Inspiratory Muscle Training in Amiotrophyc Lateral Sclerosis
ConditionAmyotrophic Lateral Slerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Ramon Llull
About this trial
Amyotrophic Lateral Sclerosis (ALS) progressively damages the nerve cells responsible for voluntary muscle movement. Over time, this leads to weakness in different muscles such as those used for movement or breathing. Breathing problems are one of the main causes of complications and reduced survival in people with ALS. This happens because the inspiratory muscles-those that help draw air into the lungs-gradually lose strength.
The study has the aim to explore the benefits of training inspiratory muscles in ALS patients in order to maintain the setrength of these muscles for as long as possible and look the impact on respiratory function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with spinal ALS
men and women
diagnosis date less than two years ago, according to the "El Escorial" criteria (Appendix 2)
PIM above the lower limit of normal
Disqualifiers
Patients with signs of respiratory muscle weakness (MIP and MEP below the LLN and abnormal decubitus tests19-21)
Nocturnal hypoventilation
Inability to perform the measurement tests
Inability to understand and perform the exercises
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratory muscle training
DeviceTraining will consist of resisted breathing exercises at 30% of MIP, twice daily for 12 weeks. MIP will be reassessed at 1 and 2 months to adjust the load. After 12 weeks, participants will continue the same exercises twice per week for 12 months at 40% of final MIP. All participants will also receive standard respiratory physiotherapy according to disease stage. Follow-up assessments will occur at 1, 2, 3, 6, and 12 months.
Sham training
DeviceFollow a routine respiratory physiotherapy treatment (which will be recorded in the study) and an inspiratory muscle training protocol with a sham device; that is, it will not have the valve that imposes resistance.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Inspiratory muscle preassure: MIP
We follow the ATS/ERS recommended protocol. From a sitting position, the patient performs a full expiration to reach residual volume. Using a mouthpiece connected to a manometer, the patient is then instructed to perform a maximal inspiration and hold it for at least 3 seconds. This measurement will be repeated at least three times to ensure a minimal difference of ≤5% between attempts.
Time frame
Baseline: Initial evaluation before the intervention. During intervention: Assessments at months 1, 2, and 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.Secondary outcomes
1
Maximal Expiratory Pressure: MEP
We follow the ATS/ERS recommended protocol. From a sitting position, the patient performs a full inspiration to reach total lung capacity. Using a mouthpiece connected to a manometer, the patient is then instructed to perform a maximal expiration and hold it for at least 3 seconds. This measurement will be repeated at least three times to ensure a minimal difference of ≤5% between attempts.
Time frame
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effect2
Quality of life: ALSAQ-40
The Spanish version of the ALSAQ-40 scale will be used. Each study participant will complete the questionnaire in a quiet environment, with the questions presented clearly to ensure they can be answered confidently and without hesitation.
Time frame
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.3
Forced espirometry
We follow the ATS/ERS recommended protocol in siiting and supine position. Patient will be encourage to do a maximal and forced expiration followed by a deep inspiration. This measurement will be reapited at least 3 times to ensure a minimal difference of 5% inbetween. Expiratory flow and volumen variables will be taked.
Time frame
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.4
Functional assessment: ALSFRS-R
ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) is a questionnaire used to assess the physical function of patients with Amyotrophic Lateral Sclerosis (ALS), measuring 12 aspects such as swallowing, speaking, walking or breathing. Each aspect is scored from 0 (no ability) to 4 (normal), adding up to a total of 48 points, which allows monitoring the progression of the disease.
Time frame
Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.Sponsors and contacts
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Source ClinicalTrials.gov