Effects of Manual Therapy and Inspiratory Muscle Training

Respiratory Function Clinical Trial

Official title:

The Effect of Manual Therapy Approaches and Inspiratory Muscle Training on Respiratory Parameters in Healthy Individuals With Hyperkyphosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824573
• Other study ID #: 1700897
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: March 2021
• Source: Bahçesehir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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), 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 13, 2020
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.)

Related Conditions & MeSH terms

• Respiratory Aspiration
• Respiratory Function

Intervention

Device:
• Inspiratory Muscle Training
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.

Other:
• Manual Therapy
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.

Locations

Country	Name	City	State
Turkey	Istanbul Esenyurt University	Istanbul	Esenyurt

Sponsors (2)

Lead Sponsor	Collaborator
Bahçesehir University	Istanbul Arel University

Country where clinical trial is conducted

Turkey, 

References & Publications (21)

Amatachaya P, Wongsa S, Sooknuan T, Thaweewannakij T, Laophosri M, Manimanakorn N, Amatachaya S. Validity and reliability of a thoracic kyphotic assessment tool measuring distance of the seventh cervical vertebra from the wall. Hong Kong Physiother J. 2016 Jul 13;35:30-36. doi: 10.1016/j.hkpj.2016.05.001. eCollection 2016 Dec. — View Citation

Balbás-Álvarez L, Candelas-Fernández P, Del Corral T, La Touche R, López-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. — View Citation

Bostanci Ö, Mayda H, Yilmaz C, Kabadayi M, Yilmaz AK, Özdal 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. — View Citation

Cahalin 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. Review. — View Citation

Engel 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. — View Citation

Garrett TR, Youdas JW, Madson TJ. Reliability of measuring forward head posture in a clinical setting. J Orthop Sports Phys Ther. 1993 Mar;17(3):155-60. — View Citation

Goosey-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. — View Citation

Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. — View Citation

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. — View Citation

Jang 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. — View Citation

Kim 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. — View Citation

López-de-Uralde-Villanueva I, Candelas-Fernández P, de-Diego-Cano B, Mínguez-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. — View Citation

Lorbergs 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. — View Citation

Lorenzo 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. [Epub ahead of print] — View Citation

Romer LM, McConnell AK, Jones DA. Effects of inspiratory muscle training on time-trial performance in trained cyclists. J Sports Sci. 2002 Jul;20(7):547-62. — View Citation

Shei 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. Epub 2016 Apr 26. Review. — View Citation

Sonetti DA, Wetter TJ, Pegelow DF, Dempsey JA. Effects of respiratory muscle training versus placebo on endurance exercise performance. Respir Physiol. 2001 Sep;127(2-3):185-99. — View Citation

Volianitis S, McConnell AK, Koutedakis Y, McNaughton L, Backx K, Jones DA. Inspiratory muscle training improves rowing performance. Med Sci Sports Exerc. 2001 May;33(5):803-9. — View Citation

Wall 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. — View Citation

Yaman 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. Review. — View Citation

Yilmaz Yelvar GD, Çirak Y, Demir YP, Dalkilinç 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change between baseline and 4 weeks
Primary	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)	Change between baseline and 4 weeks
Primary	FEV1 (lt): Forced Expiratory Volume in 1 second	MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FEV1 (lt) measurements.	Change between baseline and 4 weeks
Primary	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)	Change between baseline and 4 weeks
Primary	FVC(lt): Forced vital capacity	MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.	Change between baseline and 4 weeks
Primary	FEV1/FVC(%): Tiffenea index	MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.	Change between baseline and 4 weeks
Primary	PEF(lt/sn): Peak expiratory flow	MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.	Change between baseline and 4 weeks