Status
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups
Loading...
Central trial contact
EMRE EYNEL, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal