Respiratory FunctionNCT04824573
Effects of Manual Therapy and Inspiratory Muscle Training
A study testing Inspiratory Muscle Training and Manual Therapy in people with Respiratory Function, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
The effectiveness of inspiratory muscle training (IMT) and manual therapy approaches added to the IMT program in healthy individuals with hyperkyphosis is uncertain. This study was aimed to determine the effects of manual therapy techniques added to IMT and IMT on pulmonary functions (FVC, FEV1, FEV1 / FVC, and PEF)… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function
- What is being tested?
- Inspiratory Muscle Training and Manual Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2019to 13 Mar 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
- individuals who were actively enrolled in Istanbul Esenyurt University
- those who agree to volunteer
- those between the ages of 18-24
- non-smokers
- those with hyperkyphosis
- those with a low physical activity level
Who cannot join
- those who have moderate or high levels of physical activity
- smokers
- those with a history of traumatic deformity in the thoracic spine
- those who have taken oral corticosteroids or antibiotics within one month
- those diagnosed with scoliosis of 20 ° and above
- those who have had cervical trauma, cervical spine surgery
Show all 9Show fewer
- those with respiratory system disorders (asthma, etc.)
- those with the meningeal tumor, vertebral tumor, spinal cord tumor, and similar tumors
- individuals with systemic ailments(heart disease, diabetes, hypertension, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Esenyurt University
Istanbul, Esenyurt, 34510
About this study
Official title: The Effect of Manual Therapy Approaches and Inspiratory Muscle Training on Respiratory Parameters in Healthy Individuals With Hyperkyphosis
The effectiveness of inspiratory muscle training (IMT) and manual therapy approaches added to the IMT program in healthy individuals with hyperkyphosis is uncertain. This study was aimed to determine the effects of manual therapy techniques added to IMT and IMT on pulmonary functions (FVC, FEV1, FEV1 / FVC, and PEF), forward head posture, and hyperkyphosis in healthy individuals with hyperkyphosis. Thirty-five individuals voluntarily participate to study were randomly divided into IMT and manual therapy groups. While all participants received twenty minutes of IMT twice a week for four weeks, manual therapy techniques were applied to the manual therapy group in addition to IMT. Pulmonary functions, forward head posture, and hyperkyphosis were evaluated before and after the treatments with spirometry device; cervical range of joint range of motion measuring device (CROM Deluxe), C0-wall (OWD), and C7-wall distance measurement respectively. Statistical Package for Social Sciences (SPSS 25.0) will be used to analyze the data in the research.
Read the detailed description
Hyperkyphosis, which is defined as a thoracic curvature higher than normal limits, is among the reasons that decrease chest wall mobility and lung function. In modern society, kyphosis in the thoracic vertebra increases with the increase in sitting time of people. It has been identified in studies that an increase in thoracic kyphosis and a decrease in the mobility of the thoracic region of the spine are associated with a decrease in respiratory functions such as Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1).
Manual therapy approaches consisting of different techniques (manipulation, joint mobilization and soft tissue mobilization) can be an effective approach to improve pulmonary function by increasing chest wall mobility. Manual therapy techniques applied to the thoracic region have been shown to cause a significant reduction in thoracic kyphosis. In a study, it has been shown that thoracic joint mobilization is effective in increasing FVC, FEV1 and Peak Expiratory Flow (PEF) in people with hyperkhyphosis and chronic neck pain. In addition, identified studies shows that manual therapy approaches applied to improve respiratory functions should include both the thoracic and cervical regions due to the relationship between cervical and thoracic spine movements.
Inspiratory Muscle Training (IMT) leads among the approaches used in the current literature to increase respiratory functions. There is important evidence that this technique which aims to increase the strength or endurance of the diaphragm and respiratory assist muscles activated during inspiration, improves respiratory function in the patient and healthy population. In the literature, there are studies examining the effects of IMT and manual therapy approaches on respiratory functions in individuals with chronic obstructive pulmonary disease (COPD), asthma and smokers. In a study conducted on smokers, the effects of manual therapy added to the IMT program on maximum inspiratory pressure (MIP) and other respiratory parameters were examined and a significant increase in MIP was observed, but a significant increase in other respiratory parameters not observed. In another study, it was stated that the addition of manual therapy and therapeutic exercise protocol to IMT in asthmatic individuals was more effective than IMT in improving forward head posture and kyphotic posture.
