Muscle SorenessNCT05276986

Effects of Delayed Muscle Pain on Respiratory Muscle Function

A study testing DOMS protocol in people with Muscle Soreness and Exercise, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study was to determine whether delayed-onset muscle soreness (DOMS) in trunk muscles has an effect on respiratory function parameters, respiratory muscle strength, respiratory muscle endurance, and exercise capacity. Read more about this study

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Muscle Soreness, Exercise, Respiratory Muscles
What is being tested?: DOMS protocol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesTurkey (Türkiye)
Study dates: 17 Nov 2019to 12 Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Being a healthy individual between the ages of 18-25
Not having a regular exercise habit
No infection until at least 3 weeks before the study

Who cannot join

Lung disease
Cardiovascular disease
Neurological disease
Orthopedic disease

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Ankara
Faculty of Health Sciences, Departmant of Physiotherapy and Rehabilitation, Baskent University
Ankara

Other trials in Turkey (Türkiye)

About this study

Read the detailed description

In 24 healthy university students was induced for the trunk muscles with a load equals to 80% of the maximum repetitive voluntary contraction. Pulmonary function parameters, respiratory muscle strength and endurance, exercise capacity, pain, fatigue, and dyspnea perception severity were recorded before DOMS and at the 24th and 48th hours after DOMS.

After DOMS, there is a decrease in respiratory performance values and exercise capacity of healthy individuals and athletes. Therefore, it should be taken into account that delayed muscle soreness before the competition may affect performance. It may be beneficial to take precautions for delayed muscle pain while creating training and exercise programs, and to create treatment programs in case of the emergence of DOMS.

Conditions: Muscle Soreness, Exercise, Respiratory Muscles, Respiratory Function Tests
Being tested: DOMS protocol
Keywords: Muscle Soreness, Exercise, Respiratory Muscles, Respiratory Function Tests
Medical subject headings: Myalgia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DOMS protocolOther
For a maximum repetition of the trunk muscles, two measurements were made with a 45-second rest interval.The values were recorded in Newtons by taking the maximum value of the two repetitions measured. DOMS was formed by eccentric contraction with 80% of this determined value.To generate DOMS in the trunk, participants were seated on the bench with the knees flexed at 90° and the soles of the feet in full contact with the floor, keeping the weight at 80% of the predetermined maximum repetition.The participants were asked to perform trunk extension with eccentric contraction of the trunk in 5 seconds, and trunk flexion with concentric contraction in 3 seconds.Two-minute rests between sets and 45-second rests between repetitions were given.The date and time of the created DOMS were recorded and the measurements were repeated at the 24th and 48th hours.

