NCT05276986

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

November 17, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

March 14, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 12, 2022

Last Update Submit

March 2, 2022

Conditions

Keywords

Muscle SorenessExerciseRespiratory MusclesRespiratory Function Tests

Outcome Measures

Primary Outcomes (21)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    This test was carried out at 48th hours after DOMS.

Study Arms (1)

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.

Other: DOMS protocol

Interventions

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.

DOMS protocol group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Lung disease
  • Cardiovascular disease
  • Neurological disease
  • Orthopedic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Ankara, Turkey (Türkiye)

Location

Faculty of Health Sciences, Departmant of Physiotherapy and Rehabilitation, Baskent University

Ankara, Turkey (Türkiye)

Location

Related Publications (7)

  • Benditt JO. Respiratory Care of Patients With Neuromuscular Disease. Respir Care. 2019 Jun;64(6):679-688. doi: 10.4187/respcare.06827.

    PMID: 31110036BACKGROUND
  • 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.

    PMID: 11809052BACKGROUND
  • 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.

    PMID: 24596744BACKGROUND
  • 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.

    PMID: 12617692BACKGROUND
  • 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.

    PMID: 16007451BACKGROUND
  • 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.

    PMID: 19015869BACKGROUND
  • 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.

    PMID: 5772056BACKGROUND

MeSH Terms

Conditions

MyalgiaMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Sema Ozden

    Cyprus International University, School of Physical Education and Sports

    PRINCIPAL INVESTIGATOR
  • Ozge Ozalp

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

    STUDY DIRECTOR
  • Rabia Tugba Kilic

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

    STUDY DIRECTOR
  • Hayri Baran Yosmaoglu

    Baskent University, Physiotherapy and Rehabilitation Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 24 healthy university students (n=11 female, n=13 male) with a mean age of 21±2 years included the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

March 14, 2022

Study Start

November 17, 2019

Primary Completion

January 12, 2020

Study Completion

January 12, 2020

Last Updated

March 14, 2022

Record last verified: 2022-01

Locations