Cardiopulmonary Rehabilitation In Heart Valve Surgery

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 25 to 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: "Postoperative Mobilization and Bottle-P.E.P. in Heart Valve Surgery:A Prospective Randomized Controlled Study "

Conditions

Heart Valve Diseases

Being tested

Conventional Cardiopulmonary Rehabilitation, Bottle P.E.P. (Pozitive Expiratory Pressure), Early Mobilization

Keywords

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

Medical subject headings

Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Conventional Cardiopulmonary RehabilitationOther

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

• 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:

  1. Material-Hard Plastic II. Dimensions-Weight- 40grams; Height- 25cm; Width- 10cm; Perimeter- 20cm III. Water column height- 13cm

  Plastic Pipe Properties:

  1. 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.

• Early MobilizationOther

  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)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Preoperative period

2. 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.

   Measured: Preoperative period

3. 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.

   Measured: Preoperative 1st and 7th days

4. 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

   Measured: Preoperative 1st and 7th days

5. 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.

   Measured: Preoperative 1st and 7th days

6. 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.

   Measured: Preoperative 1st and 7th days

7. 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.

   Measured: Preoperative 1st and 7th days

8. 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.

   Measured: Preoperative 1st and 7th days]

9. 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.

   Measured: Preoperative 1st and 7th days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 Jul 2024
2. Study start29 Apr 2024
3. Primary completion29 Jan 2025 (estimated)
4. Study completion29 Jan 2025 (estimated)

Why it stopped: The study was cancelled due to a change in the thesis topic before any participants were enrolled.

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.