Study groups in NCT05276986
Study group	Role	What they receive
DOMS protocol group	Experimental	DOMS was induced for the trunk muscles with a load equals to 80% of the maximum repetitive voluntary contraction. Pulmonary function parameters, respiratory muscle strength and endurance, exercise capacity, pain, fatigue, and dyspnea perception severity were recorded before DOMS and at the 24th and 48th hours after DOMS. Receives: Other: DOMS protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulmonary Function Tests (FVC)
Forced vital capacity (FVC) was evaluated. The volume of air that is exhaled quickly and strongly following a deep inspiration. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Measured: Pulmonary function test measurements were made in all individuals at baseline.
Pulmonary Function Tests (FEV1)
Forced expiratory volume in the first second (FEV1) was evaluated. It is the volume of air expelled in the first second from the start of the forced vital capacity maneuver. It gives information about the restriction on major airlines in general.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Measured: Pulmonary function test measurements were made in all individuals at baseline.
Pulmonary Function Tests (FEF25%-75%)
Flow rate value of forced expiratory volume (FEF25%-75%) was evaluated. It is the mean flow rate in 50% of the forced vital capacity maneuver. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Measured: Pulmonary function test measurements were made in all individuals at baseline.
Pulmonary Function Tests (VC)
Vital capacity (VC) was evaluated. It is the volume of air in the lungs that varies between full inspiration and maximum expiration. It is possible to measure the volume of both a slow and vigorous exhalation after a deep inspiration.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Measured: Pulmonary function test measurements were made in all individuals at baseline.
Pulmonary Function Tests (FVC)
Forced vital capacity (FVC) was evaluated. The volume of air that is exhaled quickly and strongly following a deep inspiration. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Measured: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Pulmonary Function Tests (FEV1)
Forced expiratory volume in the first second (FEV1) was evaluated. It is the volume of air expelled in the first second from the start of the forced vital capacity maneuver. It gives information about the restriction on major airlines in general.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Measured: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Pulmonary Function Tests (FEF25%-75%)
Flow rate value of forced expiratory volume (FEF25%-75%) was evaluated. It is the mean flow rate in 50% of the forced vital capacity maneuver. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Measured: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Pulmonary Function Tests (VC)
Vital capacity (VC) was evaluated. It is the volume of air in the lungs that varies between full inspiration and maximum expiration. It is possible to measure the volume of both a slow and vigorous exhalation after a deep inspiration.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Measured: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Pulmonary Function Tests (FVC)
Forced vital capacity (FVC) was evaluated. The volume of air that is exhaled quickly and strongly following a deep inspiration. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Measured: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Pulmonary Function Tests (FEV1)
Forced expiratory volume in the first second (FEV1) was evaluated. It is the volume of air expelled in the first second from the start of the forced vital capacity maneuver. It gives information about the restriction on major airlines in general.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Measured: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Pulmonary Function Tests (FEF25%-75%)
Flow rate value of forced expiratory volume (FEF25%-75%) was evaluated. It is the mean flow rate in 50% of the forced vital capacity maneuver. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Measured: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Pulmonary Function Tests (VC)
Vital capacity (VC) was evaluated. It is the volume of air in the lungs that varies between full inspiration and maximum expiration. It is possible to measure the volume of both a slow and vigorous exhalation after a deep inspiration.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Measured: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Respiratory Muscle Strength Measurement
Respiratory muscle strength validity and reliability were demonstrated by measuring maximal inspiratory (MIP) and maximal expiratory (MEP) pressures with a portable intraoral pressure measuring device (MicroRPM Respiratory Muscle Testing, Germany). Measurements were made using a clamp that prevents nasal breathing and were performed 5 times until a difference of 5 cmH2O remained, with a 30-second rest period between measurements to record the best value, and the best result was recorded in cmH2O. The recorded values were calculated and recorded with the expected values according to age and gender.
Measured: This test was carried out at baseline.
Respiratory Muscle Strength Measurement
Respiratory muscle strength validity and reliability were demonstrated by measuring maximal inspiratory (MIP) and maximal expiratory (MEP) pressures with a portable intraoral pressure measuring device (MicroRPM Respiratory Muscle Testing, Germany). Measurements were made using a clamp that prevents nasal breathing and were performed 5 times until a difference of 5 cmH2O remained, with a 30-second rest period between measurements to record the best value, and the best result was recorded in cmH2O. The recorded values were calculated and recorded with the expected values according to age and gender.
Measured: This test was carried out at the 24th after DOMS.
Respiratory Muscle Strength Measurement
Respiratory muscle strength validity and reliability were demonstrated by measuring maximal inspiratory (MIP) and maximal expiratory (MEP) pressures with a portable intraoral pressure measuring device (MicroRPM Respiratory Muscle Testing, Germany). Measurements were made using a clamp that prevents nasal breathing and were performed 5 times until a difference of 5 cmH2O remained, with a 30-second rest period between measurements to record the best value, and the best result was recorded in cmH2O. The recorded values were calculated and recorded with the expected values according to age and gender.
Measured: This test was carried out at 48th hours after DOMS.
Respiratory Muscle Endurance Test
Respiratory muscle endurance was evaluated with a threshold-loaded (constant) respiratory muscle trainer (Power Breathe®, POWERbreathe International Ltd. Warwickshire, England) with proven validity and reliability . In the evaluation, measurements were made in the upright sitting position in the chair while the nose of the individuals was closed with a clip.
Initial workload was applied at 60% of the maximal inspiratory pressure. Participants were asked to continue inspiring despite constant inspiratory workload.
The respiratory muscle endurance value was obtained by multiplying the maximum workload of the test that can be sustained for at least one minute.
Individuals were told that the test could be terminated if severe fatigue and extreme shortness of breath were experienced during the test.
The results of the test were recorded.
Measured: This test was performed at baseline.
Respiratory Muscle Endurance Test
Respiratory muscle endurance was evaluated with a threshold-loaded (constant) respiratory muscle trainer (Power Breathe®, POWERbreathe International Ltd. Warwickshire, England) with proven validity and reliability . In the evaluation, measurements were made in the upright sitting position in the chair while the nose of the individuals was closed with a clip.
Initial workload was applied at 60% of the maximal inspiratory pressure. Participants were asked to continue inspiring despite constant inspiratory workload.
The respiratory muscle endurance value was obtained by multiplying the maximum workload of the test that can be sustained for at least one minute.
Individuals were told that the test could be terminated if severe fatigue and extreme shortness of breath were experienced during the test.
The results of the test were recorded.
Measured: This test was performed at 24 hours after DOMS.
Respiratory Muscle Endurance Test
Respiratory muscle endurance was evaluated with a threshold-loaded (constant) respiratory muscle trainer (Power Breathe®, POWERbreathe International Ltd. Warwickshire, England) with proven validity and reliability . In the evaluation, measurements were made in the upright sitting position in the chair while the nose of the individuals was closed with a clip.
Initial workload was applied at 60% of the maximal inspiratory pressure. Participants were asked to continue inspiring despite constant inspiratory workload.
The respiratory muscle endurance value was obtained by multiplying the maximum workload of the test that can be sustained for at least one minute.
Individuals were told that the test could be terminated if severe fatigue and extreme shortness of breath were experienced during the test.
The results of the test were recorded.
Measured: This test was performed at 48 hours after DOMS.
Exercise Capacity
The exercise capacity of the individuals was evaluated with the 6-Minute Walk Test (6 MWT), a submaximal test with high validity and reliability (ICC=0.94). 6MWT, made according to the American Thoracic Society guidlines.The distance covered in a 6-minute walk was calculated from the number of laps and meters. Values were recorded as a percentage of expected values for age and sex.
Measured: This test was carried out at baseline.
Exercise Capacity
The exercise capacity of the individuals was evaluated with the 6-Minute Walk Test (6 MWT), a submaximal test with high validity and reliability (ICC=0.94). 6MWT, made according to the American Thoracic Society guidlines.The distance covered in a 6-minute walk was calculated from the number of laps and meters. Values were recorded as a percentage of expected values for age and sex.
Measured: This test was carried out at the 24th hours after DOMS.
Exercise Capacity
The exercise capacity of the individuals was evaluated with the 6-Minute Walk Test (6 MWT), a submaximal test with high validity and reliability (ICC=0.94). 6MWT, made according to the American Thoracic Society guidlines.The distance covered in a 6-minute walk was calculated from the number of laps and meters. Values were recorded as a percentage of expected values for age and sex.
Measured: This test was carried out at 48th hours after DOMS.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201912 Jan 2020

First posted14 Mar 2022
Study start17 Nov 2019
Primary completion12 Jan 2020
Study completion12 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Muscle SorenessStudies of the same condition, open and under way.
More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Model description: 24 healthy university students (n=11 female, n=13 male) with a mean age of 21±2 years included the study.
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05276986
Sponsor's protocol ID: 10.01.2022
Status last verified: Jan 2022
First submitted: 12 Jan 2022
Last updated: 14 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Benditt JO. Respiratory Care of Patients With Neuromuscular Disease. Respir Care. 2019 Jun;64(6):679-688. doi: 10.4187/respcare.06827.
PubMed 31110036
Lieber RL, Friden J. Morphologic and mechanical basis of delayed-onset muscle soreness. J Am Acad Orthop Surg. 2002 Jan-Feb;10(1):67-73.
PubMed 11809052
Imtiyaz S, Veqar Z, Shareef MY. To Compare the Effect of Vibration Therapy and Massage in Prevention of Delayed Onset Muscle Soreness (DOMS). J Clin Diagn Res. 2014 Jan;8(1):133-6. doi: 10.7860/JCDR/2014/7294.3971. Epub 2014 Jan 12.
PubMed 24596744
Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
PubMed 12617692
Jamurtas AZ, Theocharis V, Tofas T, Tsiokanos A, Yfanti C, Paschalis V, Koutedakis Y, Nosaka K. Comparison between leg and arm eccentric exercises of the same relative intensity on indices of muscle damage. Eur J Appl Physiol. 2005 Oct;95(2-3):179-85. doi: 10.1007/s00421-005-1345-0. Epub 2005 Jul 9.
PubMed 16007451
Hotta N, Yamamoto K, Katayama K, Ishida K. The respiratory response to passive and active arm movements is enhanced in delayed onset muscle soreness. Eur J Appl Physiol. 2009 Feb;105(3):483-91. doi: 10.1007/s00421-008-0926-0. Epub 2008 Nov 15.
PubMed 19015869
Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.
PubMed 5772056

