Coronary Artery DiseaseNCT07475273
The Effectiveness of Early Mobilisation on Back Pain in Patients Following Percutaneous Coronary Intervention
A study testing Early Mobilisation and Standard Post-PCI Care in people with Coronary Artery Disease, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
Percutaneous Coronary Intervention (PCI) is a common revascularization procedure for patients with coronary artery disease. Patients undergoing PCI are often required to remain in a supine position for several hours after the procedure to prevent complications at the vascular access site. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Early Mobilisation and Standard Post-PCI Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Mar 2026to 30 May 2026
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 30-75 years Patients who have undergone PCI through the femoral artery Stable blood pressure and heart rate after PCI Femoral sheath has been removed No major complications after PCI Able to communicate clearly Have not received pain medication No other musculoskeletal problems Willing to participate in the study Willing to sign the informed consent form
Who cannot join
- Unable or unwilling to complete the study PCI performed through the radial artery PCI performed through the brachial artery Chronic back pain before PCI Musculoskeletal problems that affect movement Severe bleeding after PCI Hematoma after PCI
Trial locations and contacts
1 site in 1 country.
About this study
Percutaneous Coronary Intervention (PCI) is a common revascularization procedure for patients with coronary artery disease. Patients undergoing PCI are often required to remain in a supine position for several hours after the procedure to prevent complications at the vascular access site. Prolonged immobilization can lead to discomfort and back pain. Early mobilisation may help reduce back pain and improve patient comfort without increasing the risk of complications.
This study aims to evaluate the effectiveness of early mobilisation in reducing back pain among patients following Percutaneous Coronary Intervention.
Read the detailed description
Percutaneous Coronary Intervention (PCI) is widely performed to restore coronary blood flow in patients with coronary artery disease. After PCI, patients are commonly instructed to remain in a supine position for extended periods to reduce the risk of bleeding at the catheter insertion site. However, prolonged bed rest has been associated with several adverse effects, including lower back pain, discomfort, and reduced patient satisfaction.
Early mobilisation has been proposed as a strategy to reduce these complications while maintaining patient safety. Several studies suggest that allowing patients to mobilise earlier may reduce back pain and improve overall comfort without increasing vascular complications.
This interventional study aims to determine the effectiveness of early mobilisation in reducing back pain among patients following PCI. Participants will be divided into two groups: an intervention group receiving early mobilisation and a control group receiving standard post-PCI care. Back pain intensity will be measured using a validated pain scale at specific time intervals following the procedure.
The findings of this study are expected to provide evidence to support improved nursing care protocols and enhance patient comfort during post-PCI recovery.
- Conditions
- Coronary Artery Disease
- Being tested
- Early Mobilisation, Standard Post-PCI Care
- Keywords
- Early Mobilisation, Percutaneous Coronary Intervention, Back Pain, Post-PCI Care, Cardiac Nursing
- Medical subject headings
- Coronary Artery Disease, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early MobilisationOther
Early mobilisation includes gradual mobilisation such as head-of-bed elevation and controlled body movement initiated earlier after Percutaneous Coronary Intervention (PCI) under nurse supervision to reduce back pain.
Standard Post-PCI CareOther
Standard post-procedure care following Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol without early mobilisation.
| Study group | Role | What they receive |
|---|---|---|
| Early Mobilisation Group | Experimental | Participants in this group will receive early mobilisation after Percutaneous Coronary Intervention (PCI). Early mobilisation includes gradual body movement and elevation of the head of the bed under nurse supervision to reduce back pain following the procedure. Receives: Other: Early Mobilisation |
| Standard Care Group | Active comparator | Participants in this group will receive standard post-procedure care after Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol. Receives: Other: Standard Post-PCI Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back Pain Intensity
Back pain intensity measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start30 Mar 2026
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Participants will be randomly assigned to either the early mobilisation intervention group or the standard care control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SANTISIHOMBING, Universitas Sumatera Utara
- Investigators
- Sa Ranti Lina Sihombing, SKep.,Ners, Principal investigator, Magister of Nursing, Faculty of Nursing ,North Of Sumatra university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475273
- Sponsor's protocol ID
- 140/KEPK/USU/2026
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient confidentiality and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Early Mobilisation on Back Pain in Patients Following Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07475273
- Acronym / sponsor ID
- 140/KEPK/USU/2026
- Conditions
- Coronary Artery Disease
- Keywords
- Early Mobilisation, Percutaneous Coronary Intervention, Back Pain, Post-PCI Care, Cardiac Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 16 Mar 2026 (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.
Percutaneous Coronary Intervention (PCI) is a common revascularization procedure for patients with coronary artery disease. Patients undergoing PCI are often required to remain in a supine position for several hours after the procedure to prevent complications at the vascular access site. Prolonged immobilization can lead to discomfort and back pain. Early mobilisation may help reduce back pain and improve patient comfort without increasing the risk of complications.
This study aims to evaluate the effectiveness of early mobilisation in reducing back pain among patients following Percutaneous Coronary Intervention.
Detailed description
Percutaneous Coronary Intervention (PCI) is widely performed to restore coronary blood flow in patients with coronary artery disease. After PCI, patients are commonly instructed to remain in a supine position for extended periods to reduce the risk of bleeding at the catheter insertion site. However, prolonged bed rest has been associated with several adverse effects, including lower back pain, discomfort, and reduced patient satisfaction.
Early mobilisation has been proposed as a strategy to reduce these complications while maintaining patient safety. Several studies suggest that allowing patients to mobilise earlier may reduce back pain and improve overall comfort without increasing vascular complications.
This interventional study aims to determine the effectiveness of early mobilisation in reducing back pain among patients following PCI. Participants will be divided into two groups: an intervention group receiving early mobilisation and a control group receiving standard post-PCI care. Back pain intensity will be measured using a validated pain scale at specific time intervals following the procedure.
The findings of this study are expected to provide evidence to support improved nursing care protocols and enhance patient comfort during post-PCI recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the early mobilisation intervention group or the standard care control group.
| Arm | Type | Receives |
|---|---|---|
| Early Mobilisation Group | Experimental | Other: Early MobilisationParticipants in this group will receive early mobilisation after Percutaneous Coronary Intervention (PCI). Early mobilisation includes gradual body movement and elevation of the head of the bed under nurse supervision to reduce back pain following the procedure. |
| Standard Care Group | Active comparator | Other: Standard Post-PCI CareParticipants in this group will receive standard post-procedure care after Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 30-75 years Patients who have undergone PCI through the femoral artery Stable blood pressure and heart rate after PCI Femoral sheath has been removed No major complications after PCI Able to communicate clearly Have not received pain medication No other musculoskeletal problems Willing to participate in the study Willing to sign the informed consent form
Key exclusion criteria (1 listed)
- Unable or unwilling to complete the study PCI performed through the radial artery PCI performed through the brachial artery Chronic back pain before PCI Musculoskeletal problems that affect movement Severe bleeding after PCI Hematoma after PCI
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 MobilisationEarly mobilisation includes gradual mobilisation such as head-of-bed elevation and controlled body movement initiated earlier after Percutaneous Coronary Intervention (PCI) under nurse supervision to reduce back pain. | Other | Early Mobilisation Group |
| Standard Post-PCI CareStandard post-procedure care following Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol without early mobilisation. | Other | Standard Care Group |
Primary outcome
Back Pain Intensity
Time frame: Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group
Back pain intensity measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
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 31 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient confidentiality and institutional data protection policies.
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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.
Sa Ranti Lina Sihombing, SKep.,Ners principal investigator
Magister of Nursing, Faculty of Nursing ,North Of Sumatra 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 Early Mobilisation and Standard Post-PCI Care in people with Coronary Artery Disease, run by Universitas Sumatera Utara at 1 site in Indonesia.
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: finished, as of the sponsor's last update on 31 Aug 2026. 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 Indonesia. 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?
Back Pain Intensity (time frame: Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group). 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 31 Aug 2026.