Coronary Artery Bypass Graft Surgery(CABG)NCT06490458
Effects of Balance Training on Functional Capacity of Patients After Coronary Artery Bypass Grafting Surgery
A study testing Balance Training in people with Coronary Artery Bypass Graft Surgery(CABG), run by Cairo University at 1 site in Egypt.
Trial summary
Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft. Aims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 55 to 65 years, men only
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery(CABG)
- What is being tested?
- Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 10 Dec 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 55 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sixty male patients underwent CABG surgery, their age between 55 to 65 years old.
- All patients were conscious, clinically and medically stable.
- All patients are ambulant independently.
- All patients are haemodynamically stable.
- Good cognition level.
- All patients are conscious and can perform physical activity.
Who cannot join
- Hemodynamic instability.
- Patients who need re-intubation.
- Patients on high inotropic supports.
- Patients with existing pulmonary disease or associated pulmonary complications.
- Recent MI.
- Patients who reported too much pain.
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- Neuromuscular disorders.
- Active hemorrhage and hemoptysis.
- Poor cognition and mentality.
- Unstable angina.
- Decompensated heart failure.
- Deep vein thrombosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Balance Training Post Coronary Artery Bypass Grafting
Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft.
Aims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery.
Read the detailed description
Methods: Sixty male patients under went CABG with ages 55-65 years Patients were randomly randomized into to two groups equal in number 30 in each group. (Group A: study group, Group B: control group).All patients were thoroughly evaluated one day after extubation and day 6 after operation.
Berg Balance Scale (BBS): is a test used to assess patients functional balance , the sit to stand test(STS) used to asses patients functional capacity and SF36 is questionnaire used to assess quality of life with patients. all of those tests done before and after training sessions with both groups. and compare the length of hospital stay between both groups.
- Being tested
- Balance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance TrainingCombination product
Also called cardiac rehabilitation
Balance exercises and cardiac rehabilitation (intervention) for patients for 7 Days, 3 times/week for duration of 25-30 min/ session.
| Study group | Role | What they receive |
|---|---|---|
| Group A :( Study group) | Active comparator | Underwent balance training and cardiac rehabilitation program for a duration of 25-30 min (total session) at a frequency of three times/week (every other day). The balance training was: a- Functional strength exercise b- Stance exercise c- Transition exercise D-Gait training e- Cardiac rehabilitation program . Receives: Combination Product: Balance Training |
| Group B (control group) | Active comparator | underwent cardiac rehabilitation program only for a duration of 25-30 min (total session) at a frequency of three times/week (day after day).
the control group, received cardiac rehabilitation program only. Receives: Combination Product: Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale(BBS)
(0 indicating the lowest level ,4 indicating the highest level ) data about balance from BBS index.
Measured: 7 Days
Secondary outcomes (3)
sit to stand test(SST)in seconds
represent functional capacity (duration of 5 times sit to stand)
Measured: 1st day and 7th day
length of hospital stay (in Days)
number of days spent in hospital
Measured: from 1st day
SF36 Questionnaire( scores)
Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability
Measured: 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Jan 2023
- Primary completion10 Dec 2023
- Study completion10 Dec 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 Coronary Artery Bypass Graft Surgery(CABG)Studies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Institute, Egypt
- Responsible party
- Principal investigator, Hady Atef Labib, Cairo University
- Investigators
- Hady Balabel, phD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490458
- Sponsor's protocol ID
- balance and cabg patients
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after approval can be shared
Publications
Atef H, Marques-Sule E, Moreno-Segura N, Maged A, ELSayed SH, Pengelly J, Ali HF, Ghaffar HAE. Impact of early balance training on recovering following coronary artery bypass grafting. A randomized trial. Clin Rehabil. 2026 Jun;40(6):757-768. doi: 10.1177/02692155251407320. Epub 2025 Dec 30.
PubMed 41468033
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Training Post Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT06490458
- Acronym / sponsor ID
- balance and cabg patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Heart Institute, Egypt
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 8 Jul 2024 (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.
Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft.
Aims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery.
Detailed description
Methods: Sixty male patients under went CABG with ages 55-65 years Patients were randomly randomized into to two groups equal in number 30 in each group. (Group A: study group, Group B: control group).All patients were thoroughly evaluated one day after extubation and day 6 after operation.
Berg Balance Scale (BBS): is a test used to assess patients functional balance , the sit to stand test(STS) used to asses patients functional capacity and SF36 is questionnaire used to assess quality of life with patients. all of those tests done before and after training sessions with both groups. and compare the length of hospital stay between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A :( Study group) | Active comparator | Combination Product: Balance TrainingUnderwent balance training and cardiac rehabilitation program for a duration of 25-30 min (total session) at a frequency of three times/week (every other day). The balance training was: a- Functional strength exercise b- Stance exercise c- Transition exercise D-Gait training e- Cardiac rehabilitation program . |
| Group B (control group) | Active comparator | Combination Product: Balance Trainingunderwent cardiac rehabilitation program only for a duration of 25-30 min (total session) at a frequency of three times/week (day after day). the control group, received cardiac rehabilitation program only. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sixty male patients underwent CABG surgery, their age between 55 to 65 years old.
- All patients were conscious, clinically and medically stable.
- All patients are ambulant independently.
- All patients are haemodynamically stable.
- Good cognition level.
Key exclusion criteria (12 listed)
- Hemodynamic instability.
- Patients who need re-intubation.
- Patients on high inotropic supports.
- Patients with existing pulmonary disease or associated pulmonary complications.
- Recent MI.
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 |
|---|---|---|
| Balance TrainingAlso: cardiac rehabilitationBalance exercises and cardiac rehabilitation (intervention) for patients for 7 Days, 3 times/week for duration of 25-30 min/ session. | Combination product | Group A :( Study group), Group B (control group) |
Primary outcome
Berg balance scale(BBS)
Time frame: 7 Days
(0 indicating the lowest level ,4 indicating the highest level ) data about balance from BBS index.
3 secondary outcomes
sit to stand test(SST)in seconds
Time frame: 1st day and 7th day
length of hospital stay (in Days)
Time frame: from 1st day
SF36 Questionnaire( scores)
Time frame: 3rd day
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 8 Jul 2024.
- Derived from this study: PubMed 41468033Atef H, Marques-Sule E, Moreno-Segura N, Maged A, ELSayed SH, Pengelly J, Ali HF, Ghaffar HAE. Impact of early balance training on recovering following coronary artery bypass grafting. A randomized trial. Clin Rehabil. 2026 Jun;40(6):757-768. doi: 10.1177/02692155251407320. Epub 2025 Dec 30.
- Individual participant dataSharing planned: Yes. after approval can be shared
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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.
Hady Balabel, phD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training in people with Coronary Artery Bypass Graft Surgery(CABG), 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 6 inclusion and 12 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 8 Jul 2024. 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. 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?
Berg balance scale(BBS) (time frame: 7 Days). 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 NCT06490458, 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 8 Jul 2024.