Bedside Cycling Exercises Post Heart Valve Surgeries

NCT ID: NCT05893433

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-06-20

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.

Conditions

Heart Valve Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bedside cycling Group

Participants (25 patients) that will receive bedside cycling:

• Intensity:

1. RPE from 11 to 13 (scale 6-20)

2. Resting HR + 20-30 bpm (up to tolerance if non-symptomatic), from low intensity and progressed to medium intensity.

• Duration: Session duration: Total duration of 20 min, early morning.
• Frequency: once daily from medically stable until discharge. in addition the medical treatment and routinely physiotherapy protocol.

Group Type: EXPERIMENTAL

Bedside cycling

Intervention Type: DEVICE

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:

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 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.

Routine physical therapy Group

participant that will receive only routine physiotherapy treatment protocol and the medical treatment.

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: OTHER

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.

Interventions

Bedside cycling

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:

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 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.

Intervention Type: DEVICE

control

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Salwa Asem Abusarea Milegy

Teaching assistant in faculty of physical therapy Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Heart Institute (NHI)

Giza, , Egypt

Countries

Egypt

References

Ahmad AM, Abusarea SA, Fouad BZ, Guirguis SA, Shafie WA. Effect of Adding Early Bedside Cycling to Inpatient Cardiac Rehabilitation on Physical Function and Length of Stay After Heart Valve Surgery: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Jun;105(6):1050-1057. doi: 10.1016/j.apmr.2024.02.711. Epub 2024 Feb 16.

Reference Type: DERIVED

PMID: 38367831 (View on PubMed)

Other Identifiers

cycling valve surgery

Identifier Type: -

Identifier Source: org_study_id