Healthy Young AdultsNCT07520474
Foam Rolling and Blood Pressure
A study testing Foam Rolling Intervention (FR) in people with Healthy Young Adults and Healthy Adult Participants, run by University of Palermo at 1 site in Italy.
Trial summary
Foam rolling (FR) has emerged as a widely adopted modality among rehabilitation practitioners and physically active populations. Previous investigations on FR have reported improvements in joint range of motion, small to trivial enhancements in selected performance measures, attenuation of exercise-induced muscle… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults, Healthy Adult Participants, Healthy Participants
- What is being tested?
- Foam Rolling Intervention (FR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2025to 10 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, normotensive men and women aged 18 years or older
- female participants were recruited during the follicular phase of their menstrual cycle
Who cannot join
- orthopedic disorders
- neurological disorders
- renal disorders
- metabolic disorders
- musculoskeletal disorders
- cardiovascular disorders
- current use of any form of contraception
- use of antihypertensive medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Blood Pressure Responses to Operator-administered Foam Rolling of the Right Thigh: A Randomized Controlled Crossover Trial
Foam rolling (FR) has emerged as a widely adopted modality among rehabilitation practitioners and physically active populations. Previous investigations on FR have reported improvements in joint range of motion, small to trivial enhancements in selected performance measures, attenuation of exercise-induced muscle soreness, and reductions in pain perception. While the evidence base supporting range-of-motion, performance, muscle soreness and pain sensitivity adaptations is relatively well developed, considerably less attention has been directed toward the blood pressure responses to FR and the potential underlying mechanisms. Consequently, the physiological impact of FR on cardiovascular regulation in healthy, normotensive young adults remains insufficiently characterized and requires further systematic investigation. An acute reduction in blood pressure may be postulated, potentially mediated by mechanisms involving changes in total peripheral resistance, which could be linked to modifications in tissue mechanical characteristics. In parallel, a contributory role of autonomic regulation cannot be excluded, as shifts in sympathetic and parasympathetic activity may also influence cardiovascular responses.
- Being tested
- Foam Rolling Intervention (FR)
- Keywords
- massage roller, cardiovascular health, stiffness, peripheral resistance, heart rate variability, foam rolling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam Rolling Intervention (FR)Other
The FR intervention was conducted using a Theraband® Roller Massager (The Hygenic Corporation, Akron, OH, USA). All procedures were performed exclusively on the right thigh and administered by the same investigator to ensure methodological consistency. The protocol included a total of eight sets, four per muscle group (hamstrings and quadriceps of the right thigh), resulting in an overall intervention duration of 4 minutes (2 minutes allocated to the hamstrings and 2 minutes to the quadriceps). Each muscle group underwent four sets of 30 rolling repetitions executed at a controlled cadence of one repetition per second, yielding 30 seconds of continuous rolling per set. No other drugs or devices were involved in the procedural interventions.
| Study group | Role | What they receive |
|---|---|---|
| Foam Rolling Intervention (FR) | Experimental | The FR intervention was conducted using a Theraband® Roller Massager (The Hygenic Corporation, Akron, OH, USA). All procedures were performed exclusively on the right thigh and administered by the same investigator to ensure methodological consistency. The protocol included a total of eight sets, four per muscle group (hamstrings and quadriceps of the right thigh), resulting in an overall intervention duration of 4 minutes (2 minutes allocated to the hamstrings and 2 minutes to the quadriceps). Each muscle group underwent four sets of 30 rolling repetitions executed at a controlled cadence of one repetition per second, yielding 30 seconds of continuous rolling per set. No other drugs or devices were involved in the procedural interventions. Receives: Other: Foam Rolling Intervention (FR) |
| Passive Control Session | No intervention | During the time-matched passive control condition, participants remained in a supine position on a standard medical examination bed for 8 minutes. This duration was matched to the total time required for the FR protocol, thereby ensuring temporal equivalence between conditions. Throughout the period between the T0 and T1 assessments, no active interventions were administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic and diastolic blood pressure were assessed in the supine position using a validated automated oscillometric monitor (Omron MX3 Plus; Omron Healthcare, model HEM-742-E). Mean arterial pressure (MAP) and rate pressure product (RPP) were subsequently derived using conventional formulas.
Measured: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
Secondary outcomes (2)
Heart rate variability
Heart rate variability (HRV) was recorded with participants resting supine on a medical examination table for an additional 5 minutes under quiet and controlled conditions. During this recording phase, beat-to-beat RR intervals were continuously monitored using a validated Polar H10 chest-strap heart rate sensor (Polar Electro Oy, Kempele, Finland). HRV metrics were derived from both time-domain and frequency-domain analyses, providing a comprehensive evaluation of cardiac autonomic modulation.
Measured: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
Tissue Hardness
Tissue hardness (TH) was quantified in Newton using a portable tissue hardness meter (NEUTONE TDM-N1; TRY-ALL Corp., Chiba, Japan). For hamstring evaluation, the ischial tuberosity and the popliteal fossa were used as proximal and distal anatomical reference points, respectively. Two measurement sites were identified within the proximal third of the posterior right thigh: a lateral site corresponding to the biceps femoris and a medial site corresponding to the semitendinosus/semimembranosus complex. Quadriceps TH was assessed using the anterior superior iliac spine (ASIS) as the proximal landmark, and the superior border of the patella as the distal landmark. (1) the midpoint between the ASIS and the superior patellar border, and (2) a point located at the proximal third of the same linear distance.
Measured: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start14 Oct 2025
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewan Thomas, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520474
- Sponsor's protocol ID
- RM-BP 60625-2025
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Blood Pressure Responses to Operator-administered Foam Rolling of the Right Thigh: A Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT07520474
- Acronym / sponsor ID
- RM-BP 60625-2025
- Keywords
- massage roller, cardiovascular health, stiffness, peripheral resistance, heart rate variability, foam rolling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 9 Apr 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.
Foam rolling (FR) has emerged as a widely adopted modality among rehabilitation practitioners and physically active populations. Previous investigations on FR have reported improvements in joint range of motion, small to trivial enhancements in selected performance measures, attenuation of exercise-induced muscle soreness, and reductions in pain perception. While the evidence base supporting range-of-motion, performance, muscle soreness and pain sensitivity adaptations is relatively well developed, considerably less attention has been directed toward the blood pressure responses to FR and the potential underlying mechanisms. Consequently, the physiological impact of FR on cardiovascular regulation in healthy, normotensive young adults remains insufficiently characterized and requires further systematic investigation. An acute reduction in blood pressure may be postulated, potentially mediated by mechanisms involving changes in total peripheral resistance, which could be linked to modifications in tissue mechanical characteristics. In parallel, a contributory role of autonomic regulation cannot be excluded, as shifts in sympathetic and parasympathetic activity may also influence cardiovascular responses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foam Rolling Intervention (FR) | Experimental | Other: Foam Rolling Intervention (FR)The FR intervention was conducted using a Theraband® Roller Massager (The Hygenic Corporation, Akron, OH, USA). All procedures were performed exclusively on the right thigh and administered by the same investigator to ensure methodological consistency. The protocol included a total of eight sets, four per muscle group (hamstrings and quadriceps of the right thigh), resulting in an overall intervention duration of 4 minutes (2 minutes allocated to the hamstrings and 2 minutes to the quadriceps). Each muscle group underwent four sets of 30 rolling repetitions executed at a controlled cadence of one repetition per second, yielding 30 seconds of continuous rolling per set. No other drugs or devices were involved in the procedural interventions. |
| Passive Control Session | No intervention | –During the time-matched passive control condition, participants remained in a supine position on a standard medical examination bed for 8 minutes. This duration was matched to the total time required for the FR protocol, thereby ensuring temporal equivalence between conditions. Throughout the period between the T0 and T1 assessments, no active interventions were administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy, normotensive men and women aged 18 years or older
- female participants were recruited during the follicular phase of their menstrual cycle
Key exclusion criteria (8 listed)
- orthopedic disorders
- neurological disorders
- renal disorders
- metabolic disorders
- musculoskeletal disorders
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 |
|---|---|---|
| Foam Rolling Intervention (FR)The FR intervention was conducted using a Theraband® Roller Massager (The Hygenic Corporation, Akron, OH, USA). All procedures were performed exclusively on the right thigh and administered by the same investigator to ensure methodological consistency. The protocol included a total of eight sets, four per muscle group (hamstrings and quadriceps of the right thigh), resulting in an overall intervention duration of 4 minutes (2 minutes allocated to the hamstrings and 2 minutes to the quadriceps). Each muscle group underwent four sets of 30 rolling repetitions executed at a controlled cadence of one repetition per second, yielding 30 seconds of continuous rolling per set. No other drugs or devices were involved in the procedural interventions. | Other | Foam Rolling Intervention (FR) |
Primary outcome
Blood Pressure
Time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.
Systolic and diastolic blood pressure were assessed in the supine position using a validated automated oscillometric monitor (Omron MX3 Plus; Omron Healthcare, model HEM-742-E). Mean arterial pressure (MAP) and rate pressure product (RPP) were subsequently derived using conventional formulas.
2 secondary outcomes
Heart rate variability
Time frame: - 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.
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 16 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam Rolling Intervention (FR) in people with Healthy Young Adults and Healthy Adult Participants, run by University of Palermo at 1 site in Italy.
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 2 inclusion and 8 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 16 Oct 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 Italy. 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?
Blood Pressure (time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.). 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 16 Oct 2026.