Although the studies on the effects of using IMT and manual therapy techniques together in healthy individuals on respiratory functions are very limited in the literature, more acute effects were investigated in these studies. In this context, the aim of our study is to evaluate the cervical and thoracic region manual therapy approaches added to IMT and IMT program in healthy individuals with hyperkyphosis; It is the determination of the effects on respiratory function values such as FVC, FEV1, tiffeneau index (FEV1 / FVC) and PEF, forward head posture and hyperkyphosis.
- Conditions
- Respiratory Function
- Being tested
- Inspiratory Muscle Training, Manual Therapy
- Keywords
- inspiration, kyphosis, manual therapy, posture, respiratory muscles
- Medical subject headings
- Respiratory Aspiration, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
Inspiratory Muscle Training (IMT) was performed with Powerbreathe Classic-Light Resistance device. To determine the intensity of the training, MIP values were measured with the help of the respiratory pressure meter-RP Check (MD Diagnostics Ltd. RP Check MIP \& MEP) device before each training. The pressure corresponding to 50 percent of the MIP value in the Powerbreathe device was determined as training workload. It was applied two days a week for four weeks, with five-set and five repetitions, for 20 minutes with 30 seconds rest in between. This inspiratory muscle training program has previously been used by several studies to improve respiratory muscle strength.
Manual TherapyOther
In the manual diaphragm release technique; While the participant was breathing in, the physiotherapist raised his hand slowly to accompany the rising movement of the ribs and deepened the contact during exhalation. The maneuver was performed in two sets of 10 deep breaths.
In thoracic mobilization application; The physiotherapist, standing behind the participant, wrapped the crossed arms from his right upper arm with his left hand and performed stretching, extension, lateral flexion, and thoracic rotation with his right hand.
In HVLA thoracic manipulation; the physiotherapist, with the support hand on the participant's elbows, applied HVLA thrust in the posterior-anterior and inferior-superior directions with the help of his body while the manipulating hand was on the transverse processes.
For cervical joint mobilization; the physiotherapist was applied using the right hand in flexion, extension, right-left rotation, and lateral flexion directions.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | The program of the IMT group (n=16) consists of individual sessions of approximately 20 minutes and the Powerbreathe device (IMT Technologies Ltd., Birmingham) was used for training. Receives: Device: Inspiratory Muscle Training |
| Manual Therapy | Experimental | In the manual therapy group (n=19), in addition to the approaches applied to the individuals in the IMT group, a total of eight sessions of manual therapy (manipulation, joint mobilization, and soft tissue mobilization) approaches, two days a week for four weeks and at least two days between sessions, were applied by an experienced physiotherapist in manual therapy. Manual therapy applications; included techniques targeting the cervical and thoracic regions. Techniques for the thoracic region; while it consists of manual diaphragm release, thoracic mobilization and High Velocity Low Amplitude (HVLA) thrust manipulation; the techniques applied to the cervical region consisted of soft tissue and joint mobilization. Receives: Device: Inspiratory Muscle Training; Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occiput Wall Distance (OWD)
Participants were asked to touch their occiput against the wall with their back and heels resting touch the wall and head facing forward.
The presence of hyperkyphosis was considered positive if the wall could not be touched with the occiput.
Measured: Change between baseline and 4 weeks
Forward Head Posture (cm)
The participants were sitting upright on the chair with their arms free at their sides and their feet touching the floor.
Participants were initially instructed to "sit in a comfortable, natural posture defined as the typical posture you take during your daily activities and do not move your head".
The head forward arm was attached to the CROM mainframe and the lower end of the control arm (vertebra locator) was held by the investigator on the C7 spinous process.
The vertebra locator was placed at a 90 ° angle with the forward arm of the CROM with the help of a bubble indicating that the instrument was straight.
The value on the head forward arm measures the distance in centimeters(cm) between the participant's bridge of nose and C7.
This measurement was repeated three times in total and the average values were recorded in centimeters(cm)
Measured: Change between baseline and 4 weeks
FEV1 (lt): Forced Expiratory Volume in 1 second
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FEV1 (lt) measurements.
Measured: Change between baseline and 4 weeks
C7-wall distance measurement (cm)
It is a valid and reliable method of testing performed by measuring the perpendicular distance from the C7 spinous process to the wall.
The measurement was repeated three times in a row with a short rest period and the mean values were recorded in centimeters (cm)
Measured: Change between baseline and 4 weeks
FVC(lt): Forced vital capacity
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
Measured: Change between baseline and 4 weeks
FEV1/FVC(%): Tiffenea index
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
Measured: Change between baseline and 4 weeks
PEF(lt/sn): Peak expiratory flow
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
Measured: Change between baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start3 Sep 2019
- Primary completion27 Sep 2019
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Respiratory FunctionStudies of the same condition, open and under way.