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Delayed Muscle Pain on Respiratory Muscle Function
ClinicalTrials.gov ID: NCT05276986
Acronym / sponsor ID: 10.01.2022
Conditions: Muscle Soreness, Exercise, Respiratory Muscles, Respiratory Function Tests
Keywords: Muscle Soreness, Exercise, Respiratory Muscles, Respiratory Function Tests
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
Study start: 17 Nov 2019 (actual)
Primary completion: 12 Jan 2020 (actual)
Study completion: 12 Jan 2020 (actual)
First posted: 14 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 24 healthy university students (n=11 female, n=13 male) with a mean age of 21±2 years included the study.

Arm	Type	Receives
DOMS protocol group	Experimental	Other: DOMS protocolDOMS was induced for the trunk muscles with a load equals to 80% of the maximum repetitive voluntary contraction. Pulmonary function parameters, respiratory muscle strength and endurance, exercise capacity, pain, fatigue, and dyspnea perception severity were recorded before DOMS and at the 24th and 48th hours after DOMS.

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Being a healthy individual between the ages of 18-25
Not having a regular exercise habit
No infection until at least 3 weeks before the study

Key exclusion criteria (4 listed)

Lung disease
Cardiovascular disease
Neurological disease
Orthopedic disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DOMS protocolFor a maximum repetition of the trunk muscles, two measurements were made with a 45-second rest interval.The values were recorded in Newtons by taking the maximum value of the two repetitions measured. DOMS was formed by eccentric contraction with 80% of this determined value.To generate DOMS in the trunk, participants were seated on the bench with the knees flexed at 90° and the soles of the feet in full contact with the floor, keeping the weight at 80% of the predetermined maximum repetition.The participants were asked to perform trunk extension with eccentric contraction of the trunk in 5 seconds, and trunk flexion with concentric contraction in 3 seconds.Two-minute rests between sets and 45-second rests between repetitions were given.The date and time of the created DOMS were recorded and the measurements were repeated at the 24th and 48th hours.	Other	DOMS protocol group

