NCT07078448

Brief Summary

The hamstring muscle, as a biarticular muscle, plays a crucial role in both hip extension and knee flexion and is part of the Superficial Back Line, which supports upright posture and prevents excessive flexion. Its continuous postural function requires endurance-oriented muscle fibers and sustained low-level muscle tone. Tightness in the hamstrings is commonly linked to postural imbalances and structural factors, contributing to gait alterations, low back pain, tendinopathy, and other musculoskeletal disorders. Improving hamstring flexibility is important for performance and injury prevention, with myofascial release-particularly self-myofascial release using foam rollers-being an effective method. Foam rolling reduces muscle tension, enhances tissue hydration, and may alleviate fascial adhesions. However, sex differences exist in connective tissue properties, potentially influencing outcomes. Limited research has explored foam rolling's impact on peripheral muscle oxygenation. This study aims to investigate the effect of foam rolling on hamstring muscle oxygen saturation in recreational individuals with tightness, with a hypothesis that females may show greater increases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

June 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

July 14, 2025

Last Update Submit

September 19, 2025

Conditions

Keywords

MoxyMyofascial Releasehamstring shortnessNear-Infrared Spectroscopyrange of motion

Outcome Measures

Primary Outcomes (1)

  • Muscle Oxygenation Assessment

    Muscle oxygenation will be assessed using the MOXY Monitor, a portable, wireless, near-infrared spectroscopy (NIRS)-based device. The monitor will be placed on the belly of the right biceps femoris muscle and secured with an opaque elastic band to prevent ambient light interference. Measurements will be taken five minutes before and five minutes after the intervention session. During each measurement, the device will record data for 60 seconds, and the average SmO₂ (muscle oxygen saturation) value over this period will be used for analysis.

    baseline, immediately after the intervention, ten minutes after the baseline

Secondary Outcomes (1)

  • Active Knee Extension (AKE) Test

    baseline, immediately after the intervention, ten minutes after the baseline

Study Arms (2)

female

EXPERIMENTAL

foam roller intervention

Other: Foam Roller

male

EXPERIMENTAL

foam roller intervention as the females received

Other: Foam Roller

Interventions

FR will be applied to each hamstring muscle for 3 minutes per leg, totaling 6 minutes. The pressure was self-regulated by participants, who are instructed to apply as much body weight as tolerable. The rolling frequency is maintained at approximately 0.5 Hz, corresponding to one complete rolling cycle every 2 seconds. Before the intervention, participants will receive verbal and visual instructions to ensure correct execution.

femalemale

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsNo, gender identity did not differ from biological sex in any participant; therefore, eligibility was based on biological sex.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals aged between 18 and 35 years
  • Both male and female participants
  • Absence of any known health conditions
  • Hamstring tightness defined as ≥20° of knee flexion angle in Active Knee Extension test

You may not qualify if:

  • Any neuromuscular or orthopedic disorders affecting the lower extremities
  • Circulatory or vascular problems
  • Respiratory or cardiovascular diseases
  • Renal failure
  • Presence of pain during measurements or exercise protocols
  • Excessive skin sensitivity or active skin infection
  • History of intense physical activity within the last 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçeşehir University

Istanbul, Beşiktaş, 34353, Turkey (Türkiye)

Location

Study Officials

  • Gökhan Koçak, MD

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Pelin Pişirici, PT, PhD

    Bahcesehir University, Faculty of Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants who met the inclusion criteria were divided into two groups according to sex (female and male). Each group received the same foam roller intervention. Hamstring muscle oxygenation and joint range of motion were measured before the intervention, immediately after, and ten minutes post-intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 22, 2025

Study Start

June 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations