Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06229314 |
| Other study ID # |
2023/165 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
December 15, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Nuh Naci Yazgan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In adolescent idiopathic scoliosis (AIS), if the appropriate treatment approach is not
applied, the patient's 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.
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 (G*Power Version 3.1.9.4, Franz Faul, Universitat Kiel, Düsseldorf, Germany) a
power of 80% with 0.05 significance, a difference to be detected of 0.84 liter, and a
standard deviation of 0.59 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
(www.random.org, 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), FEV1/FVC, peak expiratory flow
rate (PEF), and forced expiratory volume from 25-75% (FEF25-75%), based on the European
Respiratory Society/American Thoracic Society (ERS/ATS) 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 patient's 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.
