Cardiac DiseaseNCT06360146
Early Mobilisation of Post Cardiac Surgery in Geriatrics.
A study testing Early mobilisation in people with Cardiac Disease, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease. Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Early mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jun 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals who had previously had valve replacement procedures or coronary artery bypass grafting (CABG) and if all of these procedures were done by sternotomy were included in the study. The study's patients were all classified as geriatric, with ages ranging from 65 to 75. There were people of both genders in the sample. Throughout their recovery, patients who were awake, conscious, and able to communicate vocally as well as those who were able to understand and complete scales and questionnaires. Patients who signed consent forms voluntarily agreed to participate, as well as those who successfully passed the two-minute walk test (2MWT), which assesses how long it takes to walk for two minutes.
Who cannot join
- Patients unable to complete the two-minute walk test (2MWT), scales, or questionnaires. Individuals who suffered from stroke, extensive bleeding, renal failure or insufficiency, atrial fibrillation, the necessity for a second operation, or a serious infection of the sternal wound following surgery. Those who struggle with vocal and auditory communication. individuals who underwent surgery and had a pacemaker inserted. those who have experienced a prior cerebrovascular accident. Those who have suffered from neurological disorders like hemiplegia after heart surgery and mental health problems like intellectual incapacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF EARLY MOBILISATION EXERCISES AND TRADITIONAL PHYSIOTHERAPY FOLLOWING CARDIAC SURGERY ON OLDER PATIENTS
Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.
Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.
Read more
After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.
A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).
Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises.
Read the detailed description
A total of 100 geriatric patients-69 men and 31 women-who had undergone heart surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B). The patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group
- Conditions
- Cardiac Disease
- Being tested
- Early mobilisation
- Keywords
- early rehabilitation, geriatrics, cardiac surgery
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilisationOther
Breathing exercises, inspiratory muscle strength, postural drainage, functional exercise (stand up and sitting down on the chair, walking inward, back-ward ,and sideways), weight shifts from left to right, step up inside the patch , one leg stand, squatting leaning against wall) for three times per the day and repetition fifteen times (3 times per day for 15 repetition) and supervised walking with increments of 2 minutes, as tolerated up to 6 minutes or more at the morning, afternoon, evening and at night.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group Receives: Other: Early mobilisation |
| Group 2 | Active comparator | The patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group Receives: Other: Early mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire
The Short Form of the International Physical Activity Questionnaire (SF-IPAQ) was used to measure physical activity (PA). Participants were asked to describe how many days they had spent performing vigorous, moderate, and walking activities over the course of the previous week, as well as the duration of those activities
Measured: 0-7 days
Secondary outcomes (1)
Two Minute Walking Test
The 2MWT was performed over a 50-ft (15.2-m) out-and-back course. Participants were instructed to walk as fast as they could until asked to stop. They were also told not to worry if they had to slow down or rest, but that if they stopped they should start walking again as soon as they felt ready to do so. When 1 minute had elapsed, they were told "You are doing well; you have 1 minute left." Participants stopped walking at 2 minutes, and the distance covered was documented
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2024 (estimated)
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 Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İSMAİL CEYLAN, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360146
- Sponsor's protocol ID
- 120685123
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khadanga S, Savage PD, Ades PA. Resistance Training for Older Adults in Cardiac Rehabilitation. Clin Geriatr Med. 2019 Nov;35(4):459-468. doi: 10.1016/j.cger.2019.07.005. Epub 2019 Jul 3.
PubMed 31543178
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF EARLY MOBILISATION EXERCISES AND TRADITIONAL PHYSIOTHERAPY FOLLOWING CARDIAC SURGERY ON OLDER PATIENTS
- ClinicalTrials.gov ID
- NCT06360146
- Acronym / sponsor ID
- 120685123
- Conditions
- Cardiac Disease
- Keywords
- early rehabilitation, geriatrics, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 11 Apr 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.
Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.
Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.
After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.
A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).
Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises.
Detailed description
A total of 100 geriatric patients-69 men and 31 women-who had undergone heart surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B). The patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Early mobilisationThe patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group |
| Group 2 | Active comparator | Other: Early mobilisationThe patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Individuals who had previously had valve replacement procedures or coronary artery bypass grafting (CABG) and if all of these procedures were done by sternotomy were included in the study. The study's patients were all classified as geriatric, with ages ranging from 65 to 75. There were people of both genders in the sample. Throughout their recovery, patients who were awake, conscious, and able to communicate vocally as well as those who were able to understand and complete scales and questionnaires. Patients who signed consent forms voluntarily agreed to participate, as well as those who successfully passed the two-minute walk test (2MWT), which assesses how long it takes to walk for two minutes.
Key exclusion criteria (1 listed)
- Patients unable to complete the two-minute walk test (2MWT), scales, or questionnaires. Individuals who suffered from stroke, extensive bleeding, renal failure or insufficiency, atrial fibrillation, the necessity for a second operation, or a serious infection of the sternal wound following surgery. Those who struggle with vocal and auditory communication. individuals who underwent surgery and had a pacemaker inserted. those who have experienced a prior cerebrovascular accident. Those who have suffered from neurological disorders like hemiplegia after heart surgery and mental health problems like intellectual incapacity.
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 |
|---|---|---|
| Early mobilisationBreathing exercises, inspiratory muscle strength, postural drainage, functional exercise (stand up and sitting down on the chair, walking inward, back-ward ,and sideways), weight shifts from left to right, step up inside the patch , one leg stand, squatting leaning against wall) for three times per the day and repetition fifteen times (3 times per day for 15 repetition) and supervised walking with increments of 2 minutes, as tolerated up to 6 minutes or more at the morning, afternoon, evening and at night. | Other | Group 1, Group 2 |
Primary outcome
International Physical Activity Questionnaire
Time frame: 0-7 days
The Short Form of the International Physical Activity Questionnaire (SF-IPAQ) was used to measure physical activity (PA). Participants were asked to describe how many days they had spent performing vigorous, moderate, and walking activities over the course of the previous week, as well as the duration of those activities
1 secondary outcome
Two Minute Walking Test
Time frame: 0-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Background: PubMed 31543178Khadanga S, Savage PD, Ades PA. Resistance Training for Older Adults in Cardiac Rehabilitation. Clin Geriatr Med. 2019 Nov;35(4):459-468. doi: 10.1016/j.cger.2019.07.005. Epub 2019 Jul 3.
- Individual participant dataSharing planned: No
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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 Early mobilisation in people with Cardiac Disease, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Apr 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
International Physical Activity Questionnaire (time frame: 0-7 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 NCT06360146, 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 11 Apr 2024.