Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287983
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-24
Brief Title:
Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity
Sponsor:
Kayseri City Hospital
Organization:
Kayseri City Hospital
Study Overview
Official Title:
Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity in Patients With Ankylosing Spondylitis Receiving Anti-TNF Therapy Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
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 this study we aimed to evaluate the effect of Anti- tumor necrosis factor TNF treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF We also aimed to investigate the relationship between these parameters and disease activity spinal mobility and quality of life
Detailed Description:
Patients diagnosed with AS who applied to outpatient clinic received anti- tumor necrosis factor TNF treatment for at least 6 months and have been evaluated will be included in the study
Patients who agree to participate in the study will be asked to sign a consent form At the beginning all patients name-surname age height body weight body mass index smoking-alcohol use profession marital status education duration of ankylosing spondylitis disease history of corticosteroid use presence of systemic and extra-articular involvement medications used and additional diseases will be questioned and recorded in their files
It was planned to include 30 male and 14 female patients in the study by calculating the femalemale ratio of patients diagnosed with As who applied to hospital in the last year and in line with the literature A total of 44 patients will be randomly randomized into 2 groups using the sealed envelope randomization method The exercise program will be applied to both groups 3 sessions a week for 60 minutes for 6 weeks
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 310 sets
Inspiratory muscle training will also be added to the intervention group
Inspiratory muscle training will be started at an intensity of 50 of the patients measured PIMAX value and will be increased by 2 cmH20 per day according to patient tolerance and will be applied for a total of 6 weeks 5 days per week 3 sessions per day 10 breaths per session
Patients included in the study were evaluated with BASDAI Bath Ankylosing Spondylitis Disease Activity Index BASFIBath Ankylosing Spondylitis Functional Index ASQoLThe Ankylosing Spondylitis Quality of Life Modified Borg Scale measurement of dyspnea at maximum exercise with Visual Analog Scale VAS 6-minute walk test chest expansion measurement and respiratory function test spirometry at 0 6 12 and 24 weeks will be evaluated
Patients who agree to participate in the study will be asked to sign a consent form At the beginning all patients name-surname age height body weight body mass index smoking-alcohol use profession marital status education duration of ankylosing spondylitis disease history of corticosteroid use presence of systemic and extra-articular involvement medications used and additional diseases will be questioned and recorded in their files
It was planned to include 30 male and 14 female patients in the study by calculating the femalemale ratio of patients diagnosed with As who applied to hospital in the last year and in line with the literature A total of 44 patients will be randomly randomized into 2 groups using the sealed envelope randomization method The exercise program will be applied to both groups 3 sessions a week for 60 minutes for 6 weeks
The Sample Spondylitis Exercise Program recommended by the Spondylitis Association of America will be translated into Turkish and each exercise will be applied in 310 sets
Inspiratory muscle training will also be added to the intervention group
Inspiratory muscle training will be started at an intensity of 50 of the patients measured PIMAX value and will be increased by 2 cmH20 per day according to patient tolerance and will be applied for a total of 6 weeks 5 days per week 3 sessions per day 10 breaths per session
Patients included in the study were evaluated with BASDAI Bath Ankylosing Spondylitis Disease Activity Index BASFIBath Ankylosing Spondylitis Functional Index ASQoLThe Ankylosing Spondylitis Quality of Life Modified Borg Scale measurement of dyspnea at maximum exercise with Visual Analog Scale VAS 6-minute walk test chest expansion measurement and respiratory function test spirometry at 0 6 12 and 24 weeks will be evaluated
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