Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229314
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2024-01-10
Brief Title:
Effect of Inspiratory Muscle Training in Operated Adolescent Idiopathic Scoliosis
Sponsor:
Nuh Naci Yazgan University
Organization:
Nuh Naci Yazgan University
Study Overview
Official Title:
Effect of Inspiratory Muscle Training on Respiratory Function Exercise Capacity and Quality of Life in Operated Adolescent Idiopathic Scoliosis A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In adolescent idiopathic scoliosis AIS if the appropriate treatment approach is not applied the patients general health condition is negatively affected by the deterioration of pulmonary function Although studies in the literature evaluate individuals with AIS and investigate the effects of exercise training on their functional capacity no study has been found examining the effectiveness of post-surgical respiratory muscle strength training IMT Therefore this study was designed as a randomized controlled study with the aim of investigating the effectiveness of IMT in the early post-surgical period in individuals with AIS Participants included individuals diagnosed with AIS for whom a surgical decision was made by an orthopedic surgeon and who could cooperate in the tests to be conducted Twelve patients were in the IMT group and 12 were in the sham group Pulmonary function and respiratory and peripheral muscle strength were measured Functional capacities were assessed using the Six-Minute Walk Test 6MWT Disease-specific quality of life QoL was evaluated through the Scoliosis Research Society-22 SRS-22 and Oswestry Low Back Pain Questionnaire while dyspnea was assessed using the Modified Medical Research Council mMRC scale In the IMT group IMT was provided at 60 of the Maximum Inspiratory Pressure MIP while in the Sham group IMT was provided at 5 of MIP
Detailed Description:
There are very few studies in the literature that have investigated the effects of Inspiratory Muscle Training IMT to individuals with scoliosis In a study conducted by Kim et al in 2005 individuals with scoliosis and spinal cord injuries were given IMT and after treatment a decrease in Cobb angles a significant increase in lung volumes and respiratory muscle strengths were observed In a study by Basbug et al in 2023 the impact of IMT on pulmonary function and functional capacity in individuals with AIS was investigated There is no study in the literature on providing IMT after surgery in scoliosis patients It has been shown that surgical treatment alone in scoliosis patients is insufficient to improve respiratory capacity in the short term Therefore in this study we aimed to investigate the effects of postoperative IMT on pulmonary function functional capacity and quality of life in AIS patients
Methods Trial design
This study was planned as a single-blind randomized parallel group clinical trial Participants did not know which group they were in
Participants
Patients admitted to Kayseri System Hospital between February 2023 and December 2023 and diagnosed with idiopathic scoliosis were included in the study Data were collected at Nuh Naci Yazgan University Department of Physiotherapy and Rehabilitation Laboratories We calculated GPower Version 3194 Franz Faul Universitat Kiel Düsseldorf Germany a power of 80 with 005 significance a difference to be detected of 084 liter and a standard deviation of 059 liter in FVC value generating a sample of 10 individuals per group It was planned to take a total of 24 individuals 12 individuals in each group by calculating a minimum 20 drop-out rate A total of 24 individuals 12 in the IMT group and 12 in the sham group were included in the study
The study included voluntary individuals diagnosed with AIS who had been determined eligible for surgery by an orthopedic specialist were able to cooperate in the tests and did not have any orthopedic cardiac pulmonary vestibular or neurological diseases other than scoliosis Participants who had experienced acute infections within the last 15 days were excluded The data were collected from February 2023 to December 2023
Randomization
Twenty-four individuals were randomly selected using the computerized randomization method wwwrandomorg Dublin Ireland among 29 individuals who met the inclusion criteria and volunteered to participate in the study Then two numbers series of 12 randomly prepared numbers with numbers between 1 and 24 were created using the computerized randomization method Based on randomization the group consisting of the first number series was accepted as the exercise group and the other as the control group Afterward the numbers from 1 to 24 were written on paper and put in 24 sealed envelopes The patients in the study randomly chose an envelope when they came to their appointment and were included in the group where the number series with the chosen number coincided
Materials
First sociodemographic information of all individuals included in the study was obtained and all questionnaires were conducted Cobb angle was determined by the orthopedist using radiological imaging methods
Dyspnea was evaluated using the Modified Medical Research Council mMRC dyspnea scale It is a categorical scale in which individuals choose the most appropriate of the five expressions of dyspnea between 0-4 points to define their dyspnea levels
A spirometer Cosmed Pony FX Spirometer Milan Italy was used to measure forced vital capacity FVC forced expiratory volume in one second FEV1 FEV1FVC peak expiratory flow rate PEF and forced expiratory volume from 25-75 FEF25-75 based on the European Respiratory SocietyAmerican Thoracic Society ERSATS criteria The test was performed in the sitting position At least three technically acceptable measurements were obtained between the two best-measured FEV1 values with no more than a 5 difference and the best FEV1 value was selected for analysis
Respiratory muscle strength was measured Cosmed Pony FX Spirometer Milan Italy For the measurement of maximum inspiratory pressure MIP maximum expiration was performed on the person and the respiratory tract was immediately closed with a valve Then the person was asked to perform maximum inspiration for 1-3 sec For maximum expiratory pressure MEP a maximal inspiration was performed and then the person was asked to perform a maximal expiration of 2 sec against the closed airway At least three technically acceptable maneuvers were performed with no more than a 5 difference between the two best-measured values
Peripheral muscle strength was determined by measuring handgrip and quadriceps muscle strength using a digital dynamometer Jtech Commander Muscle Tester UT USA The mean values of the right and left side measurements were obtained Then the average of the measurements of the right and left sides were recorded in Newton N using each side
The functional capacity of individuals was evaluated using the Six-Minute Walk Test 6MWT Before and after the 6MWT heart rate blood pressure oxygen saturation SpO2 Cosmed Spiropalm 6MWT Rome Italy and respiratory frequency were assessed and fatigue levels during exertion and dyspnea were evaluated using the Modified Borg Scale
The disease-specific QoL for the cases was assessed using the Scoliosis Research Society-22 SRS-22 scale The Turkish version of the scale was used Additionally the Oswestry questionnaire was used to assess how much back pain affected daily activities
Intervention
In this study the primary outcome measurement was the pulmonary function test and the secondary outcome measurements were dyspnea respiratory and peripheral muscle strength functional capacity and QoL In the preoperative period dyspnea pulmonary function respiratory and peripheral muscle strength and QoL were evaluated respectively Finally functional capacity was measured with 6MWT Subsequently individuals underwent surgery Pulmonary function tests and respiratory muscle strength measurements were performed on the patients approximately two days after surgery post-op Inspiratory Muscle Training IMT was initiated at 60 of the MIP value IMT was administered using the Powerbreathe device Powerbreathe Plus Warwickshire England twice a day with 30x2 breaths The device was adjusted weekly based on the patients current MIP value and training continued at 60 of the MIP value The sham group received IMT at 5 of the measured MIP value with adjustments made weekly similar to the IMT group Patients were asked to keep a daily record of their sessions IMT was administered for a total of 6 weeks At the end of the sixth week post-op sixth week initial tests and questionnaires were repeated for individuals in both groups
Methods Trial design
This study was planned as a single-blind randomized parallel group clinical trial Participants did not know which group they were in
Participants
Patients admitted to Kayseri System Hospital between February 2023 and December 2023 and diagnosed with idiopathic scoliosis were included in the study Data were collected at Nuh Naci Yazgan University Department of Physiotherapy and Rehabilitation Laboratories We calculated GPower Version 3194 Franz Faul Universitat Kiel Düsseldorf Germany a power of 80 with 005 significance a difference to be detected of 084 liter and a standard deviation of 059 liter in FVC value generating a sample of 10 individuals per group It was planned to take a total of 24 individuals 12 individuals in each group by calculating a minimum 20 drop-out rate A total of 24 individuals 12 in the IMT group and 12 in the sham group were included in the study
