Heart Valve DiseasesNCT05893433
Bedside Cycling Exercises Post Heart Valve Surgeries
A study testing Bedside cycling in people with Heart Valve Diseases, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Bedside cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fifty patients with valvular heart disease (VHD)who have undergone valve surgical intervention
- Their age between 20-40 years old.
- Both genders
Who cannot join
- 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.
Show all 10Show fewer
- Renal disease e.g. Chronic renal disease, Renal failure.
- Complicated operative course: post-operative complication:
- 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.
- Patients with Coronary artery bypass surgery, active infective endocarditis, acute valve dysfunction and other acute urgent conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Bedside Cycling Exercises on Selected Physical and Psychological Outcomes in Patients After Heart Valve Surgery
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:
Read more
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.
Read the 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:
- Rating of Perceived exertion scale (RPE) from 11 to 13 (scale 6-20)
- 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:
- Session duration: Total duration of 20 min, early morning.
- Intervention duration: 5-15
- Resting as the patient wishes and in case signs of exertion.
- 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
- Cooling down for 5 min or longer: patient observed 30 min after exercise to get to Resting Heart Rate (RHR)
- 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:
- 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
- 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.
- Conditions
- Heart Valve Diseases
- Being tested
- Bedside cycling, control
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside cyclingDevice
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.
controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bedside cycling |
| Routine physical therapy Group | Placebo comparator | participant that will receive only routine physiotherapy treatment protocol and the medical treatment. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 2 weeks.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 1 month follow-up.
Incidence of adverse event
the potential incidence of adverse events in both groups will be reported during the study.
Measured: 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.
Measured: 1 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jan 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Asem Abusarea Milegy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893433
- Sponsor's protocol ID
- cycling valve surgery
- Status last verified
- Sep 2023
- First submitted
- 21 Apr 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38367831
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Bedside Cycling Exercises on Selected Physical and Psychological Outcomes in Patients After Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT05893433
- Acronym / sponsor ID
- cycling valve surgery
- Conditions
- Heart Valve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Rating of Perceived exertion scale (RPE) from 11 to 13 (scale 6-20)
- 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:
- Session duration: Total duration of 20 min, early morning.
- Intervention duration: 5-15
- Resting as the patient wishes and in case signs of exertion.
- 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
- Cooling down for 5 min or longer: patient observed 30 min after exercise to get to Resting Heart Rate (RHR)
- 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:
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedside cycling Group | Experimental | Device: Bedside cyclingParticipants (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. |
| Routine physical therapy Group | Placebo comparator | Other: controlparticipant that will receive only routine physiotherapy treatment protocol and the medical treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fifty patients with valvular heart disease (VHD)who have undergone valve surgical intervention
- Their age between 20-40 years old.
- Both genders
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside cyclingparticipants 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. | Device | Bedside cycling Group |
| controlthe 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. | Other | Routine physical therapy Group |
Primary outcome
Functional capacity
Time frame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
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.
Functional capacity
Time frame: through study completion, an average of 2 weeks.
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.
Forced Vital Capacity
Time frame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
measured by Spirometry Pulmonary function test, (THOR laboratory Spiro Tube PC Spirometer) will assess Forced Vital Capacity (FCV) in liters.
Forced Vital Capacity
Time frame: through study completion, an average of 2 weeks.
measured by Spirometry Pulmonary function test, (THOR laboratory Spiro Tube PC Spirometer) will assess Forced Vital Capacity (FCV) in liters.
Psychological status
Time frame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
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.
Psychological status
Time frame: through study completion, an average of 2 weeks.
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.
Activities of Daily Living and Functional level
Time frame: within the first 24-hour post-surgery
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.
Activities of Daily Living and Functional level
Time frame: through study completion, an average 7 days
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.
the Quality of Life
Time frame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.
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.
Length of hospital stay
Time frame: through study completion, an average of 2 weeks.
compare the intervention group to control group length of hospital stay.
5 secondary outcomes
Functional Capacity
Time frame: 1 month follow-up.
Psychological status
Time frame: 1 month follow-up.
the Quality of Life
Time frame: 1 month follow-up.
Incidence of adverse event
Time frame: 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)
Time frame: 1 month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 38367831Ahmad 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside cycling in people with Heart Valve Diseases, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: from the date of patient admission to the hospital until date of the surgical operation, an average of 2 weeks.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.