NCT06411782

Brief Summary

The aim of this study is to examine the acute effect of the foam roller (FR) method applied to the sternocleidomastoid (SCM) muscle after respiratory muscle fatigue on joint range of motion (ROM), accessory respiratory muscle activity and muscle strength. The aim of this study is to examine the changes in fatigue and pain symptoms by applying relaxation on the tense fascia and shortened muscle as a result of resistance training, and the effect of these changes in the sternocleidomastoid (SCM) muscle on joint range of motion (ROM) and muscle strength in healthy male or female participants aged 18-30. In line with the investigators' results, it may be recommended to add foam roller (FR) to the accessory respiratory muscles in the pulmonary rehabilitation program in patients with chronic lung diseases. For this reason, the investigators think that it will provide clinical and scientific benefits. The investigators believe that it will lead studies to add foam roller (FR) to the pulmonary rehabilitation program in patients with chronic lung diseases. Participants will be informed about the risks and benefits of participating in the study and a voluntary consent form will be signed. Participants will be given a demographic data form before starting the study and will be asked to fill it out. The hypermobility value will be measured according to the Beighton score before the participants start the tests. After the inspiratory muscle training (IMT) study, foam roller (FR) will be applied to the right sternocleidomastoid (SCM) muscle. A one week washout period will be given. Afterwards, the cases will be applied foam roller (FR) to the left sternocleidomastoid (SCM) muscle after the inspiratory muscle training (IMT) study. All evaluation parameters will be repeated before and after the applications. Maximum inspiratory pressure measurement, range of motion (ROM) measurements, muscle strength tests, flexibility with a myotony measuring device, electromyography (EMG) measurements will be made before the study one by one.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

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

May 4, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

May 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

May 4, 2024

Last Update Submit

October 17, 2024

Conditions

Keywords

Foam RollerSternocleidomastoid MuscleInspiratory Muscle TrainingMIP

Outcome Measures

Primary Outcomes (2)

  • Muscle Stiffness and Muscle Tone of sternocleidomastoid muscle

    Elasticity measurement will be evaluated with the MyotonPro brand device. Measurements will be made while the subjects are in the sitting position. Primarily, marking will be made between the adhesion site of the sternocleidomastoid (SCM) to the anterior surface of the manubrium sterni and the adhesion on the mastoid process of the temporal bone. Then the measurement will be made. The probe of the device (3 mm diameter) will be placed perpendicular to the skin surface with a constant preload (0.18 N).

    1 Hour

  • Electromyographic activity level measurement of sternocleidomastoid muscle

    Trigno Avanti brand surface electromyography (EMG) measurement sensors will be used to record the superficial EMG signals. The skin area will be cleaned with alcohol. Contraction of the sternocleidomastoid (SCM) muscle will be achieved by performing SCM neck flexion movement and electrode placement will be determined by palpating the muscle midpoint. During the initial evaluation, after the inspiratory muscle training (IMT) study and after the foam roller (FR) application, measurements will be made from both SCM muscles.

    During the intervention

Secondary Outcomes (3)

  • Sternocleidomastoid Muscle Strength Measurements

    1 Hour

  • Cervical joint range of motion

    1 Hour

  • Maximum Inspiratory Pressure Measurement

    1 Hour

Study Arms (2)

Foam Roller Group

EXPERIMENTAL

Inspiratory muscle training will be done with a resistive exercise device at 80% of MIP max and for 30 breaths. After training, foam roller application will be applied to the right sternocloideomastoid muscle.

Device: Foam rollerDevice: Inspiratory muscle training

Non Foam Roller Group

EXPERIMENTAL

Inspiratory muscle training will be done with a resistive exercise device at 80% of MIP max and for 30 breaths. Foam roller application will not be done.

Device: Inspiratory muscle training

Interventions

In foam roller application, a partitioned FR from the Trigger Point Grid 2.0 brand, measuring 33x14 cm and weighing 0.9 kg, with an inner part made of polyvinylchloride (PVC), will be used. Participants will roll the segmented FR with slight flexion-extension by placing the FR on the SCM muscle to apply FR from the starting point to the end point of that muscle region for the selected SCM muscle, with the person in the side stance position against the wall. This action will consist of 3 sets of 1 minute each, with a 30-second rest period between each set. It will be applied once for each region, including the right and left SCM muscle.

Foam Roller Group

Inspiratory muscle training will be done with a resistive exercise device at 80% of MIP max and for 30 breaths.

Foam Roller GroupNon Foam Roller Group

Eligibility Criteria

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

You may qualify if:

  • Healthy Adults
  • Not exercising regularly for the last 6 months
  • To have participated in the study voluntarily
  • Individuals without widespread visceral or musculoskeletal pain were included.

You may not qualify if:

  • Using pain medication
  • Soft tissue, muscle and bone injury
  • Spinal cord or upper extremity injuries
  • Fibromyalgia
  • Cases treated with myofascial release
  • Individuals who did not have hypermobility according to the Beighton score were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Istanbul, 34668, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a cross-controlled study. Inspiratory muscle training (IMT) training will be performed on the subjects, and then FR will be applied to the Right SCM muscle. A 1 week purification period will be given. Later, after the IMT study, FR will be applied to the Left SCM muscle. All evaluation parameters will be repeated before and after the applications.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 13, 2024

Study Start

May 12, 2024

Primary Completion

October 17, 2024

Study Completion

October 17, 2024

Last Updated

October 21, 2024

Record last verified: 2024-10

Locations