Bedside Cycling Exercises Post Heart Valve Surgeries

NCT05893433 | Completed

• 1 other identifier: cycling valve surgery
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

Secondary Outcomes (5)

• Functional Capacity

  1 month follow-up.

• Psychological status

  1 month follow-up.

• the Quality of Life

  1 month follow-up.

• Incidence of adverse event

  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)

  1 month follow-up.

Study Arms (2)

Bedside cycling Group

EXPERIMENTAL

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.

Device: Bedside cycling

Routine physical therapy Group

PLACEBO COMPARATOR

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

Other: control

Interventions

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: 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.

Bedside cycling Group

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.

Routine physical therapy Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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:
• Liver disease e.g. Active cirrhosis or history of previous liver transplant.
• Renal disease e.g. Chronic renal disease, Renal failure.
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Heart Institute (NHI)

Giza, 12651, Egypt

Location

Related Publications (1)

• 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.

  PMID: 38367831 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant in faculty of physical therapy Cairo university

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: June 7, 2023
• Study Start: January 1, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

EG (1)