Combined Respiratory Training for ALS
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Southeastern University
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed:
1. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS.
2. Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment.
3. Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot use prescription cough assist or non-invasive volume ventilation devices.
Is Combined Respiratory Training a promising treatment for ALS?Yes, Combined Respiratory Training, which includes techniques like Lung Volume Recruitment and Expiratory Muscle Strength Training, shows promise for improving coughing and lung function in people with ALS.168910
What data supports the idea that Combined Respiratory Training for ALS is an effective treatment?The available research shows that Combined Respiratory Training, which includes techniques like lung volume recruitment and expiratory muscle strength training, can be effective for ALS patients. One study found that lung volume recruitment improved coughing and lung function shortly after treatment. Another case study showed that a person with ALS who did respiratory training at home for two years had significant improvements in their ability to breathe in and out forcefully and cough effectively. These findings suggest that this treatment can help maintain or improve respiratory function in ALS patients.123510
What safety data exists for Combined Respiratory Training in ALS?The safety data for Combined Respiratory Training in ALS, which includes techniques like Lung Volume Recruitment (LVR) and Expiratory Muscle Strength Training (EMST), is supported by several studies. These studies have generally focused on the effects of these techniques on respiratory function, coughing, and pulmonary function in ALS patients. For instance, a study on LVR showed positive effects on forced vital capacity and peak cough flow without significant adverse effects. Another study on EMST evaluated its impact on pulmonary, swallow, and cough function, indicating its potential benefits. Overall, these studies suggest that these respiratory training techniques are effective and safe for improving respiratory function in ALS patients, although more research is needed to fully understand their safety profile.147910
Eligibility Criteria
This trial is for people with ALS who have had symptoms for less than 2 years, can't already use respiratory training devices, and don't have a tracheostomy or need invasive breathing support. They shouldn't be in other studies that affect coughing or breathing and must not have severe lung diseases like COPD.Inclusion Criteria
I have never undergone lung volume or expiratory muscle strength training.
My cough strength is weaker than normal for my age and gender.
Exclusion Criteria
I have a tracheostomy or use a ventilator to help me breathe.
I do not have severe lung problems or a history of collapsed lung.
I use a machine to help with my cough or breathing.
I have been diagnosed with frontotemporal dementia or severe memory problems.
Participant Groups
The study tests if combining two types of breathing exercises (LVR+EMST) helps improve cough strength, breath control, swallowing difficulties, and overall quality of life in up to 39 patients with ALS. It also looks at the impact on caregiver burden.
1Treatment groups
Experimental Treatment
Group I: Lung Volume Recruitment +Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention
All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen following a 5-week no-intervention lead-in period.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Nova Southeastern UniversityFort Lauderdale, FL
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Who is running the clinical trial?
Nova Southeastern UniversityLead Sponsor
Congressionally Directed Medical Research ProgramsCollaborator
References
The effects of lung volume recruitment on coughing and pulmonary function in patients with ALS. [2015]Our objective was to study the intensity and duration of the effects of lung volume recruitment, a manual breath stacking technique, on pulmonary function and coughing in individuals with amyotrophic lateral sclerosis (ALS). Twenty-nine individuals with ALS participated in this study. A cross-over research design was used to compare effects of lung volume recruitment to a control condition. Treatment outcome measures included forced vital capacity (FVC), sniff nasal pressure (SnP) and peak cough flow (PCF). Results demonstrated that LVR had a significantly positive effect on FVC for up to 15 min following treatment but did not have a facilitative effect on SnP at any time-point. LVR had a significantly positive effect on PCF during unassisted coughing at both 15 min and 30 min following treatment, and there was no significant decrease in flow rates from baseline to 30 min later. In conclusion, lung volume recruitment may be an effective treatment for improving coughing and pulmonary function in individuals with ALS. Future research should be focused on determining patient characteristics that contribute to response to treatment, as well as randomized controlled trials of the technique.
A preliminary randomized trial of the mechanical insufflator-exsufflator versus breath-stacking technique in patients with amyotrophic lateral sclerosis. [2017]A major problem faced by patients with amyotrophic lateral sclerosis (ALS) in respiratory failure is the inability to cough effectively. Forty eligible ALS patients were randomized to the breath-stacking technique using a lung volume recruitment bag (n = 21) or mechanical insufflator-exsufflator MI-E (n = 19) and followed up at three-monthly intervals for at least 12 months or until death. Results showed that there were 13 episodes of chest infection in the breath-stacking group and 19 episodes in the MI-E group (p = 0.92), requiring 90 and 95 days of antibiotics, respectively (p = 0.34). The mean duration of symptoms per chest infection was 6.9 days in the breath-stacking group and 3.9 days in MI-E group (p = 0.16). There were six episodes of hospitalization in each group (p = 0.64). The chance of hospitalization, in the event of a chest infection, was 0.46 in the breath-stacking group and 0.31 in MI-E group (p = 0.47). Median survival in the breath-stacking group was 535 days and 266 days in the MI-E group (p = 0.34). The QoL was maintained above 75% of baseline for a median of 329 days in the breath-stacking group and 205 days in the MI-E group (p = 0.41). In conclusion, lack of statistically significant differences due to sub-optimal power and confounders precludes a definitive conclusion with respect to the relative efficacy of one cough augmentation technique over the other. This study however, provides useful lessons and informative data, needed to strengthen the power calculation, inclusion criteria and randomization factors for a large scale definitive trial. Until such a definitive trial can be undertaken, we recommend the breath-stacking technique as a low-cost, first-line intervention for volume recruitment and cough augmentation in patients with ALS who meet the criteria for intervention with non-invasive ventilation.
