Clinical trial NCT05893433: Bedside Cycling Exercises Post Heart Valve Surgeries
Official title: Effect of Early Bedside Cycling Exercises on Selected Physical and Psychological Outcomes in Patients After Heart Valve Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Fifty patients with valvular heart disease (VHD)who have undergone valve surgical intervention
2. Their age between 20-40 years old.
3. Both genders

Exclusion Criteria:

1. Cognitive impairment.
2. Neurological disorders.
3. Sever Musculoskeletal disorders (MSD) e.g. (late stages of osteoarthritis).
4. Underlying pulmonary diseases (aspiration pneumonia, chronic obstructive pulmonary disease, pneumothorax, etc).
5. Presence of comorbidities like:

   1. Liver disease e.g. Active cirrhosis or history of previous liver transplant.
   2. Renal disease e.g. Chronic renal disease, Renal failure.
   3. Complicated operative course: post-operative complication:

a) Presence of preoperative cofounder complication: pulmonary hypertension (Pulmonary artery pressure) = which estimated by right ventricular systolic pressure (RVSP) is greater than 50 mmHg, left ventricular dysfunction which estimated left ventricular ejection fraction equals 40 % or less.

b) Patients with Coronary artery bypass surgery, active infective endocarditis, acute valve dysfunction and other acute urgent conditions.

Primary outcomes:
measure: Functional capacity
timeFrame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
measure: Functional capacity
timeFrame: through study completion, an average of 2 weeks.
measure: Forced Vital Capacity
timeFrame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
measure: Forced Vital Capacity
timeFrame: through study completion, an average of 2 weeks.
measure: Psychological status
timeFrame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
measure: Psychological status
timeFrame: through study completion, an average of 2 weeks.
measure: Activities of Daily Living and Functional level
timeFrame: within the first 24-hour post-surgery
measure: Activities of Daily Living and Functional level
timeFrame: through study completion, an average 7 days
measure: the Quality of Life
timeFrame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
measure: Length of hospital stay
timeFrame: through study completion, an average of 2 weeks.
Secondary outcomes:
measure: Functional Capacity
timeFrame: 1 month follow-up.
measure: Psychological status
timeFrame: 1 month follow-up.
measure: the Quality of Life
timeFrame: 1 month follow-up.
measure: Incidence of adverse event
timeFrame: from the date of beginning cycling intervention or routinely physiotherapy until the date of discharge and will be assessed up to one month.
measure: Prothrombin International Normalized Ratio (INR)
timeFrame: 1 month follow-up.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National Heart Institute (NHI)
Study officials:
References: