NCT03875170

Brief Summary

Introduction: The loss of normal values of ROM due to the lack of flexibility and strength in the hip flexors, quadriceps and hamstrings in soccer players can cause a loss of mobility of the hip and knee joint. Proprioceptive neuromuscular facilitation is an active-assisted stretching technique used to improve flexibility and therefore the ranges of joint mobility. Aim. To assess the effectiveness of an intervention by proprioceptive neuromuscular facilitation in the improvement of flexibility and strength in the hamstring, hip flexor and quadriceps musculature compared to conventional stretches in football players. Study design. Randomized, multicentric, single-blind clinical study. Methods. The 30 players will be randomly assigned to the study groups: experimental (proprioceptive neuromuscular facilitation and static stretches) and control (static stretches). The treatment will last 6 weeks, with two sessions a week of 5 minutes each. The study variables will be the range of hip mobility (using goniometry), hamstring flexibility (using the EPR test, inclinometer) and the strength of hip flexors, quadriceps and hamstrings (through the RM test). A descriptive statistical analysis will be carried out calculating the main statistical characteristics and after calculating the normality of the sample (test Kolmogorov- Smirnov), the differences between evaluations in each group (t-student test) and the intra- and intersubject effect will be calculated (ANOVA of repeated measures). Expected results. Improved hip mobility, hamstring flexibility and strength in hip flexors, quadriceps and hamstrings muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

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

First Submitted

Initial submission to the registry

March 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

March 10, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

Proprioceptive Neuromuscular FacilitationRange of motionStretchingMuscle strengthRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Change from baseline flexibility of the hamstring muscles after treatment and at month

    The measurement instrument to measure the flexibility of the hamstring muscles is the passive elevation of the straight leg with an inclinometer (model ISOMED, Inc., Portland, OR) to be placed on the tibia (as distal as possible). The physiotherapist will maintain the extension of the knee and the leg will be lifted by the evaluator to a hip flexion, until the subject indicates pain in the hamstring muscles, when the evaluator perceives hip flexion restriction or when a posterior pelvic tilt occurs. The contralateral knee of the subject will remain in extension. The unit of measurement of the test is the maximum angle read from the inclinometer at the point of maximum flexibility, in degrees, with the normative range of 75 to 80 degrees (the greater the degree of flexibility, the greater the flexibility).

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcomes (2)

  • Change from baseline the range of motion of hip after treatment and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Change from baseline strength of upper limbs after treatment and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Proprioceptive neuromuscular facilitation

EXPERIMENTAL

Each session will last 5 minutes for each subject, taking place two sessions a week, in a period of 6 weeks. The intervention will be made at the beginning of the training session. The technique will be carried out with the subjects in the positions of supine, prone and lateral position, for the flexor muscles of the hip, hamstrings and quadriceps, where the musculature and the joint to be treated will be taken to a range of functional mobility

Other: Experimental

Muscle stretching

ACTIVE COMPARATOR

Each session will last 5 minutes for each subject, taking place two sessions a week, in a period of 6 weeks. The intervention will be made at the beginning of the training session. It will be done for the hip, quadriceps and hamstring muscles with a voluntary antagonist activation to relax the agonist muscle.

Other: Control

Interventions

The technique will be carried out with the subjects in the positions of supine, prone and lateral position, for the flexor muscles of the hip, hamstrings and quadriceps, where the musculature and the joint to be treated will be taken to a range of functional mobility. The subject will be asked to perform an isometric contraction, with a series of 3 seconds for sustained contraction and a rest between contraction of 2 to 3 seconds after activating the Golgi apparatus, making an inhibition of the stimulus and bringing the joint and muscle to the highest possible range of motion without pain.

Also known as: Proprioceptive neuromuscular facilitation
Proprioceptive neuromuscular facilitation
ControlOTHER

The active stretching technique will be performed for the hip, quadriceps and hamstring flexors with a voluntary antagonist activation to relax the agonist muscle, holding the movement to be performed for 30 seconds to stimulate the neuromuscular spindle and produce a relaxation of the muscle fibers.

Also known as: Muscle stretching
Muscle stretching

Eligibility Criteria

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

You may qualify if:

  • Volleyball players
  • Male
  • From 18 to 30 years old
  • Federated in the Royal Federation of Football of the Community of Madrid
  • Not had any musculoskeletal injuries in the last 3 months.

You may not qualify if:

  • Impossibility, for work or academic reasons, to comply with the requirements of the study (interventions and evaluations);
  • Under pharmacological treatment
  • Who are exercising a physiotherapy treatment parallel to the development of the study
  • Not sign the informed consent document.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University of Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Somatosensory Disorders

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 14, 2019

Study Start

April 12, 2019

Primary Completion

May 15, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations