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Effects of Manual Therapy and Inspiratory Muscle Training

Primary Purpose

Respiratory Function

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Manual Therapy
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Function focused on measuring inspiration, kyphosis, manual therapy, posture, respiratory muscles

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Istanbul Esenyurt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Inspiratory Muscle Training (IMT)

Manual Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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)
FEV1 (lt): Forced Expiratory Volume in 1 second
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FEV1 (lt) measurements.
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)
FVC(lt): Forced vital capacity
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
FEV1/FVC(%): Tiffenea index
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
PEF(lt/sn): Peak expiratory flow
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2021
Last Updated
March 28, 2021
Sponsor
Bahçeşehir University
Collaborators
Istanbul Arel University
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1. Study Identification

Unique Protocol Identification Number
NCT04824573
Brief Title
Effects of Manual Therapy and Inspiratory Muscle Training
Official Title
The Effect of Manual Therapy Approaches and Inspiratory Muscle Training on Respiratory Parameters in Healthy Individuals With Hyperkyphosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University
Collaborators
Istanbul Arel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Function
Keywords
inspiration, kyphosis, manual therapy, posture, respiratory muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The individuals are randomly allocated into Inspiratory Muscle Training (IMT) and Manual Therapy groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training (IMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occiput Wall Distance (OWD)
Description
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.
Time Frame
Change between baseline and 4 weeks
Title
Forward Head Posture (cm)
Description
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)
Time Frame
Change between baseline and 4 weeks
Title
FEV1 (lt): Forced Expiratory Volume in 1 second
Description
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FEV1 (lt) measurements.
Time Frame
Change between baseline and 4 weeks
Title
C7-wall distance measurement (cm)
Description
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)
Time Frame
Change between baseline and 4 weeks
Title
FVC(lt): Forced vital capacity
Description
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
Time Frame
Change between baseline and 4 weeks
Title
FEV1/FVC(%): Tiffenea index
Description
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
Time Frame
Change between baseline and 4 weeks
Title
PEF(lt/sn): Peak expiratory flow
Description
MicroQuark (COSMED, Albano Laziale, Italy) USB spirometer was used for the measurement of FVC (lt) measurements.
Time Frame
Change between baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leyla ATAŞ BALCI, Assist Prof.
Organizational Affiliation
Bahçeşehir University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seçil ÖZKURT, Assist Prof.
Organizational Affiliation
Istanbul Arel University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Esenyurt University
City
Istanbul
State/Province
Esenyurt
ZIP/Postal Code
34510
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Manual Therapy and Inspiratory Muscle Training

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