WeightliftingNCT06606795
The Effects of Cervical and Thoracic Manipulation Therapy Applied to Weightlifting Athletes
A study testing Spinal Manipulation in people with Weightlifting and Breathing, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The effects of manipulation therapy on the autonomic nervous system have been examined in the literature and while no sympathetic or parasympathetic changes were found after upper thoracic manipulation, a decrease in sympathetic data was observed after lower thoracic manipulation and an increase in parasympathetic… Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Weightlifting, Breathing, Breath Tests
- What is being tested?
- Spinal Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2024to 1 Apr 2025
- 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 13 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being a weightlifter,
- Having asymptomatic dysfunction in the cervical and thoracic spine,
- Not having received any manipulative treatment in the last six months,
- Individuals who do not have a condition that prevents chiropractic manipulation treatment will be included in the study.
Who cannot join
- Having had an injury related to the musculoskeletal system in the upper and lower extremities in the last month,
- Having any neurological and psychiatric disorders,
- Having cervical disc herniations,
- Having a disorder related to the cardiac and respiratory systems,
- Having an infectious, rheumatological, metabolic and endocrinological disorder,
- Having dislocation, osteoporosis, ankylosing spondylitis, discopathy, rheumatoid arthritis,
- Taking anticoagulant treatment,
- Individuals who have recently undergone an operation involving the cervical and thoracic regions will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Konya, Selcuklu, 42130
Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr
About this study
The effects of manipulation therapy on the autonomic nervous system have been examined in the literature and while no sympathetic or parasympathetic changes were found after upper thoracic manipulation, a decrease in sympathetic data was observed after lower thoracic manipulation and an increase in parasympathetic data was observed. On the other hand, a different study found that thoracic manipulation did not cause any changes such as an increase or decrease in the autonomic nervous system. Therefore, although there are uncertainties in the autonomic role of manipulation therapy, its effect on respiration is intriguing when positive studies are considered.
In a study aiming to evaluate the effect of thoracic manipulation on respiratory function, segmental manipulation treatment was applied to healthy individuals by detecting the vertebrae in the thoracic region where normal joint movements were lost, and it was determined that the respiratory functions of the manipulation group improved significantly compared to the group that did not receive treatment. In another study conducted on healthy individuals, the subjects were divided into manipulation group, exercise and manipulation group and control groups. At the end of the study, it was determined that there was a significant increase in the respiratory functions of the participants in the manipulation group, while an additional increase was observed in the group combined with exercise, but this was not significant. No change was observed in the control group.
Read more
When the literature is examined, it is noteworthy that the effects of manipulation treatments on respiration remain unclear, and especially the inadequacy of studies on Olympic-style weightlifters and the ongoing search for increasing athletic performance in this area.
This study aims to examine the effects of cervical and thoracic manipulation treatments on respiratory muscle strength, respiratory functions and cervical and thoracic region joint range of motion in weightlifters.
The main question it aims to answer is:
- Is cervical and thoracic manipulation therapy applied to Olympic style weightlifters effective on respiration?
Read the detailed description
Our study is planned as a prospective, randomized controlled, single-blind experimental study. A total of 40 female and male elite and non-elite weightlifters between the ages of 13-35 will be evaluated for our study.
The minimum sample size of the study was found to be at least 40 people, with at least 20 people in each group, with 90% power at a 95% confidence interval.
- Conditions
- Weightlifting, Breathing, Breath Tests, Athlete, Spinal Manipulation
- Being tested
- Spinal Manipulation
- Keywords
- Weightlifting, Chiropractic, Breathing, Spinal Manipulation, Athlete
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationOther
Also called Chiropractic Manipulation
For the treatment to be applied in the SMT group, segmental dysfunctions will be determined using static and dynamic palpation techniques and the applications will be applied with a chiropractic method, high-speed, low-amplitude spinal manipulation method, at the level of the dysfunctional spine.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 20 people will be included in the control group. A total of two measurements will be taken, one at the beginning and one at the end of the study. Respiratory muscle strength, respiratory function, and cervical and thoracic joint range of motion will be evaluated in the measurements. The control group will continue their normal weightlifting training throughout the study. |
| Spinal Manipulation Group | Experimental | 20 people will be included in the Spinal Manipulation Therapy (SMT) group. This group will continue their normal weightlifting training during the study and in addition to the weightlifting training, they will receive a total of three sessions of cervical and thoracic manipulation therapy once a week for three weeks. A total of two measurements will be taken at the beginning and end of the study. Respiratory muscle strength, respiratory function and cervical and thoracic joint range of motion will be evaluated in the measurements. Receives: Other: Spinal Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
In our study, the respiratory muscle strength of the participants will be measured and recorded as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with the help of a portable device that can measure intraoral pressure electronically, which is a non-invasive method. The nose of the participant who makes maximal expiration in the sitting position will be closed with a valve and the MIP measurement will be completed by asking for maximal inspiration for 1-3 seconds and the measurements will be recorded. The nose of the participant who makes maximal inspiration in the sitting position will be closed with a valve and the MEP measurement will be completed by asking for maximal expiration for 1-3 seconds and the measurements will be recorded. The highest of the three best results among at least five measurements with no more than 10% difference between them will be recorded as the final data.
Measured: 3 weeks
Respiratory function test
Respiratory functions will be assessed with a portable spirometer with the patient in a sitting position according to the criteria determined by the American Thoracic Society and the European Respiratory Society. Spirometry measures multiple parameters during a single test. The test will be repeated three times. Participants will be asked to perform a single forced expiration followed by a single inspiration during normal breathing, and with this single measurement; forced expiratory volume in the first second of the respiratory function test (FEV₁), forced vital capacity (FVC), forced expiratory volume in the first second/forced vital capacity ratio (FEV₁/FVC), peak expiratory flow rate (PEF) and forced expiratory midflow rate (FEF%25-75) and the highest and percentages of the expected vital capacity (VC) values after three consecutive tests will be obtained. These results obtained with a single breathing test will be recorded as the highest and percentages of the expected values.
Measured: 3 weeks
Range of Motion of Cervical and Thoracic Regions
A gravity-dependent inclinometer and Spinal Mouse, which have been proven to be reliable in studies, will be used for measurements. Joint motion of the cervical and thoracic regions will be evaluated with the Lafayette brand Acumar Digital Dual Inclinometer and Spinal Mouse.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start4 Oct 2024 (estimated)
- Primary completion18 Oct 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for WeightliftingStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomly assigned to control and spinal manipulation groups.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kaan ALTUNOK, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606795
- Sponsor's protocol ID
- SelcukU_PT_WeightliftingMnp.1
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sillevis R, Cleland J, Hellman M, Beekhuizen K. Immediate effects of a thoracic spine thrust manipulation on the autonomic nervous system: a randomized clinical trial. J Man Manip Ther. 2010 Dec;18(4):181-90. doi: 10.1179/106698110X12804993427126.
PubMed 22131791Shin DC, Lee YW. The immediate effects of spinal thoracic manipulation on respiratory functions. J Phys Ther Sci. 2016 Sep;28(9):2547-2549. doi: 10.1589/jpts.28.2547. Epub 2016 Sep 29.
PubMed 27799691Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
PubMed 16264058Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
PubMed 10412550Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Engel RM, Vemulpad S. The effect of combining manual therapy with exercise on the respiratory function of normal individuals: a randomized control trial. J Manipulative Physiol Ther. 2007 Sep;30(7):509-13. doi: 10.1016/j.jmpt.2007.07.006.
PubMed 17870419
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cervical and Thoracic Manipulation Therapy Applied to Weightlifting Athletes
- ClinicalTrials.gov ID
- NCT06606795
- Acronym / sponsor ID
- SelcukU_PT_WeightliftingMnp.1
- Conditions
- Weightlifting, Breathing, Breath Tests, Athlete, Spinal Manipulation
- Keywords
- Weightlifting, Chiropractic, Breathing, Spinal Manipulation, Athlete
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 4 Oct 2024 (estimated)
- Primary completion
- 18 Oct 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 23 Sep 2024 (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.
The effects of manipulation therapy on the autonomic nervous system have been examined in the literature and while no sympathetic or parasympathetic changes were found after upper thoracic manipulation, a decrease in sympathetic data was observed after lower thoracic manipulation and an increase in parasympathetic data was observed. On the other hand, a different study found that thoracic manipulation did not cause any changes such as an increase or decrease in the autonomic nervous system. Therefore, although there are uncertainties in the autonomic role of manipulation therapy, its effect on respiration is intriguing when positive studies are considered.
In a study aiming to evaluate the effect of thoracic manipulation on respiratory function, segmental manipulation treatment was applied to healthy individuals by detecting the vertebrae in the thoracic region where normal joint movements were lost, and it was determined that the respiratory functions of the manipulation group improved significantly compared to the group that did not receive treatment. In another study conducted on healthy individuals, the subjects were divided into manipulation group, exercise and manipulation group and control groups. At the end of the study, it was determined that there was a significant increase in the respiratory functions of the participants in the manipulation group, while an additional increase was observed in the group combined with exercise, but this was not significant. No change was observed in the control group.
When the literature is examined, it is noteworthy that the effects of manipulation treatments on respiration remain unclear, and especially the inadequacy of studies on Olympic-style weightlifters and the ongoing search for increasing athletic performance in this area.
This study aims to examine the effects of cervical and thoracic manipulation treatments on respiratory muscle strength, respiratory functions and cervical and thoracic region joint range of motion in weightlifters.
The main question it aims to answer is:
- Is cervical and thoracic manipulation therapy applied to Olympic style weightlifters effective on respiration?