The study included voluntary individuals diagnosed with AIS who had been determined eligible for surgery by an orthopedic specialist were able to cooperate in the tests and did not have any orthopedic cardiac pulmonary vestibular or neurological diseases other than scoliosis Participants who had experienced acute infections within the last 15 days were excluded The data were collected from February 2023 to December 2023
Randomization
Twenty-four individuals were randomly selected using the computerized randomization method wwwrandomorg Dublin Ireland among 29 individuals who met the inclusion criteria and volunteered to participate in the study Then two numbers series of 12 randomly prepared numbers with numbers between 1 and 24 were created using the computerized randomization method Based on randomization the group consisting of the first number series was accepted as the exercise group and the other as the control group Afterward the numbers from 1 to 24 were written on paper and put in 24 sealed envelopes The patients in the study randomly chose an envelope when they came to their appointment and were included in the group where the number series with the chosen number coincided
Materials
First sociodemographic information of all individuals included in the study was obtained and all questionnaires were conducted Cobb angle was determined by the orthopedist using radiological imaging methods
Dyspnea was evaluated using the Modified Medical Research Council mMRC dyspnea scale It is a categorical scale in which individuals choose the most appropriate of the five expressions of dyspnea between 0-4 points to define their dyspnea levels
A spirometer Cosmed Pony FX Spirometer Milan Italy was used to measure forced vital capacity FVC forced expiratory volume in one second FEV1 FEV1FVC peak expiratory flow rate PEF and forced expiratory volume from 25-75 FEF25-75 based on the European Respiratory SocietyAmerican Thoracic Society ERSATS criteria The test was performed in the sitting position At least three technically acceptable measurements were obtained between the two best-measured FEV1 values with no more than a 5 difference and the best FEV1 value was selected for analysis
Respiratory muscle strength was measured Cosmed Pony FX Spirometer Milan Italy For the measurement of maximum inspiratory pressure MIP maximum expiration was performed on the person and the respiratory tract was immediately closed with a valve Then the person was asked to perform maximum inspiration for 1-3 sec For maximum expiratory pressure MEP a maximal inspiration was performed and then the person was asked to perform a maximal expiration of 2 sec against the closed airway At least three technically acceptable maneuvers were performed with no more than a 5 difference between the two best-measured values
Peripheral muscle strength was determined by measuring handgrip and quadriceps muscle strength using a digital dynamometer Jtech Commander Muscle Tester UT USA The mean values of the right and left side measurements were obtained Then the average of the measurements of the right and left sides were recorded in Newton N using each side
The functional capacity of individuals was evaluated using the Six-Minute Walk Test 6MWT Before and after the 6MWT heart rate blood pressure oxygen saturation SpO2 Cosmed Spiropalm 6MWT Rome Italy and respiratory frequency were assessed and fatigue levels during exertion and dyspnea were evaluated using the Modified Borg Scale
The disease-specific QoL for the cases was assessed using the Scoliosis Research Society-22 SRS-22 scale The Turkish version of the scale was used Additionally the Oswestry questionnaire was used to assess how much back pain affected daily activities
Intervention
In this study the primary outcome measurement was the pulmonary function test and the secondary outcome measurements were dyspnea respiratory and peripheral muscle strength functional capacity and QoL In the preoperative period dyspnea pulmonary function respiratory and peripheral muscle strength and QoL were evaluated respectively Finally functional capacity was measured with 6MWT Subsequently individuals underwent surgery Pulmonary function tests and respiratory muscle strength measurements were performed on the patients approximately two days after surgery post-op Inspiratory Muscle Training IMT was initiated at 60 of the MIP value IMT was administered using the Powerbreathe device Powerbreathe Plus Warwickshire England twice a day with 30x2 breaths The device was adjusted weekly based on the patients current MIP value and training continued at 60 of the MIP value The sham group received IMT at 5 of the measured MIP value with adjustments made weekly similar to the IMT group Patients were asked to keep a daily record of their sessions IMT was administered for a total of 6 weeks At the end of the sixth week post-op sixth week initial tests and questionnaires were repeated for individuals in both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None