Effects of Manual Therapy and Inspiratory Muscle Training

March 28, 2021 updated by: Şeyda YILDIZ, Bahçeşehir University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Esenyurt
      • Istanbul, Esenyurt, Turkey, 34510
        • Istanbul Esenyurt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory Muscle Training (IMT)
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
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.
Experimental: Manual Therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change between baseline and 4 weeks
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)
Change between baseline and 4 weeks
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.
Change between baseline and 4 weeks
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)
Change between baseline and 4 weeks
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.
Change between baseline and 4 weeks
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.
Change between baseline and 4 weeks
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.
Change between baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Collaborators

Istanbul Arel University

Investigators

  • Study Director: Leyla ATAŞ BALCI, Assist Prof., Bahçeşehir University
  • Study Director: Seçil ÖZKURT, Assist Prof., Istanbul Arel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2019

Primary Completion (Actual)

September 27, 2019

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

March 6, 2021

First Submitted That Met QC Criteria

March 28, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 28, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1700897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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