Effects of Manual Therapy and Inspiratory Muscle Training

NCT04824573 | Completed DMC

• 1 other identifier: 1700897
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Function

Keywords

inspiration; kyphosis; manual therapy; posture; respiratory muscles

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Device: Inspiratory Muscle Training; Other: Manual Therapy

Interventions

Inspiratory Muscle Training DEVICE

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.

Inspiratory Muscle Training (IMT); Manual Therapy

Manual Therapy OTHER

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.

Manual Therapy

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Bahçeşehir University: lead
• Istanbul Arel University: collaborator

Study Sites (1)

Istanbul Esenyurt University

Istanbul, Esenyurt, 34510, Turkey (Türkiye)

Location

Related Publications (21)

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• 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.

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• Lopez-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.

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• 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. doi: 10.1016/j.jmpt.2007.07.006.

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• 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.

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• Yilmaz 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.

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  PMID: 27094568 BACKGROUND

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  PMID: 30953791 BACKGROUND

• 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. Online ahead of print.

  PMID: 30741314 BACKGROUND

• 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.

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• 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.

  PMID: 25607279 BACKGROUND

• Balbas-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.

  PMID: 30001903 BACKGROUND

• 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.

  PMID: 30931031 BACKGROUND

• 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. doi: 10.2519/jospt.1993.17.3.155.

  PMID: 8472080 BACKGROUND

• 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.

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• 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. doi: 10.1016/s0034-5687(01)00250-x.

  PMID: 11504589 BACKGROUND

• 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. doi: 10.1097/00005768-200105000-00020.

  PMID: 11323552 BACKGROUND

• 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. doi: 10.1080/026404102760000053.

  PMID: 12166881 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration; Kyphosis

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Leyla ATAŞ BALCI, Assist Prof.

  Bahçeşehir University

  STUDY DIRECTOR

• Seçil ÖZKURT, Assist Prof.

  Istanbul Arel University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Physiotherapist

Model Details: The individuals are randomly allocated into Inspiratory Muscle Training (IMT) and Manual Therapy groups.

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: April 1, 2021
• Study Start: September 3, 2019
• Primary Completion: September 27, 2019
• Study Completion: March 13, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)