10 cm below the surface, i.e. 10 cm water column and 3 cm above the bottom of the bottle, and the device will be placed on a table in front of the participant.

Group II

Early Mobilization OTHER

The Maebashi mobilization protocol will be followed for early mobilization program. According to this protocol, the hemodynamic and respiratory parameters of the patient will be evaluated first and the patient who meets the criteria for the mobilization program will be started to the mobilization program according to the appropriate stage of the 5-stage mobilization protocol. In Maebashi Mobilization protocol: Level 1: No mobilization and in-bed passive exercise Level 2: Supported in-bed sitting and in-bed active/assistive-active exercise Level 3: Unassisted sitting on the edge of the bed Level 4: Active transfer to chair Level 5: Standing, stepping in place and supported walking about 10 meters (with support of 2 people)

Group III

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• After heart valve surgery: Patients undergoing valvular surgery via sternotomy
• Same surgical technique (from med-sternum)
• Age group (25-75 Y)
• Stable hemodynamic values (stable vital signs, normal temperature, etc.)
• Full awareness of time and space

You may not qualify if:

• Ejection Fraction 35 %
• Any Male/female patient \&lt;25 or \&gt;75
• Body Mass Index (BMI) ≥ 38 kg/m2
• Intubation time \&gt;6 hours after surgery
• Uncontrolled arrhythmias
• Rheumatoid arthritis, other inflammatory and autoimmune diseases
• Active malignancy
• Cardiac pacemaker or defibrillator
• Mental health disorders
• Any postoperative complication (general muscle weakness, wound infection of the sternum or leg, stroke.)
• Refusal to assist in data collection

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Istanbul Provincial Health Directorate Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rezan Aksoy, Ass Prof Dr

  Istanbul Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

  STUDY CHAIR

• Recep Çalışkan, Doctor

  Istanbul Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Dilek Ünsal, PhD MSc PT

CONTACT

+90 530 4641198; ptdilek23@gmail.com

Zuhal Kunduracılar, Prof. Dr.

CONTACT

zuhal.kunduracilar@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: * Group I/Control: Conventional cardiopulmonary rehabilitation will be applied in the postoperative period. * Group II/ Bottle P.E.P.: Conventional cardiopulmonary rehabilitation and bottle-PEP therapy will be applied in the postoperative period. * Group III/Early Mobilization: An early mobilization program will be started in conventional cardiopulmonary rehabilitation in the postoperative period.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: July 9, 2024
• Study Start: April 29, 2024
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)