Detailed description
Our study is planned as a prospective, randomized controlled, single-blind experimental study. A total of 40 female and male elite and non-elite weightlifters between the ages of 13-35 will be evaluated for our study.
The minimum sample size of the study was found to be at least 40 people, with at least 20 people in each group, with 90% power at a 95% confidence interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to control and spinal manipulation groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –20 people will be included in the control group. A total of two measurements will be taken, one at the beginning and one at the end of the study. Respiratory muscle strength, respiratory function, and cervical and thoracic joint range of motion will be evaluated in the measurements. The control group will continue their normal weightlifting training throughout the study. |
| Spinal Manipulation Group | Experimental | Other: Spinal Manipulation20 people will be included in the Spinal Manipulation Therapy (SMT) group. This group will continue their normal weightlifting training during the study and in addition to the weightlifting training, they will receive a total of three sessions of cervical and thoracic manipulation therapy once a week for three weeks. A total of two measurements will be taken at the beginning and end of the study. Respiratory muscle strength, respiratory function and cervical and thoracic joint range of motion will be evaluated in the measurements. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being a weightlifter,
- Having asymptomatic dysfunction in the cervical and thoracic spine,
- Not having received any manipulative treatment in the last six months,
- Individuals who do not have a condition that prevents chiropractic manipulation treatment will be included in the study.
Key exclusion criteria (8 listed)
- Having had an injury related to the musculoskeletal system in the upper and lower extremities in the last month,
- Having any neurological and psychiatric disorders,
- Having cervical disc herniations,
- Having a disorder related to the cardiac and respiratory systems,
- Having an infectious, rheumatological, metabolic and endocrinological disorder,
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 |
|---|---|---|
| Spinal ManipulationAlso: Chiropractic ManipulationFor the treatment to be applied in the SMT group, segmental dysfunctions will be determined using static and dynamic palpation techniques and the applications will be applied with a chiropractic method, high-speed, low-amplitude spinal manipulation method, at the level of the dysfunctional spine. | Other | Spinal Manipulation Group |
Primary outcome
Respiratory muscle strength
Time frame: 3 weeks
In our study, the respiratory muscle strength of the participants will be measured and recorded as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with the help of a portable device that can measure intraoral pressure electronically, which is a non-invasive method. The nose of the participant who makes maximal expiration in the sitting position will be closed with a valve and the MIP measurement will be completed by asking for maximal inspiration for 1-3 seconds and the measurements will be recorded. The nose of the participant who makes maximal inspiration in the sitting position will be closed with a valve and the MEP measurement will be completed by asking for maximal expiration for 1-3 seconds and the measurements will be recorded. The highest of the three best results among at least five measurements with no more than 10% difference between them will be recorded as the final data.
Respiratory function test
Time frame: 3 weeks
Respiratory functions will be assessed with a portable spirometer with the patient in a sitting position according to the criteria determined by the American Thoracic Society and the European Respiratory Society. Spirometry measures multiple parameters during a single test. The test will be repeated three times. Participants will be asked to perform a single forced expiration followed by a single inspiration during normal breathing, and with this single measurement; forced expiratory volume in the first second of the respiratory function test (FEV₁), forced vital capacity (FVC), forced expiratory volume in the first second/forced vital capacity ratio (FEV₁/FVC), peak expiratory flow rate (PEF) and forced expiratory midflow rate (FEF%25-75) and the highest and percentages of the expected vital capacity (VC) values after three consecutive tests will be obtained. These results obtained with a single breathing test will be recorded as the highest and percentages of the expected values.
Range of Motion of Cervical and Thoracic Regions
Time frame: 3 weeks
A gravity-dependent inclinometer and Spinal Mouse, which have been proven to be reliable in studies, will be used for measurements. Joint motion of the cervical and thoracic regions will be evaluated with the Lafayette brand Acumar Digital Dual Inclinometer and Spinal Mouse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 22131791Sillevis R, Cleland J, Hellman M, Beekhuizen K. Immediate effects of a thoracic spine thrust manipulation on the autonomic nervous system: a randomized clinical trial. J Man Manip Ther. 2010 Dec;18(4):181-90. doi: 10.1179/106698110X12804993427126.
- Background: PubMed 27799691Shin DC, Lee YW. The immediate effects of spinal thoracic manipulation on respiratory functions. J Phys Ther Sci. 2016 Sep;28(9):2547-2549. doi: 10.1589/jpts.28.2547. Epub 2016 Sep 29.
- Background: PubMed 16264058Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
- Background: PubMed 10412550Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 17870419Engel RM, Vemulpad S. The effect of combining manual therapy with exercise on the respiratory function of normal individuals: a randomized control trial. J Manipulative Physiol Ther. 2007 Sep;30(7):509-13. doi: 10.1016/j.jmpt.2007.07.006.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manipulation in people with Weightlifting and Breathing, run by Selcuk University at 1 site 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (time frame: 3 weeks). The study lists 3 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 NCT06606795, which also lists 6 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 23 Sep 2024.