CABGNCT06029556
Effects of Early Mobility Protocols in Cardiac ICU
A study testing Mobility out of Bed and Ergometry in Bed in people with CABG, run by Riphah International University at 1 site in Pakistan.
Trial summary
In this study the investigator aim to find the effects of early mobility on different physical activity protocols in post CABG patients. Physical activity, functional status, functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen saturation, length of hospital stay and sternal… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- CABG
- What is being tested?
- Mobility out of Bed and Ergometry in Bed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2022to 1 Oct 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- Both Genders
- Extubated patients with no Complication
- Post CABG (Elective)
- Vitally stable
- 1st CABG
- Selective CABG surgeries
Who cannot join
- Post anesthesia Psychosis
- Corrective surgeries
- Post CABG Stroke
- Infectious wound
- Participants with a physical disability
- Intra-aortic balloon pump (IABP)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Rehman Medical Institute
Peshawar, KPK, 25000
About this study
Official title: Effects of Early Mobilization on Functional Capacity, Physical Activity and Kinesiophobia in Post Coronary Artery Bypass Grafting
In this study the investigator aim to find the effects of early mobility on different physical activity protocols in post CABG patients. Physical activity, functional status, functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen saturation, length of hospital stay and sternal instability. To compare the physical activity protocol used by physical therapist.
Read the detailed description
Current study will compare two different early mobility protocols and will help in assessing best protocol to be use in cardiac ICU for better outcomes of patients.
- Conditions
- CABG
- Being tested
- Mobility out of Bed, Ergometry in Bed
- Keywords
- Early mobility, Physical activity, Kinesiophobia, Functional capacity
- Medical subject headings
- Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility out of BedOther
Active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conduct on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low-intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned
Ergometry in BedOther
Ankle pumps (5*2), knee extension (5*2), breathing exercises with elbow flexion and extension(5*2), spirometry and progressive early ambulation (from bed to wheelchair and wheelchair to standing and from standing to few steps), and conventional chest physical activity (5 minutes on precursor)
| Study group | Role | What they receive |
|---|---|---|
| Mobility out of Bed | Active comparator | Not described Receives: Other: Mobility out of Bed; Other: Ergometry in Bed |
| Ergometry in Bed | Experimental | Not described Receives: Other: Mobility out of Bed; Other: Ergometry in Bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Status score Questionnaire
Five item scale measures the physical performance of patients in ICU.The Functional Status Score for the Intensive Care Unit (FSS-ICU) is a 5-item performance-based measure that utilizes an 8 point, ordinal scale to measure physical function for patients in the intensive care unit setting.
Measured: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
BAECK PHYSICAL ACTIVITY QUESTIONNAIRE
Evaluates the physical activity over the past 12 months. The MBPAQ (BHPAQ) evaluates habitual physical activities in individuals. Activities are scored on a scale of 1-5. A score of 5 indicates the most activity and 1 indicates the least activity for each index.
Measured: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
6 minute walk Test
Sub-maximal test evaluates the aerobic endurance. The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Measured: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Tampa Scale of Kinesiophobia
Evaluate the fear of movement during activity ,17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Changes will be measured at baseline and at completion of 4th week
Measured: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Secondary outcomes (3)
STERNAL INSTABILITY SCALE:
The sternal instability scale (SIS) is a non-invasive manual assessment tool used to detect early bony non-union or instability.
Measured: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
BORG RATING OF PERCEIVED EXERTION
The Borg RPE Scale is a 15-point scale (6 to 20) used to rate subjective experiences during physical exertion. This subjective load scale can help estimate load symptoms, such as the degree of exertion, the degree of load and fatigue.
Measured: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Length of Hospital stay
Total number of days stay in hospital average of days in both group.
Measured: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Dec 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumaiyah Obaid, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029556
- Sponsor's protocol ID
- REC/01373 Sarmad
- Status last verified
- Sep 2023
- First submitted
- 6 Dec 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Mobilization on Functional Capacity, Physical Activity and Kinesiophobia in Post Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT06029556
- Acronym / sponsor ID
- REC/01373 Sarmad
- Conditions
- CABG
- Keywords
- Early mobility, Physical activity, Kinesiophobia, Functional capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Sep 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.
In this study the investigator aim to find the effects of early mobility on different physical activity protocols in post CABG patients. Physical activity, functional status, functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen saturation, length of hospital stay and sternal instability. To compare the physical activity protocol used by physical therapist.
Detailed description
Current study will compare two different early mobility protocols and will help in assessing best protocol to be use in cardiac ICU for better outcomes of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobility out of Bed | Active comparator | Other: Mobility out of Bed, Other: Ergometry in Bed |
| Ergometry in Bed | Experimental | Other: Mobility out of Bed, Other: Ergometry in Bed |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40-70 years
- Both Genders
- Extubated patients with no Complication
- Post CABG (Elective)
- Vitally stable
Key exclusion criteria (6 listed)
- Post anesthesia Psychosis
- Corrective surgeries
- Post CABG Stroke
- Infectious wound
- Participants with a physical disability
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 |
|---|---|---|
| Mobility out of BedActive upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conduct on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low-intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned | Other | Ergometry in Bed, Mobility out of Bed |
| Ergometry in BedAnkle pumps (5*2), knee extension (5*2), breathing exercises with elbow flexion and extension(5*2), spirometry and progressive early ambulation (from bed to wheelchair and wheelchair to standing and from standing to few steps), and conventional chest physical activity (5 minutes on precursor) | Other | Ergometry in Bed, Mobility out of Bed |
Primary outcome
Functional Status score Questionnaire
Time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Five item scale measures the physical performance of patients in ICU.The Functional Status Score for the Intensive Care Unit (FSS-ICU) is a 5-item performance-based measure that utilizes an 8 point, ordinal scale to measure physical function for patients in the intensive care unit setting.
BAECK PHYSICAL ACTIVITY QUESTIONNAIRE
Time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Evaluates the physical activity over the past 12 months. The MBPAQ (BHPAQ) evaluates habitual physical activities in individuals. Activities are scored on a scale of 1-5. A score of 5 indicates the most activity and 1 indicates the least activity for each index.
6 minute walk Test
Time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Sub-maximal test evaluates the aerobic endurance. The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Tampa Scale of Kinesiophobia
Time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Evaluate the fear of movement during activity ,17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Changes will be measured at baseline and at completion of 4th week
3 secondary outcomes
STERNAL INSTABILITY SCALE:
Time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
BORG RATING OF PERCEIVED EXERTION
Time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Length of Hospital stay
Time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
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.
Sumaiyah Obaid, MS principal investigator
Riphah International 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 Mobility out of Bed and Ergometry in Bed in people with CABG, run by Riphah International University at 1 site in Pakistan.
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 7 inclusion and 6 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 14 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 Pakistan. 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?
Contact Sumaiyah Obaid, MS (+923212683462, sumaiyah.obaid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Status score Questionnaire (time frame: Pre Operative (Baseline), 1st Assessment (0 Week) and 2nd Assessment (4 week)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.