Impact of expiratory strength training in amyotrophic lateral sclerosis. [2018]We evaluated the feasibility and impact of expiratory muscle strength training (EMST) on respiratory and bulbar function in persons with amyotrophic lateral sclerosis (ALS).
Impact of expiratory strength training in amyotrophic lateral sclerosis: Results of a randomized, sham-controlled trial. [2020]The purpose of this study was to determine the impact of an in-home expiratory muscle strength training (EMST) program on pulmonary, swallow, and cough function in individuals with amyotrophic lateral sclerosis (ALS).
Combined respiratory training in an individual with C9orf72 amyotrophic lateral sclerosis. [2019]This case study examined the impact of a respiratory strength training program targeting inspiratory and expiratory musculature in an individual with C9orf72 amyotrophic lateral sclerosis (ALS). The individual tolerated 24 months of respiratory training completed at home, 50 repetitions per day, and 5 days per week. Significant increases in maximum inspiratory pressure (from 71 to 134 centimeters of water), maximum expiratory pressure (from 108 to 197 centimeters of water) and peak cough flow (from 331 to 655 Liters per minute) were noted and forced vital capacity remained unchanged. A moderate intensity respiratory strength training program applied early in the disease progression improved function in this C9orf72 ALS individual.
Expiratory Muscle Strength Training in patients After Total Laryngectomy; A Feasibility Pilot Study. [2022]Expiratory muscle strength training (EMST) is a threshold based device-driven treatment for improving expiratory pressure. EMST proved to be effective in different patient groups to improve cough function. To date, EMST has not been tested in the total laryngectomy population (TL).
Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. [2022]Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease affecting both upper and lower motor neurons, and lead to respiratory failure. Strategies are suggested to respiratory management in ALS patients, as the breath stacking and Expiratory muscle training (EMT), which have been used as aid to assist cough in neuromuscular disorders. However, the randomized controlled trials performed in ALS patients have not investigated the addiction of EMT together breath stacking in this population. This trial aims to determine if breath stacking plus EMT is more effective than breath stacking alone to decrease the decline rate on the inspiratory/expiratory muscle strength, FVC and voluntary PCF in ALS patients.
The Efficacy of Expiratory Muscle Training during Inspiratory Load in Healthy Adult Males: A Randomized Controlled Trial. [2023]This study aimed to evaluate the effects of expiratory muscle training (EMT) on respiratory muscle strength and respiratory distress during inspiratory load. Thirty-one healthy adult males were randomly divided into an EMT group who underwent EMT (n = 15) and a control group who did not undergo EMT (n = 16). The EMT group underwent EMT with a 50% load of maximum expiratory mouth pressure (PEmax) for 15 min, twice a day, every day, for 4 weeks. The parameter of respiratory muscle fatigue was a decrease in maximum inspiratory mouth pressure (PImax) and PEmax during 20 min of inspiratory load; thus, PImax and PEmax during inspiratory load were measured. Respiratory distress during inspiratory load was assessed using the Borg scale. These assessments were performed on the same subjects in each group before and after the 4 week study. In the EMT group, the PEmax values after the study were significantly higher than those before the study (p
POWERbreathe® Inspiratory Muscle Training in Amyotrophic Lateral Sclerosis. [2023]Inspiratory muscle training may benefit respiratory function, cardiocirculatory parameters, quality of life and functionality in neuromuscular diseases. This pilot study aimed to demonstrate the POWERbreathe® inspiratory muscle training effects on maximum inspiratory pressure (PImax), heart rate (HR) and HR variability, as well as the quality of life impairment and functionality in patients with Amyotrophic Lateral Sclerosis (ALS). A pilot single-blinded, non-randomized controlled clinical trial was carried out. A total of 20T ALS patients were enrolled and divided into experimental (n = 10) and control (n = 10) groups. The experimental group received POWERbreathe® inspiratory muscle training in conjunction with usual care, and the control group received only usual care for 8 weeks. PImax (measured by POWERbreathe® KH1), HR and HR variability (evaluated by Polar H7), quality of life impairment [measured by the Amyotrophic Lateral Sclerosis Assessment Questionnaire—40 items (ALSAQ-40)] and functionality [assessed by the ALS Functional Rating Scale Revised (ALSFRS-R)] were collected at baseline and after 8 weeks of intervention. We detected statistically significant differences (p
Respiratory Strength Training in Amyotrophic Lateral Sclerosis: A Double-Blind, Randomized, Multicenter, Sham-Controlled Trial. [2023]The objective of this study was to evaluate the short-term physiologic effect and one-year functional effect of a 12-week inspiratory and expiratory respiratory strength training (RST) program in individuals with amyotrophic lateral sclerosis (ALS).