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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.
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:
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:
Duration:
Frequency: once daily from medically stable until discharge.
Progression if the following conditions are reached:
Precaution:
Vital signs before after and within range
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bedside cycling Group | Experimental | Participants (25 patients) that will receive bedside cycling:
|
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| Routine physical therapy Group | Placebo Comparator | participant that will receive only routine physiotherapy treatment protocol and the medical treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedside cycling | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity | measured by Six Minutes Walk Test, it will be performed on a flat surface, with a predetermined distance 30 meters measured and marked off. Patients will be asked to walk self-paced back and forth between the 2 marked points for 6 minutes. Rests are allowed, and administrators are able to provide standardized feedback during and at the end of the test, The laps are counted, and a distance walked in 6 minutes is determined. | from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks. |
| Functional capacity | measured by Six Minutes Walk Test, it will be performed on a flat surface, with a predetermined distance 30 meters measured and marked off. Patients will be asked to walk self-paced back and forth between the 2 marked points for 6 minutes. Rests are allowed, and administrators are able to provide standardized feedback during and at the end of the test, The laps are counted, and a distance walked in 6 minutes is determined. | through study completion, an average of 2 weeks. |
| Forced Vital Capacity | measured by Spirometry Pulmonary function test, (THOR laboratory Spiro Tube PC Spirometer) will assess Forced Vital Capacity (FCV) in liters. | from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks. |
| Forced Vital Capacity | measured by Spirometry Pulmonary function test, (THOR laboratory Spiro Tube PC Spirometer) will assess Forced Vital Capacity (FCV) in liters. | through study completion, an average of 2 weeks. |
| Psychological status | The Depression Anxiety Stress Scales 42 were used to measure three negative emotional states (depression, anxiety, and stress) experienced by the patients in the previous week. A higher score on the scale indicates a more severe condition, with the highest possible score being 126 and the lowest score being 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Capacity | measured by Six Minutes Walk Test (6MWT), it will be performed on a flat surface, with a predetermined distance 30 meters measured and marked off. Patients will be asked to walk self-paced back and forth between the 2 marked points for 6 minutes. Rests are allowed, and administrators are able to provide standardized feedback during and at the end of the test, The laps are counted, and a distance walked in 6 minutes is determined. |
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Inclusion Criteria:
Exclusion Criteria:
Cognitive impairment.
Neurological disorders.
Sever Musculoskeletal disorders (MSD) e.g. (late stages of osteoarthritis).
Underlying pulmonary diseases (aspiration pneumonia, chronic obstructive pulmonary disease, pneumothorax, etc).
Presence of comorbidities like:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart Institute (NHI) | Giza | 12651 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38367831 | Derived | 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. |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Patient are masked through out the study and health care providers who provide routine care of the patient whether are nurses, physicians or existed physiotherapist are also masked
|
| control | 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. |
|
| from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks. |
| Psychological status | The Depression Anxiety Stress Scales 42 were used to measure three negative emotional states (depression, anxiety, and stress) experienced by the patients in the previous week. A higher score on the scale indicates a more severe condition, with the highest possible score being 126 and the lowest score being 0. | through study completion, an average of 2 weeks. |
| Activities of Daily Living and Functional level | measuring Activities of Daily Living and Function level by using Barthel Index, the current level of 10 items the maximum score is 100, the lower scores ranging from 0- 20 indicating increased disability. | within the first 24-hour post-surgery |
| Activities of Daily Living and Functional level | measuring Activities of Daily Living and Function level by using Barthel Index, the current level of 10 items the maximum score is 100, the lower scores ranging from 0- 20 indicating increased disability. | through study completion, an average 7 days |
| the Quality of Life | The Short Form-12 Health Questionnaire was used to measure the Quality of Life over the past 4 weeks, consisting of two components: physical and mental. The highest possible score for the mental component was 60.75781, indicating a better mental condition. Similarly, the highest possible score for the physical component was 56.577706, indicating a better physical condition. | from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks. |
| Length of hospital stay | compare the intervention group to control group length of hospital stay. | through study completion, an average of 2 weeks. |
| 1 month follow-up. |
| Psychological status | The Depression Anxiety Stress Scales 42 were used to measure three negative emotional states (depression, anxiety, and stress) experienced by the patients in the previous week. A higher score on the scale indicates a more severe condition, with the highest possible score being 126 and the lowest score being 0. | 1 month follow-up. |
| the Quality of Life | The Short Form-12 Health Questionnaire was used to measure the Quality of Life over the past 4 weeks, consisting of two components: physical and mental. The highest possible score for the mental component was 60.75781, indicating a better mental condition. Similarly, the highest possible score for the physical component was 56.577706, indicating a better physical condition. | 1 month follow-up. |
| Incidence of adverse event | the potential incidence of adverse events in both groups will be reported during the study. | from the date of beginning cycling intervention or routinely physiotherapy until the date of discharge and will be assessed up to one month. |
| Prothrombin International Normalized Ratio (INR) | Prothrombin International Normalized Ratio (INR) in the Coagulation profile in both groups will be assessed and provided at one-month follow-up. | 1 month follow-up. |