- 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
- The individuals are randomly allocated into Inspiratory Muscle Training (IMT) and Manual Therapy groups.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Arel University
- Responsible party
- Principal investigator, Şeyda YILDIZ, Bahçeşehir University
- Investigators
- Leyla ATAŞ BALCI, Assist Prof., Study director, Bahçeşehir UniversitySeçil ÖZKURT, Assist Prof., Study director, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824573
- Sponsor's protocol ID
- 1700897
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwangbo PN, Hwangbo G, Park J, Lee S. The Effect of Thoracic Joint Mobilization and Self-stretching Exercise on Pulmonary Functions of Patients with Chronic Neck Pain. J Phys Ther Sci. 2014 Nov;26(11):1783-6. doi: 10.1589/jpts.26.1783. Epub 2014 Nov 13.
PubMed 25435700Yaman O, Dalbayrak S. Kyphosis and review of the literature. Turk Neurosurg. 2014;24(4):455-65. doi: 10.5137/1019-5149.JTN.8940-13.0.
PubMed 25050667Lorbergs AL, O'Connor GT, Zhou Y, Travison TG, Kiel DP, Cupples LA, Rosen H, Samelson EJ. Severity of Kyphosis and Decline in Lung Function: The Framingham Study. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):689-694. doi: 10.1093/gerona/glw124.
PubMed 27341855Wall BA, Peiffer JJ, Losco B, Hebert JJ. The effect of manual therapy on pulmonary function in healthy adults. Sci Rep. 2016 Sep 12;6:33244. doi: 10.1038/srep33244.
PubMed 27616562Lopez-de-Uralde-Villanueva I, Candelas-Fernandez P, de-Diego-Cano B, Minguez-Calzada O, Del Corral T. The effectiveness of combining inspiratory muscle training with manual therapy and a therapeutic exercise program on maximum inspiratory pressure in adults with asthma: a randomized clinical trial. Clin Rehabil. 2018 Jun;32(6):752-765. doi: 10.1177/0269215517751587. Epub 2018 Jan 10.
PubMed 29318917Engel 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 17870419Jang SH, Bang HS. Effect of thoracic and cervical joint mobilization on pulmonary function in stroke patients. J Phys Ther Sci. 2016 Jan;28(1):257-60. doi: 10.1589/jpts.28.257. Epub 2016 Jan 30.
PubMed 26957769Yilmaz Yelvar GD, Cirak Y, Demir YP, Dalkilinc M, Bozkurt B. Immediate effect of manual therapy on respiratory functions and inspiratory muscle strength in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Jun 20;11:1353-7. doi: 10.2147/COPD.S107408. eCollection 2016.
PubMed 27382271Kim SY, Kim NS, Kim LJ. Effects of cervical sustained natural apophyseal glide on forward head posture and respiratory function. J Phys Ther Sci. 2015 Jun;27(6):1851-4. doi: 10.1589/jpts.27.1851. Epub 2015 Jun 30.
PubMed 26180334Shei RJ, Paris HL, Wilhite DP, Chapman RF, Mickleborough TD. The role of inspiratory muscle training in the management of asthma and exercise-induced bronchoconstriction. Phys Sportsmed. 2016 Nov;44(4):327-334. doi: 10.1080/00913847.2016.1176546. Epub 2016 Apr 26.
PubMed 27094568Bostanci O, Mayda H, Yilmaz C, Kabadayi M, Yilmaz AK, Ozdal M. Inspiratory muscle training improves pulmonary functions and respiratory muscle strength in healthy male smokers. Respir Physiol Neurobiol. 2019 Jun;264:28-32. doi: 10.1016/j.resp.2019.04.001. Epub 2019 Apr 3.
PubMed 30953791Lorenzo S, Nicotra CM, Mentreddy AR, Padia HJ, Stewart DO, Hussein MO, Quinn TA. Assessment of Pulmonary Function After Osteopathic Manipulative Treatment vs Standard Pulmonary Rehabilitation in a Healthy Population. J Am Osteopath Assoc. 2019 Feb 11. doi: 10.7556/jaoa.2019.026. Online ahead of print.
PubMed 30741314Goosey-Tolfrey V, Foden E, Perret C, Degens H. Effects of inspiratory muscle training on respiratory function and repetitive sprint performance in wheelchair basketball players. Br J Sports Med. 2010 Jul;44(9):665-8. doi: 10.1136/bjsm.2008.049486. Epub 2008 Jul 4.
