Need of the study :

Cycle ergometer is a training equipment, commonly used in rehabilitation programs that allow monitoring of heart rate (HR), blood pressure (BP). The exercises with the cycle ergometer in phase I of cardiac rehabilitation can improve peripheral muscle strength, functional capacity and perception of dyspnea when used postoperatively and there are speculations if an earlier training contributes to a better postoperative recovery of patients,[7]. Moreover, during Phase – I patients depends on therapists and care givers for progressive exercise training in Heart Valve surgery.

         Due to safety concerns, anxiety and fear of independent walking, the total duration spent on exercise is limited. In order to facilitate early recovery and progressive rehabilitation,   Bicycle ergometer training would be a safe and comfortable training and it would facilitate better patient acceptance and compliance during this period. But these benefits in phase I of the heart valve surgery is not reported  in the literature hence the utility of bicycle ergometer training in Heart Valve surgery is proposed to explore in this study.

AIM OF THE STUDY:

                To compare the efficacy of the routine exercise program and bicycle ergometer  program among Heart Valve surgery patients.

METHODOLOGY:

              An Experimental study is planned to be conducted at the Sri Ramachandra Hospital- Medical Centre, Chennai. An informed consent will be obtained from the study population. By concealed Allocation patients are divided into two groups Routine exercise group and Bicycle ergometer group. Baseline parameters will be Echo, physiological variables and functional capacity – 6MWT.

Study Design:

          Quasi – experimental Study design

Type of study:

           Interventional study

Sample size:

            Required Sample size per group = 17

Inclusion criteria:

·          .  Subjects underwent heart valve surgery

·          Aged 30- 60 years

·          Both genders

·             Oxygen saturation greater than 90% at rest

·              low risk patients (Left ventricular Ejection fraction: >50)

Exclusion criteria:

     Cardiac arrest survivors

     Hemodynamic instability

     INR value < 1.5 and > 3

       Post surgical Cardiac arrhythmias

High risk patient ( AAPCVR and AHA  guidelines )

Procedure:

            Eligible and consented patients would be allocated by concealed allocation method to either of training groups i.e. Routine exercise group and Bicycle ergometer group.

           In Routine exercise group from 3 rd Post operative day till the day of discharge patient receives chest clearance maneuvers and bronchial hygiene when needed, Pulmonary re expansion maneuvers, with a progressive ambulation would be performed. The average duration of the standard physical therapy protocol would be 20 minutes and performed twice (morning and afternoon)

                  In Bicycle ergometer exercise group from 3^rd Post operative day and till the day of discharge patient receives along with Routine exercises and 5 to 15 minutes of bicycle ergometer exercise. Intially pedal timing is calculated. Gradually patient is encouraged to do a continuous training program. Cycling would be interrupted in the presence of signs and symptoms of effort intolerance. During training the Hemodynamics, Rating of Perceived exertion (RPE), HR, Spo2 changes would be monitored (ACSM guidelines).  Precautions in terms of INR value, suture healing status and musculoskeletal limitations would be considered. Load is applied as per patient’s tolerance and comfort to achieve steady self paced pedalling. The sessions include Warm up and cool down for 10 minutes.

OUTCOMES MEASURE :

Functional Capacity (6-Minute Walk Test ): The 6MWT test would be conducted by a physical therapist blinded to the intervention according to the American Thoracic Society protocol. The test would be conducted in a level corridor 30 meters long with markings every 2.5 meters. Participants were oriented to walk as long as possible during six minutes. HR , peripheral oxygen saturation (SpO2 -%), would be monitored during 6MWT. In addition, blood pressure (mmHg) and rating of perceived exertion( Borg’s perceived exertion scale), would be also measured . The 6MWT would performed before training and repeated after training  (before discharge).

         During the test, any sign and symptom resulting from physical exertion were recorded. The outcome chosen for the 6MWT was the maximum distance continuously walked for both intra and inter-group comparison

ECHO: Ejection fraction is taken on pre operative and the before discharge .

PHYSIOLOGICAL VARIABLES:

                   Heart rate, Blood pressure, recovery time, RPE and oxygen saturation changes

STATISTICS:

1.     Paired t test for within group comparison for measured outcomes

2.     Unpaired t test for between group comparison for measured outcomes