Bedside Cycling Exercises Post Heart Valve Surgeries
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      The aim of this clinical trial is to assess the effect of early bedside cycling exercises
      post heart valve surgeries. the main question aims to answer: whether adding an early bedside
      cycling exercise will have an effect on patient's functional capacity, other physical
      outcomes and have an effect on patient's psychological state?

      The participant will be assessed blindly the physical and psychological outcomes before
      getting randomly allocated in groups. the bedside cycling will be introduced and conducted in
      the intervention group in addition to the conventional physical therapy cardiac
      rehabilitation routine through preexisted physical therapy staff who present the hospital:

      The routine use of breathing exercises, coughing techniques, chest wall vibrations, and
      mobilization is common during the first postoperative days.

      On the other hand, the control group will only receive the conventional rehabilitation,
      subsequently, both groups will be assessed and compared by addressing the difference of the
      outcomes before discharging from the hospital.
    

Detailed description: 
      The aim of the study is to assess the effect of early bedside cycling exercises on selected
      physical and psychological outcomes in patients after heart valve surgery.

      This study will be carried out on fifty patients diagnosed with valve heart disease and
      undergoing valve replacement or intervention. They will be recruited from National Heart
      Institute-Cairo, Egypt.

      The purpose, nature and the risk of the study will be explained to the patients and each
      patient will be consented prior to participation in the study.

      The patients in this study will randomly be assigned and randomly allocated into two equal
      groups (n=25), the intervention group will be treated daily from being extubated and being
      relatively stable until discharge from the hospital:

        -  Study group (25 patients): will receive bedside cycling in addition to the medical
           treatment and physiotherapy protocol.

        -  Control group (25 patients): will receive only routine physiotherapy treatment protocol
           and the medical treatment.

      The bedside cycling will be introduced and conducted in the intervention group in addition to
      the conventional phase one of cardiac rehabilitation program through preexisted physical
      therapy staff who present the hospital.

      Bedside cycling: once the patient is relatively stable by weaning off the ventilator and off
      the require inotropic support and continued until the discharge from the hospital.

        -  Intensity:

             1. Rating of Perceived exertion scale (RPE) from 11 to 13 (scale 6-20)

             2. post-surgery: resting HR + 20-30 bpm (up to tolerance if non-symptomatic), from low
                intensity and progressed to medium intensity (According to The American College of
                Sports Medicine (ASCM) recommendations for prescription of the exercises in phase
                one of cardiac rehabilitation).

        -  Duration:

             1. Session duration: Total duration of 20 min, early morning.

             2. Intervention duration: 5-15

             3. Resting as the patient wishes and in case signs of exertion.

             4. Warming up for 5min: low impact, dynamic movement of large group of muscles through
                available Active Range of Motion (ROM) or introduce to cycling, HR after warming up
                10-11 RPE

             5. Cooling down for 5 min or longer: patient observed 30 min after exercise to get to
                Resting Heart Rate (RHR)

             6. Guided by 11-13 RPE, talk test, 20-30 bpm above RHR (Target HR) and sign and
                symptoms for stopping exercise. According ASCM recommendations for prescription of
                the exercises in phase one of cardiac rehabilitation.

        -  Frequency: once daily from medically stable until discharge.

        -  Progression if the following conditions are reached:

             1. Initially increase the duration by up to15 min of low exercise time and then
                increase the intensity after the patient can complete 15- 20 min.

             2. Complete 15min with a medially stable condition

        -  Precaution:

             1. Vital signs before after and within range

             2. Avoid Valsalva maneuver.

                On the other hand, the control group will only receive the conventional
                rehabilitation routine:

        -  The routine use of breathing exercises, coughing techniques, chest wall vibrations, and
           mobilization is common during the first postoperative days.

      Subsequently, both groups will be assessed and compared by addressing the difference of the
      outcomes before discharging from the hospital.
    

Intervention name(s): Bedside cycling; control
Intervention type(s): Device; Other
Intervention description(s): participants receive daily cycling once the patient is relatively stable by weaning off the ventilator and off the require inotropic support and continued to the discharge from the hospital.
Duration progression if the following conditions are reached:
Initially increase the duration by up to15 min of low exercise time and then increase the intensity after the patient can complete 15- 20 min.
Complete 15min with a medially stable condition gradually until reaching 20 minutes besides the routine physical therapy protocol of breathing exercises, coughing techniques, chest wall vibrations, and mobilization is common during the first postoperative days, The two most frequently used breathing techniques were deep breathing exercises and incentive spirometry and the medical treatment.; the routine physical therapy protocol of breathing exercises, coughing techniques, chest wall vibrations, and mobilization is common during the first postoperative days, The two most frequently used breathing techniques were deep breathing exercises and incentive spirometry and the medical treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment