Coronary Arterial Disease (CAD)SPARROWNCT07087522
Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography
A study testing Stress Ball Use in people with Coronary Arterial Disease (CAD) and Radial Artery Spasm, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, double-blind, controlled trial aims to evaluate the effect of preprocedural hand exercise using a stress ball on the incidence of radial artery spasm and other vascular complications in patients undergoing elective coronary angiography via the transradial approach. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Arterial Disease (CAD), Radial Artery Spasm, Radial Artery Occlusion
- What is being tested?
- Stress Ball Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years
- Elective radial coronary angiography planned
- Written informed consent provided
- Ability to understand and comply with the stress ball exercise protocol (3×5 minutes/day for 3 days prior to procedure)
- Palpable radial pulse on the planned access site
Who cannot join
- Emergent or urgent coronary procedures
- Known radial artery occlusion or non-palpable radial pulse on the intended access side
- Prior arteriovenous fistula or vascular surgery in the ipsilateral arm
- History of Raynaud's disease, severe peripheral artery disease, or Buerger's disease
- Neurological or musculoskeletal disorders affecting hand grip (e.g., stroke, advanced arthritis, peripheral neuropathy)
- Cognitive impairment or psychiatric condition preventing protocol adherence
Show all 9Show fewer
- Inability to use hand muscles effectively (e.g., recent hand trauma, paralysis)
- Unwillingness or inability to perform the stress ball exercises as instructed
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, Adapazarı, 54100
About this study
Official title: Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography: A Randomized Controlled Trial
This randomized, double-blind, controlled trial aims to evaluate the effect of preprocedural hand exercise using a stress ball on the incidence of radial artery spasm and other vascular complications in patients undergoing elective coronary angiography via the transradial approach. A total of 400 adult patients scheduled for elective diagnostic or interventional coronary procedures will be randomly assigned to either an intervention group (preprocedural stress ball exercise) or a control group (standard care). The intervention group will perform hand exercises with a soft stress ball for 5 minutes, three times daily, for three consecutive days prior to the procedure.
The primary outcomes are the incidence of radial artery spasm during the procedure and the overall rate of radial artery complications.
Read more
Secondary outcomes include patient-reported pain score (visual analog scale) during the procedure and the incidence of radial artery occlusion at 7 days, assessed by Doppler ultrasonography.
This study aims to determine whether this simple, low-cost strategy can reduce radial artery-related complications and improve patient comfort during transradial coronary procedures.
Read the detailed description
Radial artery access has become the preferred approach for coronary angiography and percutaneous coronary intervention (PCI) due to its superior safety profile, reduced bleeding complications, earlier patient mobilization, and improved overall comfort compared to the traditional femoral approach. Despite these advantages, transradial procedures are not entirely free of complications. Radial artery spasm (RAS) remains a significant concern, with reported incidence rates ranging from 4% to 20%, depending on operator experience and patient-related factors. Additionally, vascular complications such as hematoma, arterial dissection, pseudoaneurysm, bleeding at the access site, and post-procedural radial artery occlusion (RAO) can affect procedural success and may limit future access via the same route.
Handgrip exercise has been proposed as a simple, non-invasive, and cost-effective strategy to improve arterial compliance, increase vessel diameter, and potentially reduce vasospasm by enhancing endothelial function and promoting local vasodilation. Despite promising physiologic rationale and preliminary findings in other settings (such as arterial diameter augmentation prior to AV fistula creation), the role of preprocedural hand exercise in preventing radial artery complications during coronary procedures has not been systematically studied in a randomized controlled trial.
This single-center, randomized, double-blind, controlled clinical trial aims to assess whether regular preprocedural hand exercise using a soft stress ball can reduce the incidence of RAS and vascular complications in patients undergoing elective coronary angiography via the transradial approach.
A total of 400 adult patients (aged 18 to 85 years), scheduled for elective diagnostic or interventional coronary procedures via the radial artery, will be enrolled. Patients with contraindications to radial access, prior significant upper limb vascular disease, or inability to perform the hand exercise regimen will be excluded.
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a computer-generated randomization sequence. Both the interventional cardiologist performing the procedure and the clinical staff responsible for outcome assessment will remain blinded to group allocation.
Intervention Group: Patients will be instructed to perform handgrip exercises using a soft stress ball for 5 minutes per session, three times per day, for three consecutive days prior to the procedure. Adherence will be monitored through a patient-completed exercise log and direct interview at the time of hospital admission.
Control Group: Patients will receive standard preprocedural care without any specific hand exercise recommendations.
The primary outcomes of the study include:
Incidence of radial artery spasm, defined clinically by resistance to catheter advancement, patient-reported discomfort, or the need for pharmacologic spasmolytics during the procedure.
Overall rate of vascular complications, including access site hematoma, arterial dissection, pseudoaneurysm, and access-related bleeding.
The secondary outcomes include:
Patient-reported pain during radial access, measured using the Visual Analog Scale (VAS).
Incidence of radial artery occlusion (RAO), evaluated at 7 days post-procedure via Doppler ultrasonography.
This study seeks to determine whether a brief period of structured, low-intensity hand exercise can serve as an effective adjunct to routine preprocedural care in patients undergoing transradial coronary angiography. If proven effective, this strategy could be incorporated into standard practice, offering a low-risk and widely applicable method to enhance procedural outcomes, minimize patient discomfort, and preserve radial artery integrity for future access.
Additionally, this trial will contribute valuable data to the growing field of procedural preparation optimization, focusing on patient-involved, non-pharmacological interventions that promote vascular health and procedural success.
- Conditions
- Coronary Arterial Disease (CAD), Radial Artery Spasm, Radial Artery Occlusion, Transradial Angiogram, Visual Analog Pain Scale
- Being tested
- Stress Ball Use
- Keywords
- Radial Artery, Radial Artery Spasm, Radial Artery Occlusion, Coronary Anjiography, Transradial Approach, Hand Exercise, Stress Ball, Vascular Complications
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Ball UseBehavioural
Participants will perform hand exercises using a rubber stress ball for 5 minutes, 3 times daily, for 3 days prior to radial angiography.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Experimental | Participants will perform hand exercises using a stress ball for 5 minutes, 3 times per day, for 3 consecutive days prior to radial angiography. Receives: Behavioral: Stress Ball Use |
| Control Group | No intervention | No hand exercise or stress ball use will be applied before radial angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial Artery Spasm Rate
Incidence of periprocedural radial artery spasm as reported by the operator, characterized by catheter resistance, patient discomfort, or vasodilator need.
Measured: Periprocedural
Pain Score During Procedure (VAS)
Visual Analog Scale (VAS) score reported by the patient (0 = no pain, 10 = worst pain imaginable).
Measured: Immediately after the procedure
Secondary outcomes (3)
Radial Artery Occlusion (RAO)
Radial artery occlusion confirmed by color Doppler ultrasonography. RAO is defined as the absence of flow in the radial artery at the puncture site, assessed in both longitudinal and transverse views.
Measured: 7 days after the procedure
Radial Artery Cannulation Duration
Total time from radial sheath insertion, measured in minutes.
Measured: During radial artery cannulation procedure
Number of Puncture Attempts
Number of needle punctures required for successful access.
Measured: During radial artery cannulation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Sakarya 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intervention group (stress ball use) or the control group (standard care) in a parallel design, with no crossover between groups.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Eynel, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087522
- Sponsor's protocol ID
- SEAH-2025-SPARROW-001
- Acronym
- SPARROW
- Status last verified
- Jul 2025
- First submitted
- 16 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual participant data (IPD) will be made available upon reasonable request after publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07087522
- Acronym / sponsor ID
- SPARROW / SEAH-2025-SPARROW-001
- Conditions
- Coronary Arterial Disease (CAD), Radial Artery Spasm, Radial Artery Occlusion, Transradial Angiogram, Visual Analog Pain Scale
- Keywords
- Radial Artery, Radial Artery Spasm, Radial Artery Occlusion, Coronary Anjiography, Transradial Approach, Hand Exercise, Stress Ball, Vascular Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Jul 2025 (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.
This randomized, double-blind, controlled trial aims to evaluate the effect of preprocedural hand exercise using a stress ball on the incidence of radial artery spasm and other vascular complications in patients undergoing elective coronary angiography via the transradial approach. A total of 400 adult patients scheduled for elective diagnostic or interventional coronary procedures will be randomly assigned to either an intervention group (preprocedural stress ball exercise) or a control group (standard care). The intervention group will perform hand exercises with a soft stress ball for 5 minutes, three times daily, for three consecutive days prior to the procedure.
The primary outcomes are the incidence of radial artery spasm during the procedure and the overall rate of radial artery complications.
Secondary outcomes include patient-reported pain score (visual analog scale) during the procedure and the incidence of radial artery occlusion at 7 days, assessed by Doppler ultrasonography.
This study aims to determine whether this simple, low-cost strategy can reduce radial artery-related complications and improve patient comfort during transradial coronary procedures.
Detailed description
Radial artery access has become the preferred approach for coronary angiography and percutaneous coronary intervention (PCI) due to its superior safety profile, reduced bleeding complications, earlier patient mobilization, and improved overall comfort compared to the traditional femoral approach. Despite these advantages, transradial procedures are not entirely free of complications. Radial artery spasm (RAS) remains a significant concern, with reported incidence rates ranging from 4% to 20%, depending on operator experience and patient-related factors. Additionally, vascular complications such as hematoma, arterial dissection, pseudoaneurysm, bleeding at the access site, and post-procedural radial artery occlusion (RAO) can affect procedural success and may limit future access via the same route.
Handgrip exercise has been proposed as a simple, non-invasive, and cost-effective strategy to improve arterial compliance, increase vessel diameter, and potentially reduce vasospasm by enhancing endothelial function and promoting local vasodilation. Despite promising physiologic rationale and preliminary findings in other settings (such as arterial diameter augmentation prior to AV fistula creation), the role of preprocedural hand exercise in preventing radial artery complications during coronary procedures has not been systematically studied in a randomized controlled trial.
This single-center, randomized, double-blind, controlled clinical trial aims to assess whether regular preprocedural hand exercise using a soft stress ball can reduce the incidence of RAS and vascular complications in patients undergoing elective coronary angiography via the transradial approach.
A total of 400 adult patients (aged 18 to 85 years), scheduled for elective diagnostic or interventional coronary procedures via the radial artery, will be enrolled. Patients with contraindications to radial access, prior significant upper limb vascular disease, or inability to perform the hand exercise regimen will be excluded.
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a computer-generated randomization sequence. Both the interventional cardiologist performing the procedure and the clinical staff responsible for outcome assessment will remain blinded to group allocation.
Intervention Group: Patients will be instructed to perform handgrip exercises using a soft stress ball for 5 minutes per session, three times per day, for three consecutive days prior to the procedure. Adherence will be monitored through a patient-completed exercise log and direct interview at the time of hospital admission.
Control Group: Patients will receive standard preprocedural care without any specific hand exercise recommendations.
The primary outcomes of the study include:
Incidence of radial artery spasm, defined clinically by resistance to catheter advancement, patient-reported discomfort, or the need for pharmacologic spasmolytics during the procedure.
Overall rate of vascular complications, including access site hematoma, arterial dissection, pseudoaneurysm, and access-related bleeding.
The secondary outcomes include:
Patient-reported pain during radial access, measured using the Visual Analog Scale (VAS).
Incidence of radial artery occlusion (RAO), evaluated at 7 days post-procedure via Doppler ultrasonography.
This study seeks to determine whether a brief period of structured, low-intensity hand exercise can serve as an effective adjunct to routine preprocedural care in patients undergoing transradial coronary angiography. If proven effective, this strategy could be incorporated into standard practice, offering a low-risk and widely applicable method to enhance procedural outcomes, minimize patient discomfort, and preserve radial artery integrity for future access.
Additionally, this trial will contribute valuable data to the growing field of procedural preparation optimization, focusing on patient-involved, non-pharmacological interventions that promote vascular health and procedural success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention group (stress ball use) or the control group (standard care) in a parallel design, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Experimental | Behavioral: Stress Ball UseParticipants will perform hand exercises using a stress ball for 5 minutes, 3 times per day, for 3 consecutive days prior to radial angiography. |
| Control Group | No intervention | –No hand exercise or stress ball use will be applied before radial angiography. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 85 years
- Elective radial coronary angiography planned
- Written informed consent provided
- Ability to understand and comply with the stress ball exercise protocol (3×5 minutes/day for 3 days prior to procedure)
- Palpable radial pulse on the planned access site
Key exclusion criteria (9 listed)
- Emergent or urgent coronary procedures
- Known radial artery occlusion or non-palpable radial pulse on the intended access side
- Prior arteriovenous fistula or vascular surgery in the ipsilateral arm
- History of Raynaud's disease, severe peripheral artery disease, or Buerger's disease
- Neurological or musculoskeletal disorders affecting hand grip (e.g., stroke, advanced arthritis, peripheral neuropathy)
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 |
|---|---|---|
| Stress Ball UseParticipants will perform hand exercises using a rubber stress ball for 5 minutes, 3 times daily, for 3 days prior to radial angiography. | Behavioural | Stress Ball Group |
Primary outcome
Radial Artery Spasm Rate
Time frame: Periprocedural
Incidence of periprocedural radial artery spasm as reported by the operator, characterized by catheter resistance, patient discomfort, or vasodilator need.
Pain Score During Procedure (VAS)
Time frame: Immediately after the procedure
Visual Analog Scale (VAS) score reported by the patient (0 = no pain, 10 = worst pain imaginable).
3 secondary outcomes
Radial Artery Occlusion (RAO)
Time frame: 7 days after the procedure
Radial Artery Cannulation Duration
Time frame: During radial artery cannulation procedure
Number of Puncture Attempts
Time frame: During radial artery cannulation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. The de-identified individual participant data (IPD) will be made available upon reasonable request after publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball Use in people with Coronary Arterial Disease (CAD) and Radial Artery Spasm, run by Sakarya University 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMRE EYNEL, MD (+905436342456, emreeynel@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial Artery Spasm Rate (time frame: Periprocedural). The study lists 2 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 28 Jul 2025.