Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405451
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-08
First Post:
2024-04-08
Brief Title:
Respiratory Muscle Training Program in Patients With Multiple Sclerosis
Sponsor:
Universidad Europea de Madrid
Organization:
Universidad Europea de Madrid
Study Overview
Official Title:
Pilot Experimental Study on the Impact of a Respiratory Muscle Training Program in Patients With Multiple Sclerosis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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:
This is a quasi-experimental pre-post trial aimed at investigating the effects of respiratory muscle training RMT as trunk stabilization exercise in patients diagnosed with multiple sclerosis MS
Detailed Description:
Multiple sclerosis MS is a chronic disease of the central nervous system that can affect various bodily functions including the respiratory muscles Weakness in these muscles can lead to a range of complications including impacting trunk stability which may result in difficulties maintaining a balanced and stable posture
While the impact of MS on respiratory muscles and trunk stability is an area of interest in medical research a definitive consensus on the efficacy of respiratory muscle training RMT to improve trunk stability in MS patients has not yet been reached Several studies have yielded mixed results leading to uncertainty regarding the effectiveness of this specific intervention
The complex nature of multiple sclerosis necessitates a multidisciplinary approach to address its various clinical manifestations In addition to pharmacological treatment physical and occupational therapy play a crucial role in symptom management and improving patients quality of life Although respiratory muscle training may offer potential benefits further research and well-designed clinical trials are needed to determine its effectiveness and role in the comprehensive management of trunk stability in MS patients
- General objective The aim of this study is to investigate the effects of respiratory muscle training RMT as a trunk stabilization exercise in patients diagnosed with multiple sclerosis MS
- Specific objectives To analyze the effects of RMT on lung function measured through spirometric tests
To evaluate the effect of RMT on respiratory muscle strength using maximal inspiratory pressure MIP and maximal expiratory pressure MEP
To investigate the changes produced by RMT on abdominal and diaphragmatic muscle structures measured through ultrasound
To analyze the effect of RMT on trunk control measured with the Trunk Impairment Scale TIS
To study the effect of RMT on balance assessed with the Berg Balance Scale BBS
To investigate the effect of RMT on gait capacity and transfers evaluated through the Timed Up and Go TUG test
- Study design This is a quasi-experimental pre-post trial The research will be conducted following the principles outlined in the Helsinki Declaration and the Personal Data Protection and Guarantee of Digital Rights Act The conception of this project will follow the standard elements defined in the SPIRIT Standard Protocol Items Recommendations for Interventional Trials statement
- Sample size Sample size calculation will be based on data obtained from a pilot study involving 20 subjects Subsequently GPOWER software will be used to calculate the sample size using data obtained for the main variable expressed through diaphragm thickness to determine the effect size Throughout the project a power of 80 an alpha error of 005 one-tailed and a 95 confidence interval will be employed
- Subjects Subjects will be recruited through a previously signed agreement with the Multiple Sclerosis Patients Association the European University of Madrid and Sanitas Subjects will belong to the Multiple Sclerosis Patients Association and sessions will be conducted at Sanitas centers in Madrid affiliated with the agreement
- Inclusion criteria Age between 18 and 70 years Confirmed diagnosis of Multiple Sclerosis based on McDonalds criteria with a disease duration of more than two years relapsing or progressive
All multiple sclerosis patients according to the Expanded Disability Status Scale EDSS will be included
Stable medical treatment for at least six months prior to the intervention Absence of cognitive impairment with the ability to understand instructions and achieve a score equal to or greater than 24 on the Mini-Mental State Examination
All wheelchair-bound and non-wheelchair-bound patients will be included as both groups may benefit from the intervention due to increased trunk motor control However only subjects capable of walking will undergo walking-related variables or tests up to 6 on the EDSS scale
- Exclusion criteria Diagnosis of another neurological disease or musculoskeletal disorder other than MS
Diagnosis of any cardiovascular respiratory or metabolic disease or other conditions that may interfere with this study
Exacerbation or hospitalization in the last three months before initiating the assessment protocol or during the therapeutic intervention process
Receiving a cycle of steroids intravenously or orally six months before the start of the assessment protocol and within the intervention period of the study duration
- Variables measurements and measurement instruments Pulmonary function forced vital capacity FVC forced expiratory volume in one second FEV1 will be obtained
Muscle strength MIP and MEP variables maximum inspiratory pressure MIP and maximum expiratory pressure MEP will be measured
Ultrasound measurements of the diaphragm ultrasound measurement of diaphragm thickness ultrasound measurement of diaphragm excursion of the abdominal musculature ultrasound measurement of abdominal diastasis and abdominal wall
Trunk Impairment Scale TIS static and dynamic trunk stability will be measured
Berg Balance Scale BBS patient balance will be measured Timed Up and Go TUG activity limitations will be assessed Therapeutic adherence
- Therapetic intervention program Before starting the therapeutic intervention protocol patients will be informed about the study through an informed consent form APPENDIX I which they will sign and submit The necessary material for conducting the intervention will also be provided which will be delivered to the patients home
The therapeutic intervention program will be carried out for 30 minutes twice a day and six times a week following the protocol by Lee et al
Note During respiratory work patients may experience dizziness headaches changes in heart rate or desaturations Therefore to maintain safety margins participants will be continuously monitored with an FDA-approved fingertip pulse oximeter
To determine the percentage of work of MIP and MEP this variable will be taken using a Micro RPM respiratory pressure device from Micro Medical Kent United Kingdom Participants will work at 40-60 of the maximum MIP and MEP according to the clinical trial by Brita Klefbeck et al
Respiratory muscle training will be performed with the Threshold IMT-Philips inspiratory training device and the Threshold PEP expiratory training device both from Respironics Participants will be comfortably seated in a chair with their feet on the ground without back support and with the trunk at a 90 angle to the hips A conventional nasal clip will be used to prevent air leaks In forced expiratory training participants will use the ThresholdPEP with a custom mouthpiece and perform forced expiration through the resistance device Inspiratory muscle training will follow the same procedure using the Threshold IMT
Both inspiratory and expiratory training will be repeated 10-15 times 5 sets for 20 minutes in one session with a rest time of 30-60 seconds between each set
Patients will receive a phone call every Monday during the 6 weeks of the intervention to check if they are performing the exercises and to answer any questions arising from the training
- Statistical methods Qualitative variables will be expressed as absolute number and percentage and quantitative variables as mean standard deviation if they follow a normal distribution or as median and interquartile range IQR if not Kolmogorov-Smirnov or Shapiro-Wilk tests if the sample is less than 50 will be used to check the normality of data distributions
While the impact of MS on respiratory muscles and trunk stability is an area of interest in medical research a definitive consensus on the efficacy of respiratory muscle training RMT to improve trunk stability in MS patients has not yet been reached Several studies have yielded mixed results leading to uncertainty regarding the effectiveness of this specific intervention
The complex nature of multiple sclerosis necessitates a multidisciplinary approach to address its various clinical manifestations In addition to pharmacological treatment physical and occupational therapy play a crucial role in symptom management and improving patients quality of life Although respiratory muscle training may offer potential benefits further research and well-designed clinical trials are needed to determine its effectiveness and role in the comprehensive management of trunk stability in MS patients
- General objective The aim of this study is to investigate the effects of respiratory muscle training RMT as a trunk stabilization exercise in patients diagnosed with multiple sclerosis MS
- Specific objectives To analyze the effects of RMT on lung function measured through spirometric tests
To evaluate the effect of RMT on respiratory muscle strength using maximal inspiratory pressure MIP and maximal expiratory pressure MEP
To investigate the changes produced by RMT on abdominal and diaphragmatic muscle structures measured through ultrasound
To analyze the effect of RMT on trunk control measured with the Trunk Impairment Scale TIS
To study the effect of RMT on balance assessed with the Berg Balance Scale BBS
To investigate the effect of RMT on gait capacity and transfers evaluated through the Timed Up and Go TUG test
- Study design This is a quasi-experimental pre-post trial The research will be conducted following the principles outlined in the Helsinki Declaration and the Personal Data Protection and Guarantee of Digital Rights Act The conception of this project will follow the standard elements defined in the SPIRIT Standard Protocol Items Recommendations for Interventional Trials statement
- Sample size Sample size calculation will be based on data obtained from a pilot study involving 20 subjects Subsequently GPOWER software will be used to calculate the sample size using data obtained for the main variable expressed through diaphragm thickness to determine the effect size Throughout the project a power of 80 an alpha error of 005 one-tailed and a 95 confidence interval will be employed
- Subjects Subjects will be recruited through a previously signed agreement with the Multiple Sclerosis Patients Association the European University of Madrid and Sanitas Subjects will belong to the Multiple Sclerosis Patients Association and sessions will be conducted at Sanitas centers in Madrid affiliated with the agreement
- Inclusion criteria Age between 18 and 70 years Confirmed diagnosis of Multiple Sclerosis based on McDonalds criteria with a disease duration of more than two years relapsing or progressive
All multiple sclerosis patients according to the Expanded Disability Status Scale EDSS will be included
Stable medical treatment for at least six months prior to the intervention Absence of cognitive impairment with the ability to understand instructions and achieve a score equal to or greater than 24 on the Mini-Mental State Examination
All wheelchair-bound and non-wheelchair-bound patients will be included as both groups may benefit from the intervention due to increased trunk motor control However only subjects capable of walking will undergo walking-related variables or tests up to 6 on the EDSS scale
- Exclusion criteria Diagnosis of another neurological disease or musculoskeletal disorder other than MS
Diagnosis of any cardiovascular respiratory or metabolic disease or other conditions that may interfere with this study
Exacerbation or hospitalization in the last three months before initiating the assessment protocol or during the therapeutic intervention process
Receiving a cycle of steroids intravenously or orally six months before the start of the assessment protocol and within the intervention period of the study duration
- Variables measurements and measurement instruments Pulmonary function forced vital capacity FVC forced expiratory volume in one second FEV1 will be obtained
Muscle strength MIP and MEP variables maximum inspiratory pressure MIP and maximum expiratory pressure MEP will be measured
Ultrasound measurements of the diaphragm ultrasound measurement of diaphragm thickness ultrasound measurement of diaphragm excursion of the abdominal musculature ultrasound measurement of abdominal diastasis and abdominal wall
Trunk Impairment Scale TIS static and dynamic trunk stability will be measured
Berg Balance Scale BBS patient balance will be measured Timed Up and Go TUG activity limitations will be assessed Therapeutic adherence
- Therapetic intervention program Before starting the therapeutic intervention protocol patients will be informed about the study through an informed consent form APPENDIX I which they will sign and submit The necessary material for conducting the intervention will also be provided which will be delivered to the patients home
The therapeutic intervention program will be carried out for 30 minutes twice a day and six times a week following the protocol by Lee et al
Note During respiratory work patients may experience dizziness headaches changes in heart rate or desaturations Therefore to maintain safety margins participants will be continuously monitored with an FDA-approved fingertip pulse oximeter
To determine the percentage of work of MIP and MEP this variable will be taken using a Micro RPM respiratory pressure device from Micro Medical Kent United Kingdom Participants will work at 40-60 of the maximum MIP and MEP according to the clinical trial by Brita Klefbeck et al
Respiratory muscle training will be performed with the Threshold IMT-Philips inspiratory training device and the Threshold PEP expiratory training device both from Respironics Participants will be comfortably seated in a chair with their feet on the ground without back support and with the trunk at a 90 angle to the hips A conventional nasal clip will be used to prevent air leaks In forced expiratory training participants will use the ThresholdPEP with a custom mouthpiece and perform forced expiration through the resistance device Inspiratory muscle training will follow the same procedure using the Threshold IMT
Both inspiratory and expiratory training will be repeated 10-15 times 5 sets for 20 minutes in one session with a rest time of 30-60 seconds between each set
Patients will receive a phone call every Monday during the 6 weeks of the intervention to check if they are performing the exercises and to answer any questions arising from the training
- Statistical methods Qualitative variables will be expressed as absolute number and percentage and quantitative variables as mean standard deviation if they follow a normal distribution or as median and interquartile range IQR if not Kolmogorov-Smirnov or Shapiro-Wilk tests if the sample is less than 50 will be used to check the normality of data distributions
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