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OpenTrials
Completed

NCT Number: NCT07520474

Roller Massage and Blood Pressure

Roller massage (RM), frequently described within the broader framework of self-myofascial release, has emerged as a widely adopted modality among rehabilitation practitioners and physically active populations. Previous investigations on RM 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 mobility, performance, muscle soreness and pain sensitivity adaptations is relatively well developed, considerably less attention has been directed toward the blood pressure responses to RM and the potential underlying mechanisms. Consequently, the physiological impact of RM on cardiovascular regulation 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.

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Key information

Conditions

Healthy Young Adults Healthy Adult Participants Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Palermo

Palermo, Sicily, 90144, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy participants aged 18 years or older.

Exclusion criteria

  • orthopedic disorders
  • neurological disorders
  • renal disorders
  • metabolic disorders
  • musculoskeletal disorders
  • cardiovascular disorders
  • use of antihypertensive medication.

Treatment and study plan

Roller Massage Intervention (RM)

Other

The RM 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, 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 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.

  2. Tissue Hardness

    Time frame: - Day 1: Baseline (upon arrival) and immediately post-intervention; - Day 2: Baseline (upon arrival) and immediately post-intervention.

    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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Association Between Reductions in Tissue Hardness and Acute Decreases in Blood Pressure Following Roller Massage: A Randomized Controlled Crossover Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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