PubMed 18603575Cahalin LP, Arena R. Novel methods of inspiratory muscle training via the Test of Incremental Respiratory Endurance (TIRE). Exerc Sport Sci Rev. 2015 Apr;43(2):84-92. doi: 10.1249/JES.0000000000000042.
PubMed 25607279Balbas-Alvarez L, Candelas-Fernandez P, Del Corral T, La Touche R, Lopez-de-Uralde-Villanueva I. Effect of Manual Therapy, Motor Control Exercise, and Inspiratory Muscle Training on Maximum Inspiratory Pressure and Postural Measures in Moderate Smokers: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2018 Jun;41(5):372-382. doi: 10.1016/j.jmpt.2017.11.004. Epub 2018 Jul 9.
PubMed 30001903
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Therapy Approaches and Inspiratory Muscle Training on Respiratory Parameters in Healthy Individuals With Hyperkyphosis
- ClinicalTrials.gov ID
- NCT04824573
- Acronym / sponsor ID
- 1700897
- Conditions
- Respiratory Function
- Keywords
- inspiration, kyphosis, manual therapy, posture, respiratory muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Istanbul Arel University
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 1 Apr 2021 (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 effectiveness of inspiratory muscle training (IMT) and manual therapy approaches added to the IMT program in healthy individuals with hyperkyphosis is uncertain. This study was aimed to determine the effects of manual therapy techniques added to IMT and IMT on pulmonary functions (FVC, FEV1, FEV1 / FVC, and PEF), forward head posture, and hyperkyphosis in healthy individuals with hyperkyphosis. Thirty-five individuals voluntarily participate to study were randomly divided into IMT and manual therapy groups. While all participants received twenty minutes of IMT twice a week for four weeks, manual therapy techniques were applied to the manual therapy group in addition to IMT. Pulmonary functions, forward head posture, and hyperkyphosis were evaluated before and after the treatments with spirometry device; cervical range of joint range of motion measuring device (CROM Deluxe), C0-wall (OWD), and C7-wall distance measurement respectively. Statistical Package for Social Sciences (SPSS 25.0) will be used to analyze the data in the research.
Detailed description
Hyperkyphosis, which is defined as a thoracic curvature higher than normal limits, is among the reasons that decrease chest wall mobility and lung function. In modern society, kyphosis in the thoracic vertebra increases with the increase in sitting time of people. It has been identified in studies that an increase in thoracic kyphosis and a decrease in the mobility of the thoracic region of the spine are associated with a decrease in respiratory functions such as Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1).
Manual therapy approaches consisting of different techniques (manipulation, joint mobilization and soft tissue mobilization) can be an effective approach to improve pulmonary function by increasing chest wall mobility. Manual therapy techniques applied to the thoracic region have been shown to cause a significant reduction in thoracic kyphosis. In a study, it has been shown that thoracic joint mobilization is effective in increasing FVC, FEV1 and Peak Expiratory Flow (PEF) in people with hyperkhyphosis and chronic neck pain. In addition, identified studies shows that manual therapy approaches applied to improve respiratory functions should include both the thoracic and cervical regions due to the relationship between cervical and thoracic spine movements.
Inspiratory Muscle Training (IMT) leads among the approaches used in the current literature to increase respiratory functions. There is important evidence that this technique which aims to increase the strength or endurance of the diaphragm and respiratory assist muscles activated during inspiration, improves respiratory function in the patient and healthy population. In the literature, there are studies examining the effects of IMT and manual therapy approaches on respiratory functions in individuals with chronic obstructive pulmonary disease (COPD), asthma and smokers. In a study conducted on smokers, the effects of manual therapy added to the IMT program on maximum inspiratory pressure (MIP) and other respiratory parameters were examined and a significant increase in MIP was observed, but a significant increase in other respiratory parameters not observed. In another study, it was stated that the addition of manual therapy and therapeutic exercise protocol to IMT in asthmatic individuals was more effective than IMT in improving forward head posture and kyphotic posture.
Although the studies on the effects of using IMT and manual therapy techniques together in healthy individuals on respiratory functions are very limited in the literature, more acute effects were investigated in these studies. In this context, the aim of our study is to evaluate the cervical and thoracic region manual therapy approaches added to IMT and IMT program in healthy individuals with hyperkyphosis; It is the determination of the effects on respiratory function values such as FVC, FEV1, tiffeneau index (FEV1 / FVC) and PEF, forward head posture and hyperkyphosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The individuals are randomly allocated into Inspiratory Muscle Training (IMT) and Manual Therapy groups.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Device: Inspiratory Muscle TrainingThe program of the IMT group (n=16) consists of individual sessions of approximately 20 minutes and the Powerbreathe device (IMT Technologies Ltd., Birmingham) was used for training. |
| Manual Therapy | Experimental | Device: Inspiratory Muscle Training, Other: Manual TherapyIn the manual therapy group (n=19), in addition to the approaches applied to the individuals in the IMT group, a total of eight sessions of manual therapy (manipulation, joint mobilization, and soft tissue mobilization) approaches, two days a week for four weeks and at least two days between sessions, were applied by an experienced physiotherapist in manual therapy. Manual therapy applications; included techniques targeting the cervical and thoracic regions. Techniques for the thoracic region; while it consists of manual diaphragm release, thoracic mobilization and High Velocity Low Amplitude (HVLA) thrust manipulation; the techniques applied to the cervical region consisted of soft tissue and joint mobilization. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- individuals who were actively enrolled in Istanbul Esenyurt University
- those who agree to volunteer
- those between the ages of 18-24
- non-smokers
- those with hyperkyphosis
Key exclusion criteria (9 listed)
- those who have moderate or high levels of physical activity
- smokers
- those with a history of traumatic deformity in the thoracic spine
- those who have taken oral corticosteroids or antibiotics within one month
- those diagnosed with scoliosis of 20 ° and above
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 |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory Muscle Training (IMT) was performed with Powerbreathe Classic-Light Resistance device. To determine the intensity of the training, MIP values were measured with the help of the respiratory pressure meter-RP Check (MD Diagnostics Ltd. RP Check MIP \& MEP) device before each training. The pressure corresponding to 50 percent of the MIP value in the Powerbreathe device was determined as training workload. It was applied two days a week for four weeks, with five-set and five repetitions, for 20 minutes with 30 seconds rest in between. This inspiratory muscle training program has previously been used by several studies to improve respiratory muscle strength. | Device | Inspiratory Muscle Training (IMT), Manual Therapy |
| Manual TherapyIn the manual diaphragm release technique; While the participant was breathing in, the physiotherapist raised his hand slowly to accompany the rising movement of the ribs and deepened the contact during exhalation. The maneuver was performed in two sets of 10 deep breaths. In thoracic mobilization application; The physiotherapist, standing behind the participant, wrapped the crossed arms from his right upper arm with his left hand and performed stretching, extension, lateral flexion, and thoracic rotation with his right hand. In HVLA thoracic manipulation; the physiotherapist, with the support hand on the participant's elbows, applied HVLA thrust in the posterior-anterior and inferior-superior directions with the help of his body while the manipulating hand was on the transverse processes. For cervical joint mobilization; the physiotherapist was applied using the right hand in flexion, extension, right-left rotation, and lateral flexion directions. | Other | Manual Therapy |
Primary outcome
Occiput Wall Distance (OWD)
Time frame: Change between baseline and 4 weeks
Participants were asked to touch their occiput against the wall with their back and heels resting touch the wall and head facing forward. The presence of hyperkyphosis was considered positive if the wall could not be touched with the occiput.
Forward Head Posture (cm)
Time frame: Change between baseline and 4 weeks
The participants were sitting upright on the chair with their arms free at their sides and their feet touching the floor. Participants were initially instructed to "sit in a comfortable, natural posture defined as the typical posture you take during your daily activities and do not move your head". The head forward arm was attached to the CROM mainframe and the lower end of the control arm (vertebra locator) was held by the investigator on the C7 spinous process. The vertebra locator was placed at a 90 ° angle with the forward arm of the CROM with the help of a bubble indicating that the instrument was straight. The value on the head forward arm measures the distance in centimeters(cm) between the participant's bridge of nose and C7. This measurement was repeated three times in total and the average values were recorded in centimeters(cm)
FEV1 (lt): Forced Expiratory Volume in 1 second
Time frame: Change between baseline and 4 weeks
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FEV1 (lt) measurements.
C7-wall distance measurement (cm)
Time frame: Change between baseline and 4 weeks
It is a valid and reliable method of testing performed by measuring the perpendicular distance from the C7 spinous process to the wall. The measurement was repeated three times in a row with a short rest period and the mean values were recorded in centimeters (cm)
FVC(lt): Forced vital capacity
Time frame: Change between baseline and 4 weeks
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
FEV1/FVC(%): Tiffenea index
Time frame: Change between baseline and 4 weeks
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
PEF(lt/sn): Peak expiratory flow
Time frame: Change between baseline and 4 weeks
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
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 1 Apr 2021.
- Background: PubMed 25435700Hwangbo PN, Hwangbo G, Park J, Lee S. The Effect of Thoracic Joint Mobilization and Self-stretching Exercise on Pulmonary Functions of Patients with Chronic Neck Pain. J Phys Ther Sci. 2014 Nov;26(11):1783-6. doi: 10.1589/jpts.26.1783. Epub 2014 Nov 13.
- Background: PubMed 25050667Yaman O, Dalbayrak S. Kyphosis and review of the literature. Turk Neurosurg. 2014;24(4):455-65. doi: 10.5137/1019-5149.JTN.8940-13.0.
- Background: PubMed 27341855Lorbergs AL, O'Connor GT, Zhou Y, Travison TG, Kiel DP, Cupples LA, Rosen H, Samelson EJ. Severity of Kyphosis and Decline in Lung Function: The Framingham Study. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):689-694. doi: 10.1093/gerona/glw124.
- Background: PubMed 27616562Wall BA, Peiffer JJ, Losco B, Hebert JJ. The effect of manual therapy on pulmonary function in healthy adults. Sci Rep. 2016 Sep 12;6:33244. doi: 10.1038/srep33244.
- Background: PubMed 29318917Lopez-de-Uralde-Villanueva I, Candelas-Fernandez P, de-Diego-Cano B, Minguez-Calzada O, Del Corral T. The effectiveness of combining inspiratory muscle training with manual therapy and a therapeutic exercise program on maximum inspiratory pressure in adults with asthma: a randomized clinical trial. Clin Rehabil. 2018 Jun;32(6):752-765. doi: 10.1177/0269215517751587. Epub 2018 Jan 10.
- 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.
- Background: PubMed 26957769Jang SH, Bang HS. Effect of thoracic and cervical joint mobilization on pulmonary function in stroke patients. J Phys Ther Sci. 2016 Jan;28(1):257-60. doi: 10.1589/jpts.28.257. Epub 2016 Jan 30.
- Background: PubMed 27382271Yilmaz Yelvar GD, Cirak Y, Demir YP, Dalkilinc M, Bozkurt B. Immediate effect of manual therapy on respiratory functions and inspiratory muscle strength in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Jun 20;11:1353-7. doi: 10.2147/COPD.S107408. eCollection 2016.
- Background: PubMed 26180334Kim SY, Kim NS, Kim LJ. Effects of cervical sustained natural apophyseal glide on forward head posture and respiratory function. J Phys Ther Sci. 2015 Jun;27(6):1851-4. doi: 10.1589/jpts.27.1851. Epub 2015 Jun 30.
- Background: PubMed 27094568Shei RJ, Paris HL, Wilhite DP, Chapman RF, Mickleborough TD. The role of inspiratory muscle training in the management of asthma and exercise-induced bronchoconstriction. Phys Sportsmed. 2016 Nov;44(4):327-334. doi: 10.1080/00913847.2016.1176546. Epub 2016 Apr 26.
- Background: PubMed 30953791Bostanci O, Mayda H, Yilmaz C, Kabadayi M, Yilmaz AK, Ozdal M. Inspiratory muscle training improves pulmonary functions and respiratory muscle strength in healthy male smokers. Respir Physiol Neurobiol. 2019 Jun;264:28-32. doi: 10.1016/j.resp.2019.04.001. Epub 2019 Apr 3.
- Background: PubMed 30741314Lorenzo S, Nicotra CM, Mentreddy AR, Padia HJ, Stewart DO, Hussein MO, Quinn TA. Assessment of Pulmonary Function After Osteopathic Manipulative Treatment vs Standard Pulmonary Rehabilitation in a Healthy Population. J Am Osteopath Assoc. 2019 Feb 11. doi: 10.7556/jaoa.2019.026. Online ahead of print.
- 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.
Leyla ATAŞ BALCI, Assist Prof. study director
Bahçeşehir University
Seçil ÖZKURT, Assist Prof. study director
Istanbul Arel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training and Manual Therapy in people with Respiratory Function, run by Bahçeşehir 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 6 inclusion and 9 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 1 Apr 2021. 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?
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?
Occiput Wall Distance (OWD) (time frame: Change between baseline and 4 weeks). The study lists 7 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 NCT04824573, which also lists 21 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 1 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.