- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433543
Foam Rolling, Blood Pressure and Range of Motion
February 21, 2026 updated by: Ewan Thomas, University of Palermo
Acute Blood Pressure and Range of Motion Responses to Cervical Foam Rolling: a Randomized Controlled Crossover Trial
Foam rolling (FR) is a technique involving the application of external pressure to muscles and connective tissues using different devices (e.g.
foam rollers, massage rollers, balls, etc.) , with the aim of reducing muscle tension, soreness, and stiffness, and improving circulation, and flexibility.
Emerging evidence suggests that FR may also enhance tissue perfusion and blood flow and could induce a relaxation response, potentially modulating autonomic balance toward increased parasympathetic activity.
The cervical region is of particular interest due to the presence of clinically relevant vascular structures, such as the carotid arteries, whose mechanical stimulation may elicit cardiovascular responses.
Accordingly, the present study was designed to investigate the acute effects of cervical foam rolling on blood pressure, while simultaneously examining tissue hardness and heart rate variability as potential underlying mediators, and to explore a possible dose-response relationship between foam rolling volume and blood pressure through an inter-set analysis.
Additionally, the acute effects of cervical foam rolling on local range of movement were also investigated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Palermo, Italy
- University of Palermo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy participants aged 18 years or older
Exclusion Criteria:
- use of antihypertensive medication;
- orthopedic, neurological, renal, metabolic, or cardiovascular disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cervical foam rolling
Four sets of 45 foam rolls were self-administered on the right posterolateral cervical region, with 45 seconds of recovery between sets.
|
FR condition: Four sets of 45 foam rolls were self-administered, by using a massage roller, on the right posterolateral cervical region, with 45 seconds of recovery between sets.
|
|
No Intervention: Control
Participants in the control condition remained seated for 6 minutes, matching the duration of the FR intervention protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic pressure, diastolic pressure, and mean arterial pressure
Time Frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Systolic and diastolic BP were measured by using a validated oscillometric device.
During the blood pressure assessment, participants were instructed to remain seated and relaxed.
The mean arterial pressure (MAP) was subsequently extrapolated using the following formula: MAP=DP+1/3(SP-DP).
|
- Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
|
Tissue Hardness
Time Frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Tissue hardness was collected using a portable tissue hardness meter.
In the cervical region, the spinous process of C7 was used as the reference point.
Measurements were obtained bilaterally to the C7.
|
- Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
|
Heart rate variability
Time Frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Heart rate variabity was collected using a Polar H10 sensor chest strap device, a device validated for assessment of RR intervals.
|
- Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
|
Cervical range of motion (ROM)
Time Frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Cervical ROM was measured using an inertial measurement unit (GYKO; Microgate, Bolzano, Italy).
The accelerometer was secured to the participant's forehead and measured active cervical flexion, extension, right and left rotation, and right and left inclination.
|
- Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 26, 2025
Primary Completion (Actual)
July 30, 2025
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
February 7, 2026
First Submitted That Met QC Criteria
February 21, 2026
First Posted (Actual)
February 25, 2026
Study Record Updates
Last Update Posted (Actual)
February 25, 2026
Last Update Submitted That Met QC Criteria
February 21, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 60625-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Participants
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Not yet recruitingHealthy Participants | Healthy Adult ParticipantsUnited States
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Touro University, CaliforniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingHealthy Participants | Obese But Otherwise Healthy ParticipantsUnited States
-
Beijing Tide Pharmaceutical Co., LtdRecruitingHealthy | Healthy ParticipantsChina
-
Aston UniversityCooperVision, Inc.Enrolling by invitationHealthy | Healthy ParticipantsUnited Kingdom
-
Universidad San SebastiánAgencia Nacional de Investigación y DesarrolloNot yet recruitingHealthy | Healthy Adult ParticipantsChile
-
Standard Process Inc.Recruiting
-
PfizerCompletedHealthy Subjects | Healthy ParticipantsUnited States
-
Simcere Pharmaceutical Co., LtdNot yet recruiting
-
Fresenius KabiOxford Brookes UniversityNot yet recruiting
Clinical Trials on Cervical foam rolling
-
Federal University of Rio Grande do SulCompleted
-
Celal Bayar UniversityIzmir Katip Celebi UniversityCompleted
-
Celal Bayar UniversityCompleted
-
Charles University, Czech RepublicCompleted
-
University Fernando PessoaCompleted
-
University of PalermoCompleted
-
Dokuz Eylul UniversityCompletedProprioceptive DisordersTurkey
-
Alberto CanzoneUniversity of MessinaCompleted
-
Riphah International UniversityCompletedEffects of Foam Rolling Versus Stretching Exercises on Quadriceps, Hamstrings and Calf Muscle LengthMuscle TightnessPakistan
-
University Fernando PessoaCompleted