NCT05189652

Brief Summary

In general, the strength training on unstable surfaces has a positive impact on strength performance, power and stability compared to not training. As described above, previous studies have shown that self-myofascial release has a positive effect by improving flexibility, but its effect on balance is still debated. Myofascia contains numerous sensory nerves related to proprioceptive and mechanical receptors such as Golgi receptors or Pacini receptors. Therefore, the pressure applied during the self-myofascial release intervention can stimulate these mechanoreceptors and enhance the proprioceptive information integrated by the central nervous system to adjust the activation level of motor units. The aim of this study is to examine the effects of myofascial release applied to the thoracolumbar fascia on flexibility, muscular endurance and balance in healthy young adults.

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 Jan 2022

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

December 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

December 6, 2021

Last Update Submit

September 29, 2022

Conditions

Outcome Measures

Primary Outcomes (17)

  • Personal informations

    Personal information questionnaire: The gender of the participants will be recorded by the investigator by ticking one of the male/female options. In the data analysis, the gender distribution of the participants will be expressed as a percentage.

    4 weeks

  • Personal informations

    Personal information questionnaire: 'How many years has your education life been?' the survey question will be asked and the length of time in the answer received by asking the question will be recorded by the investigator as the year. In the data analysis, the years of education of the participants will be expressed as the average of years.

    4 weeks

  • Personal informations

    Personal information questionnaire: Profession of the participants, 'Which profession do you do?' the answer received by asking the survey question will be recorded by the investigator. In the data analysis, the professions of the participants will be expressed as a percentage.

    4 weeks

  • Personal informations

    Personal information questionnaire: 'How long have you been doing your profession?' survey question will be asked. The length of time the participants work in the profession will be recorded by the investigator as the year. In the data analysis, the years of working time in profession of the participants will be expressed as the average of years.

    4 weeks

  • Clinical status

    Clinical status questionnaire: The age of the participants is, 'How old are you?' the answers received by asking the survey question will be recorded by the investigator as the year. In the data analysis, the ages of the participants will be expressed as the average of the years.

    4 weeks

  • Clinical status

    Height: Participants' height in cm will be recorded by the investigator.

    4 weeks

  • Clinical status

    Weight: Participants' weight in kg will be recorded by the investigator.

    4 weeks

  • Clinical status

    BMI: Participants' body mass index in kg/m\^2 will be recorded by the investigator.

    4 weeks

  • Clinical status

    Clinical status questionnaire: To identify the participants' dominant lower extremity, when the participants are given the 'Jump on one foot' command, the preferred foot will be marked as the right or left extremity by the investigator. In the data analysis, the dominant extremities of the participants will be expressed as a percentage.

    4 weeks

  • Clinical status

    Clinical status questionnaire: The survey question 'Did you exercised regularly at least 2 days a week during the last 6 months' will be asked to the participants. Yes or no answers will be recorded by the investigator.

    4 weeks

  • Clinical status

    Clinical status questionnaire: In order to determine the smoking habits of the participants, the survey question 'Do you smoke?' will be asked and one of the smoker/non-smoker options will be marked by the investigator. In the data analysis, the smoking of the participants will be expressed as a percentage.

    4 weeks

  • Flexibility measurements

    Sit and Reach Test: A standard sit and reach box will be placed on the floor. Participants will be asked to sit on the floor on a flat surface and rest their bare feet flat on the test bench. Afterwards, participants will be asked to hold for a second or two at the last point, extending their torso forward as far as participants can reach, with the arms and fingers stretched and straight. For data analysis, each measurement will be repeated 2 times by the investigator. A ruler will be used as a measuring tool and the measurement result will be recorded in cm.

    4 weeks

  • Flexibility measurements

    Active Knee Extension Test: Participants will lie in the supine position with the hip joint and knee joint in 90 degrees flexion and the other knee will be kept flat on the ground. The participant will be asked to straighten the knee of the evaluated side as much as possible without disturbing the hip joint angle. At the last possible point, the degree of knee flexion will be measured by the investigator with a goniometer. Each measurement will be repeated 2 times for data analysis.

    4 weeks

  • Muscular endurance measurements

    1 Minute Sit to Stand Test: Participants will get up and sit in a chair without an armrest as many times as possible in 1 minute. The chair will be adjusted so that the angle of the knee joints is approximately 90° while sitting. During the test, participants will be asked to keep feet parallel and hands on waists to avoid using arms to assist with movement. Participants will be instructed to stand up when bringing knees to full extension and to touch the chair with hips while sitting. Participants will be instructed to do as many sit to stand repetitions as possible in 1 minute by the investigator. Participants will be informed with 15 seconds remaining but will not be motivated during the test. The number of complete and correct sit-to-stand cycles after 1 minute will be recorded by the investigator for analysis.

    4 weeks

  • Static Balance

    One-leg Standing Test: The duration of standing by reducing the support surface of the participants and maintaining balance on one leg with eyes open and closed will be recorded by the investigator. A stopwatch will be used as a measurement tool. The time from the moment the participants starts to stand on one leg until he loses his balance will be recorded in seconds. The test will be terminated if the participants can stand on one leg for 60 seconds without losing balance.

    4 weeks

  • Dynamic Balance

    Star Excursion Balance Test: A star shape will be drawn on the ground with a total of 8 directions at an angle of 45 degrees. Participants will be asked to reach these directions according to the predetermined protocol and the distance reached by the participants will be recorded by the investigator in cm. Before the application, the participants will be given a rest period of 180 seconds to familiarize themselves with the test and 120 seconds between applications. In addition, 5 seconds will be given by the researchers between each stretch so that participants can stand on good feet. In order to normalize the data, the leg length of the participants will be measured in cm between spina iliaca anterior superior-medial malleolus and recorded by the investigator. A tape measure will be used as a measuring tool. The measurement results will be recorded by the investigator in cm. Each measurement will be repeated 3 times for data analysis.

    4 weeks

  • Fatigue

    Modified Borg Fatigue Scale: The Modified Borg Scale will be used to assess the level of effort reported by participants during physical exercise. Participants will report perceived fatigue immediately after each exercise session on this scale from zero to ten (0-10). In this way, the intensity of the exercise will be determined.

    4 weeks

Study Arms (3)

Myofascial Release and Exercise Group

EXPERIMENTAL

Foam roller massage will be applied to the thoracolumbar posterior chain for participants in the myofascial release and exercise group. At the same time, balance training, squat exercises, reach forward with sitting and hamstring stretching exercises will be applied to this group for a period of four weeks. Before starting the exercise training programs, a 5 minute warm-up will be done. The first evaluation of the participants will be made before starting the 4-week program. Final assessments will be made within 2-3 days after the 4-week training ends. Evaluations will include flexibility measurements, muscular endurance measurements, balance evaluations.

Other: Myofascial Release and Exercise Group

Exercise Group

EXPERIMENTAL

For the participants in the exercise group, the exercise program (balance training, squat exercises, reach forward with sitting and hamstring stretching exercises) will be applied 3 days a week for 4 weeks without any intervention to the thoracolumbar fascia. Before starting the exercise training programs, a 5 minute warm-up will be done. The first evaluation of the participants will be made before starting the 4-week program. Final assessments will be made within 2-3 days after the 4-week training ends. Evaluations will include flexibility measurements, muscular endurance measurements, balance evaluations.

Other: Exercise Group

Control Group

NO INTERVENTION

Any myofascial release or exercise program will not be applied to the participants in the control group. The first evaluation of the participants will be made before other groups starting the 4-week program. Final assessments will be made within 2-3 days after the other groups 4-week training ends. Evaluations will include flexibility measurements, muscular endurance measurements, balance evaluations.

Interventions

The exercise program will be applied 3 days a week for 4 weeks. Participants will warm up by walking for 5 minutes before exercise. Stretching exercises - Reach forward with sitting and hamstring (3 reps\*30 sec). First 2 weeks: Squat exercise (3 sets of 10 reps). Standing on one leg with knee flexed and hip-knee flexed at 90 degrees (30 seconds). Star Excursion balance training (2 rounds to be applied). Foam Roller massage will apply to thoracolumbar posterior chain (1 set of 30 seconds will be applied with a rolling period of 2-4 seconds). Last 2 weeks: Squat exercise (3 sets of 15 reps). Standing on one leg with knee flexed and hip-knee flexed at 90 degrees (40 seconds). Star Excursion balance training (3 rounds to be applied). Foam Roller massage will apply to thoracolumbar posterior chain (2 sets of 30 seconds will be applied to each area with a rolling period of 2-4 seconds).

Myofascial Release and Exercise Group

The exercise program will be applied 3 days a week for 4 weeks. Participants will warm up by walking for 5 minutes before exercise. Stretching exercises- Reach forward with sitting and hamstring (3 reps\*30 sec). First 2 weeks: Squat exercise (3 sets of 10 reps). Standing on one leg with knee flexed and hip-knee flexed at 90 degrees (30 seconds). Star Excursion balance training (2 rounds to be applied). Last 2 weeks: Squat exercise (3 sets of 15 reps). Standing on one leg with knee flexed and hip-knee flexed at 90 degrees (40 seconds). Star Excursion balance training (3 rounds to be applied).

Exercise Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • be between the ages of 18-40
  • Volunteer

You may not qualify if:

  • To have exercised regularly for the last 6 months
  • Injury to the lower extremity in the last 6 months
  • Having the condition in which the application of myofascial release is contraindicated
  • Orthopedic, neurological, endocrine, vascular, etc. to prevent exercise structure having diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hasan Atacan Tonak, Asst. Prof. Dr.

    Akdeniz University

    PRINCIPAL INVESTIGATOR
  • Hatice Ozdemir, PT

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 6, 2021

First Posted

January 12, 2022

Study Start

January 24, 2022

Primary Completion

April 22, 2022

Study Completion

May 24, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations