NCT06240013

Brief Summary

The hamstring muscle is one of the key elements in rehabilitation programs and sports activities that enable the restoration of optimal muscle length. Decreased flexibility in the hamstring muscle may disrupt the biomechanics of the waist and pelvis, leading to low back pain or musculoskeletal disorders. This study aims to investigate the acute effects of foam rolling and proprioceptive neuromuscular facilitation stretching during warm-up on muscle flexibility, strength, and pain threshold in amateur athletes. According to our research, there is no study in this field in the literature. H1: There is a difference between the acute effects of foam rolling exercise and PNF stretching exercise on muscle flexibility during warm-up in amateur athletes. H2: There is a difference between the effects of foam rolling and PNF stretching exercises used as warm-up exercises on muscle strength. H3: Foam rolling and PNF stretching exercises applied to the Hamstring muscle as a warm-up exercise make a difference in the pain threshold of the lumbar region and Hamstring muscle.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

January 12, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

Muscle Stretching ExercisesPain ThresholdRange of Motion, ArticularMuscle Strength

Outcome Measures

Primary Outcomes (3)

  • Hamstring Flexibility

    Hamstring flexibility (mm) will be evaluated with the sit-reach test. Baseline® Sit and Reach Flexibility Measurement device will be used for testing. Participants will sit on the floor with their lower extremities extended and together; Their backs and hips will be supported against the wall, and the soles of their feet will be placed on the edge of the device. Participants will then extend their arms forward, with both hands facing down and one hand on top of the other (always the same hand on top). Participants will then be asked to lie forward and slide their hands as far as possible on the measurement scale without bending their knees. Measurements will be repeated three times and the average value will be recorded.

    Pre-intervention and immediately after the intervention

  • Hamstring Muscle Strength

    Strength measurement of the participants' Hamstring muscles will be made using a digital hand dynamometer (J Tech Commender Muscle Tester). Participants will be instructed to sit in a fairly upright position in a chair, with their arms crossed in front of their chest and their legs hanging over the edge, with their knees and hips flexed at 90°. For isometric knee flexion muscle measurement evaluation, the dynamometer will be placed in the sural triceps region (5 cm proximal to the lateral malleolus). Participants press the dynamometer as hard as possible for three seconds, while the assessor will provide resistance, preventing any movement to achieve an isometric contraction.

    Pre-intervention and immediately after the intervention

  • Pain Threshold

    An algometer (Dolorimeter) will be used to objectively measure pain threshold and pain tolerance. The pain threshold value due to the pressure to be applied to the hamstring muscle and waist area will be measured using an electronic algometer (Algometer, Baseline FDK 10) while the athlete is in a prone position on the bed. The algometer will be applied vertically to the most painful point, increasing the pressure by 1kg/cm2 every three seconds until the patient feels pain. The pressure value that causes the feeling of pain will be determined as the pain threshold.

    Pre-intervention and immediately after the intervention

Secondary Outcomes (1)

  • Lower Extremity Muscle Strength

    Pre-intervention and immediately after the intervention

Study Arms (2)

Group 1 Training Program

EXPERIMENTAL

5 minutes of light aerobic cycling, unilateral 2\*60 sec on dominant leg - 2 min foam rolling training in total

Other: Foam Rolling

Group 2 Training Program

EXPERIMENTAL

5 minutes of light aerobic cycling, unilateral 4\*30 seconds on the dominant leg - 2 minutes in total proprioceptive neuromuscular facilitation stretching training

Other: Proprioceptive Neuromuscular Facilitation Stretching

Interventions

Participants will take a long sitting position on a solid and flat surface, positioning their arms back and transferring their body weight to their palms. The foam roller to be applied to the dominant side will be placed under the hamstrings and slowly moved back and forth from the ischial tuberosity to the popliteal fossa, applying pressure for 2 minutes.

Group 1 Training Program

A PNF stretching protocol will be implemented with each participant assuming a tall sitting position on a solid, flat surface with their knees extended as much as possible. At this moment, the participant will be asked to perform maximum isometric hamstring muscle contraction for 5 seconds, followed by 5 seconds of relaxation and 20 seconds of stretching.

Group 2 Training Program

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-30
  • Being an amateur athlete

You may not qualify if:

  • Hypermobility
  • History of hamstring injury in the last 6 months
  • Diagnosed orthopedic problems
  • Surgery in the lower extremity or spine
  • Back pain
  • Presence of systemic or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, None Selected, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elif E Safran, asst. prof.

    Acibadem University

    STUDY DIRECTOR
  • Hayri E Yılmaz

    Acibadem University

    PRINCIPAL INVESTIGATOR
  • Birce B Çelik

    Acibadem University

    STUDY CHAIR
  • Mahmut E Bükülmez

    Acibadem University

    STUDY CHAIR
  • Eren Çekiç

    Acibadem University

    STUDY CHAIR

Central Study Contacts

Elif E Safran, asst. prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 2, 2024

Study Start

April 16, 2024

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations