Clinical trial NCT04824573: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Function
Keywords: inspiration
kyphosis
manual therapy
posture
respiratory muscles
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
Collaborators: name: Istanbul Arel University
First posted: 2021-04-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The individuals are randomly allocated into Inspiratory Muscle Training (IMT) and Manual Therapy groups.
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Occiput Wall Distance (OWD)
timeFrame: Change between baseline and 4 weeks
measure: Forward Head Posture (cm)
timeFrame: Change between baseline and 4 weeks
measure: FEV1 (lt): Forced Expiratory Volume in 1 second
timeFrame: Change between baseline and 4 weeks
measure: C7-wall distance measurement (cm)
timeFrame: Change between baseline and 4 weeks
measure: FVC(lt): Forced vital capacity
timeFrame: Change between baseline and 4 weeks
measure: FEV1/FVC(%): Tiffenea index
timeFrame: Change between baseline and 4 weeks
measure: PEF(lt/sn): Peak expiratory flow
timeFrame: Change between baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Esenyurt University
state: Esenyurt
Study officials:
affiliation: Bahçeşehir University
name: Leyla ATAŞ BALCI, Assist Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul Arel University
name: Seçil ÖZKURT, Assist Prof.
role: STUDY_DIRECTOR
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