Primary outcome

Pulmonary Function Tests (FVC)
Time frame: Pulmonary function test measurements were made in all individuals at baseline.
Forced vital capacity (FVC) was evaluated. The volume of air that is exhaled quickly and strongly following a deep inspiration. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Pulmonary Function Tests (FEV1)
Time frame: Pulmonary function test measurements were made in all individuals at baseline.
Forced expiratory volume in the first second (FEV1) was evaluated. It is the volume of air expelled in the first second from the start of the forced vital capacity maneuver. It gives information about the restriction on major airlines in general.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Pulmonary Function Tests (FEF25%-75%)
Time frame: Pulmonary function test measurements were made in all individuals at baseline.
Flow rate value of forced expiratory volume (FEF25%-75%) was evaluated. It is the mean flow rate in 50% of the forced vital capacity maneuver. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Pulmonary Function Tests (VC)
Time frame: Pulmonary function test measurements were made in all individuals at baseline.
Vital capacity (VC) was evaluated. It is the volume of air in the lungs that varies between full inspiration and maximum expiration. It is possible to measure the volume of both a slow and vigorous exhalation after a deep inspiration.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Pulmonary Function Tests (FVC)
Time frame: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Forced vital capacity (FVC) was evaluated. The volume of air that is exhaled quickly and strongly following a deep inspiration. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Pulmonary Function Tests (FEV1)
Time frame: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Forced expiratory volume in the first second (FEV1) was evaluated. It is the volume of air expelled in the first second from the start of the forced vital capacity maneuver. It gives information about the restriction on major airlines in general.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Pulmonary Function Tests (FEF25%-75%)
Time frame: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Flow rate value of forced expiratory volume (FEF25%-75%) was evaluated. It is the mean flow rate in 50% of the forced vital capacity maneuver. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Pulmonary Function Tests (VC)
Time frame: Pulmonary function test measurements were made in all individuals at the 24th hours after the trunk-oriented DOMS.
Vital capacity (VC) was evaluated. It is the volume of air in the lungs that varies between full inspiration and maximum expiration. It is possible to measure the volume of both a slow and vigorous exhalation after a deep inspiration.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Pulmonary Function Tests (FVC)
Time frame: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Forced vital capacity (FVC) was evaluated. The volume of air that is exhaled quickly and strongly following a deep inspiration. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Pulmonary Function Tests (FEV1)
Time frame: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Forced expiratory volume in the first second (FEV1) was evaluated. It is the volume of air expelled in the first second from the start of the forced vital capacity maneuver. It gives information about the restriction on major airlines in general.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Pulmonary Function Tests (FEF25%-75%)
Time frame: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Flow rate value of forced expiratory volume (FEF25%-75%) was evaluated. It is the mean flow rate in 50% of the forced vital capacity maneuver. Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used. Individuals were asked to make a forced expiration after maximum inspiration.
Pulmonary Function Tests (VC)
Time frame: Pulmonary function test measurements were made in all individuals at the 48th hours after the trunk-oriented DOMS.
Vital capacity (VC) was evaluated. It is the volume of air in the lungs that varies between full inspiration and maximum expiration. It is possible to measure the volume of both a slow and vigorous exhalation after a deep inspiration.Test were performed using a portable spirometer (MIR Spirolab III srl, Italy). During the test, the subject was in a sitting position and their nose was clamped. The test were repeated three times and the best measurement value was used.
Respiratory Muscle Strength Measurement
Time frame: This test was carried out at baseline.
Respiratory muscle strength validity and reliability were demonstrated by measuring maximal inspiratory (MIP) and maximal expiratory (MEP) pressures with a portable intraoral pressure measuring device (MicroRPM Respiratory Muscle Testing, Germany). Measurements were made using a clamp that prevents nasal breathing and were performed 5 times until a difference of 5 cmH2O remained, with a 30-second rest period between measurements to record the best value, and the best result was recorded in cmH2O. The recorded values were calculated and recorded with the expected values according to age and gender.
Respiratory Muscle Strength Measurement
Time frame: This test was carried out at the 24th after DOMS.
Respiratory muscle strength validity and reliability were demonstrated by measuring maximal inspiratory (MIP) and maximal expiratory (MEP) pressures with a portable intraoral pressure measuring device (MicroRPM Respiratory Muscle Testing, Germany). Measurements were made using a clamp that prevents nasal breathing and were performed 5 times until a difference of 5 cmH2O remained, with a 30-second rest period between measurements to record the best value, and the best result was recorded in cmH2O. The recorded values were calculated and recorded with the expected values according to age and gender.
Respiratory Muscle Strength Measurement
Time frame: This test was carried out at 48th hours after DOMS.
Respiratory muscle strength validity and reliability were demonstrated by measuring maximal inspiratory (MIP) and maximal expiratory (MEP) pressures with a portable intraoral pressure measuring device (MicroRPM Respiratory Muscle Testing, Germany). Measurements were made using a clamp that prevents nasal breathing and were performed 5 times until a difference of 5 cmH2O remained, with a 30-second rest period between measurements to record the best value, and the best result was recorded in cmH2O. The recorded values were calculated and recorded with the expected values according to age and gender.
Respiratory Muscle Endurance Test
Time frame: This test was performed at baseline.
Respiratory muscle endurance was evaluated with a threshold-loaded (constant) respiratory muscle trainer (Power Breathe®, POWERbreathe International Ltd. Warwickshire, England) with proven validity and reliability . In the evaluation, measurements were made in the upright sitting position in the chair while the nose of the individuals was closed with a clip. Initial workload was applied at 60% of the maximal inspiratory pressure. Participants were asked to continue inspiring despite constant inspiratory workload. The respiratory muscle endurance value was obtained by multiplying the maximum workload of the test that can be sustained for at least one minute. Individuals were told that the test could be terminated if severe fatigue and extreme shortness of breath were experienced during the test. The results of the test were recorded.
Respiratory Muscle Endurance Test
Time frame: This test was performed at 24 hours after DOMS.
Respiratory muscle endurance was evaluated with a threshold-loaded (constant) respiratory muscle trainer (Power Breathe®, POWERbreathe International Ltd. Warwickshire, England) with proven validity and reliability . In the evaluation, measurements were made in the upright sitting position in the chair while the nose of the individuals was closed with a clip. Initial workload was applied at 60% of the maximal inspiratory pressure. Participants were asked to continue inspiring despite constant inspiratory workload. The respiratory muscle endurance value was obtained by multiplying the maximum workload of the test that can be sustained for at least one minute. Individuals were told that the test could be terminated if severe fatigue and extreme shortness of breath were experienced during the test. The results of the test were recorded.
Respiratory Muscle Endurance Test
Time frame: This test was performed at 48 hours after DOMS.
Respiratory muscle endurance was evaluated with a threshold-loaded (constant) respiratory muscle trainer (Power Breathe®, POWERbreathe International Ltd. Warwickshire, England) with proven validity and reliability . In the evaluation, measurements were made in the upright sitting position in the chair while the nose of the individuals was closed with a clip. Initial workload was applied at 60% of the maximal inspiratory pressure. Participants were asked to continue inspiring despite constant inspiratory workload. The respiratory muscle endurance value was obtained by multiplying the maximum workload of the test that can be sustained for at least one minute. Individuals were told that the test could be terminated if severe fatigue and extreme shortness of breath were experienced during the test. The results of the test were recorded.
Exercise Capacity
Time frame: This test was carried out at baseline.
The exercise capacity of the individuals was evaluated with the 6-Minute Walk Test (6 MWT), a submaximal test with high validity and reliability (ICC=0.94). 6MWT, made according to the American Thoracic Society guidlines.The distance covered in a 6-minute walk was calculated from the number of laps and meters. Values were recorded as a percentage of expected values for age and sex.
Exercise Capacity
Time frame: This test was carried out at the 24th hours after DOMS.
The exercise capacity of the individuals was evaluated with the 6-Minute Walk Test (6 MWT), a submaximal test with high validity and reliability (ICC=0.94). 6MWT, made according to the American Thoracic Society guidlines.The distance covered in a 6-minute walk was calculated from the number of laps and meters. Values were recorded as a percentage of expected values for age and sex.
Exercise Capacity
Time frame: This test was carried out at 48th hours after DOMS.
The exercise capacity of the individuals was evaluated with the 6-Minute Walk Test (6 MWT), a submaximal test with high validity and reliability (ICC=0.94). 6MWT, made according to the American Thoracic Society guidlines.The distance covered in a 6-minute walk was calculated from the number of laps and meters. Values were recorded as a percentage of expected values for age and sex.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
Background: PubMed 31110036Benditt JO. Respiratory Care of Patients With Neuromuscular Disease. Respir Care. 2019 Jun;64(6):679-688. doi: 10.4187/respcare.06827.
Background: PubMed 11809052Lieber RL, Friden J. Morphologic and mechanical basis of delayed-onset muscle soreness. J Am Acad Orthop Surg. 2002 Jan-Feb;10(1):67-73.
Background: PubMed 24596744Imtiyaz S, Veqar Z, Shareef MY. To Compare the Effect of Vibration Therapy and Massage in Prevention of Delayed Onset Muscle Soreness (DOMS). J Clin Diagn Res. 2014 Jan;8(1):133-6. doi: 10.7860/JCDR/2014/7294.3971. Epub 2014 Jan 12.
Background: PubMed 12617692Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
Background: PubMed 16007451Jamurtas AZ, Theocharis V, Tofas T, Tsiokanos A, Yfanti C, Paschalis V, Koutedakis Y, Nosaka K. Comparison between leg and arm eccentric exercises of the same relative intensity on indices of muscle damage. Eur J Appl Physiol. 2005 Oct;95(2-3):179-85. doi: 10.1007/s00421-005-1345-0. Epub 2005 Jul 9.
Background: PubMed 19015869Hotta N, Yamamoto K, Katayama K, Ishida K. The respiratory response to passive and active arm movements is enhanced in delayed onset muscle soreness. Eur J Appl Physiol. 2009 Feb;105(3):483-91. doi: 10.1007/s00421-008-0926-0. Epub 2008 Nov 15.
Background: PubMed 5772056Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sema Ozden principal investigator

Cyprus International University, School of Physical Education and Sports

Ozge Ozalp study director

Cyprus International University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Rabia Tugba Kilic study director

Ankara Yildirim Beyazit University,Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DOMS protocol in people with Muscle Soreness and Exercise, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Function Tests (FVC) (time frame: Pulmonary function test measurements were made in all individuals at baseline.). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05276986, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.