NCT07520474

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

massage rollercardiovascular healthstiffnessperipheral resistanceheart rate variability

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (2)

  • Heart rate variability

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

  • Tissue Hardness

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

Study Arms (2)

Roller Massage Intervention (RM)

EXPERIMENTAL

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.

Other: Roller Massage Intervention (RM)

Passive Control Session

NO INTERVENTION

During the 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 RM protocol, thereby ensuring temporal equivalence between conditions. Throughout the period between the T0 and T1 assessments, no active interventions were administered.

Interventions

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.

Roller Massage Intervention (RM)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy participants aged 18 years or older.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, Sicily, 90144, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ewan Thomas - Associate Professor, Department of Psychology, Educational Science, and Human Movement

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

May 12, 2025

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations