Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-27 @ 11:46 AM
Study NCT ID:
NCT05003167
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhuber@purdue.edu', 'phone': '765-494-3796', 'title': 'Jessica Huber, Professor and PI', 'organization': 'Purdue University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The sample size was small. Participants enrolled in the current study likely had a preference or at least approval of telepractice prior to enrollment, since the recruitment materials stated that it was a telepractice study, and participants reached out to the researchers to express interest knowing that the study would be conducted through telepractice. Along similar lines, participants in the current study were highly educated and likely technologically savvy.'}}, 'adverseEventsModule': {'timeFrame': 'Over the course of the study (10 weeks for each participant)', 'description': 'No changes to definitions of adverse events. Participants rated breathlessness on a scale of 0-10 (no breathlessness to completed breathlessness) before and after estimating maximum expiratory pressure and the EMST training protocol. Participants were also interviewed weekly about issues with at home training and were observed in training once a week.', 'eventGroups': [{'id': 'EG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Post-treatment for Maximum Expiratory Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'Pre-training average', 'categories': [{'measurements': [{'value': '66.10', 'spread': '41.77', 'groupId': 'OG000'}]}]}, {'title': 'Post-training (week 10)', 'categories': [{'measurements': [{'value': '83.75', 'spread': '45.99', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.001', 'groupIds': ['OG000'], 'paramType': 'F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.48', 'groupDescription': 'A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)', 'description': 'Change in expiratory muscle strength throughout the study duration measured by the participant blowing into a pressure meter', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with baseline, pre-training, and post-treatment maximum expiratory pressure values were included. The second baseline and pre-training values were averaged to obtain the pre-training value which was used along with the week 10 value (post-treatment).'}, {'type': 'SECONDARY', 'title': 'Peak Expiratory Flow Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'Pre-training average', 'categories': [{'measurements': [{'value': '265.97', 'spread': '141.47', 'groupId': 'OG000'}]}]}, {'title': 'Post-training (week 10)', 'categories': [{'measurements': [{'value': '273.47', 'spread': '127.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10)', 'description': 'Change in cough strength (as measured by peak expiratory flow rate) throughout the study duration, measured using a flow meter that the participant coughs into - single coughs. Data from baseline 2 and pre-training were averaged for the pre--training value.', 'unitOfMeasure': 'liters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with baseline 2 (week 2) and pre-training values (week 3) and post-training (week 10) data were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-Treatment in Utterance Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'Baseline (reading) - week 1', 'categories': [{'measurements': [{'value': '10.76', 'spread': '3.29', 'groupId': 'OG000'}]}]}, {'title': 'Post-training (reading) - week 10', 'categories': [{'measurements': [{'value': '10.39', 'spread': '4.11', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.113', 'groupIds': ['OG000'], 'paramType': 'F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.29', 'groupDescription': 'A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 2,44'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'Change in utterance length (# of syllables produced on one breath) throughout the study duration. Participant read the Rainbow Passage and data were collected from this task.', 'unitOfMeasure': 'syllables', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had baseline and post-training values for this measure. Data from the first baseline and the week 10 post-treatment value were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-Treatment in Number of Pauses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'Baseline (reading) - week 1', 'categories': [{'measurements': [{'value': '15.89', 'spread': '8.28', 'groupId': 'OG000'}]}]}, {'title': 'Post-training (reading) - week 10', 'categories': [{'measurements': [{'value': '16.75', 'spread': '10.99', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.052', 'groupIds': ['OG000'], 'paramType': 'F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.17', 'groupDescription': 'A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'Change in the total number of pauses that included breathing (breath pauses). Participant read the Rainbow Passage and data were collected from this task.', 'unitOfMeasure': 'number of pauses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with baseline and post-training values. Data from the first baseline and the week 10 post-treatment value were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-Treatment in Syntactic Location of Pauses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'Baseline, major boundaries', 'categories': [{'measurements': [{'value': '47.12', 'spread': '37.59', 'groupId': 'OG000'}]}]}, {'title': 'Post-training, major boundaries', 'categories': [{'measurements': [{'value': '46.09', 'spread': '18.92', 'groupId': 'OG000'}]}]}, {'title': 'Baseline, boundaries unrelated to syntax', 'categories': [{'measurements': [{'value': '8.71', 'spread': '13.09', 'groupId': 'OG000'}]}]}, {'title': 'Post-training, boundaries unrelated to syntax', 'categories': [{'measurements': [{'value': '12.33', 'spread': '17.36', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.931', 'groupIds': ['OG000'], 'paramType': 'F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.07', 'groupDescription': 'A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.\n\nResults here are for percent of breaths at major boundaries.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.164', 'groupIds': ['OG000'], 'paramType': 'F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'groupDescription': 'A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05. Results reflect percent of breaths at boundaries unrelated to syntax.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'Change in the location of pauses while breathing produced while reading. We determined where participants took breaths while reading the Rainbow Passage and categorized them according to syntax. Categories included at a major boundary (at the end of an independent clause marked by a period) and at a boundary that is not related to syntax (not a major or minor syntactical location). The number of pauses at each category of boundaries were converted to a percent of the total breaths taken while reading the passage.', 'unitOfMeasure': 'percent of pauses at the boundary', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with baseline and post-training values. Data from baseline (week 1) and post-training (week 10) were used.'}, {'type': 'SECONDARY', 'title': 'Telehealth Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'categories': [{'measurements': [{'value': '60.58', 'spread': '7.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Training (week 10)', 'description': 'Participants rated 15 statements with a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Example statements include: I can easily talk to my health-care provider, I can hear my health-care provider clearly, I can see my health-care provider as if we met in person, I think the care provided via telemedicine is consistent, and I receive adequate attention, telemedicine provides for my health care need, and overall, I am satisfied with the quality of service being provided via telemedicine. Total scores range from 0-75 and individual statement scores ranged from 1-5, with higher scores indicating higher satisfaction with the telepractice modality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only assessed at post-training. Included all participants who completed the scale. Higher values reflect more satisfaction and the score maximum is 75.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-Training to Post-Training in Communication Participation Item Bank', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'pre-training (week 3)', 'categories': [{'measurements': [{'value': '47.78', 'spread': '15.96', 'groupId': 'OG000'}]}]}, {'title': 'post-training (week 10)', 'categories': [{'measurements': [{'value': '48.51', 'spread': '14.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Training (week 3) and Post-Training (week 10)', 'description': 'Participants were instructed to use a 4-point Likert scale (3: not at all; 2: a little; 1: quite a bit; 0: very much) to rate if/how their ALS impacts ten hypothetical communicative situations. Participants total scores were then added together, ranging from 0-30, and converted to a T-score ranging from 24.2-71.0. High scores are more favorable, indicating that the participant feels that ALS impacts their communicative participation less than those with lower scores.', 'unitOfMeasure': 'T-score scale points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with pre- and post-training scores. Data from the pre-training in week 3 and the week 10 post-treatment value were used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-Treatment in ALS Quality of Life Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'pre-training', 'categories': [{'measurements': [{'value': '5.97', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'post-training', 'categories': [{'measurements': [{'value': '5.94', 'spread': '0.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'The ALS Quality of Life Scale-Revised (ALSQOL-R) (Simmons, 2015) was used to measure how ALS impacts their quality of life in six domains: negative emotion, interaction with people and the environment, intimacy, religiosity, physical symptoms, and bulbar function. Participants rate whether they strongly disagree (0) or strongly agree (10) with 46 statements. Each domain score is given an average value between 0 (worse) and 10 (best). Total scores on the ALSQOL-R range from 0-460, but an average score ranging from 0-10 is computed by dividing the total score by the total number of items completed by the participant (usually 46). Higher scores reflect a higher quality of life. A survey assessing how each participant feels ALS impacts quality of life, and how that changes throughout the study duration. Total scores range from 0-460, with higher scores indicating greater contributions of ALS to quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with pre- and post-training scores on the scale. Lower scores reflect less effect of ALS on quality of life.'}, {'type': 'SECONDARY', 'title': 'ALS Function Rating Scale Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'title': 'Baseline (week 1)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '47'}]}]}, {'title': 'Post-training (week 10)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'A survey that quantifies change in disease progression throughout the study duration. Participants rate how 12 physical functions are impacted by their ALS. For each function, participants are provided with a 4-point Likert scale to rate whether they still have complete control of that function (4) or no ability to perform that function (0). Total scores range from 0 to 48, with lower scores indicating more severe symptoms and higher scores and less severe symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with baseline (week 1) and post-training (week 10) scores were included.'}, {'type': 'SECONDARY', 'title': 'Psychosocial Impact of Assistive Devices Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'categories': [{'measurements': [{'value': '28.08', 'spread': '26.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment (week 10)', 'description': "A survey assessing how the training device/modality impacts patient's psychosocial functions. The PIADS includes 12 items for competence, 6 for adaptability, and 8 for self-esteem. Participants use a 7-point Likert scale to rate the impact of a device on each item: a maximum negative impact (-3), somewhat negative impact (-2 or -1), zero impact (0), somewhat positive impact (1 or 2), maximum positive impact (3). Total scores range from -78 (maximum negative impact) to 78 (maximum positive impact).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a post-treatment (week 10) score.'}, {'type': 'SECONDARY', 'title': 'Tele-health Session Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'categories': [{'measurements': [{'value': '95.37', 'spread': '7.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the end of training across the entire training period', 'description': '% of training sessions scheduled and attended by participants throughout the study duration', 'unitOfMeasure': 'percentage of sessions attended', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the training protocol'}, {'type': 'SECONDARY', 'title': 'Adherence to Training Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'classes': [{'categories': [{'measurements': [{'value': '90.65', 'spread': '16.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured each week of training across the entire training duration', 'description': 'Number of of training exhalations completed (25 exhalations into the device, 5 days per week) by participants throughout the study duration', 'unitOfMeasure': 'percent of at-home training completed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).\n\nExpiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure)."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.46', 'spread': '8.63', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ALSFRS-R baseline', 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '3.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Amyotrophic Lateral Sclerosis Function Rating Scale-Revised (ALSFRS-R) (Cedarbaum et al., 1999) was used to assess overall physical functionality related to ALS. The survey requires participants to rate how 12 physical functions are impacted by their ALS (speech, salvation, swallowing, handwriting, etc). Participants are provided with a 4-point Likert scale to rate whether they still have complete control of that function (4) or no ability to perform that function (0). Total scores range from 0 to 48, with lower scores indicating more severe symptoms and higher scores and less severe symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Montreal Cognitive Assessment baseline', 'classes': [{'categories': [{'measurements': [{'value': '28.23', 'spread': '1.42', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Montreal Cognitive Assessment 4.1 (MoCA) (Nasreddine et al., 2005) was used to screen cognition for inclusion. Scores range from 0-30. Scores over 25 are considered to reflect cognition that is within normal limits.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-22', 'size': 403809, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-01-03T12:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants enrolled will receive the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2021-07-06', 'resultsFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-06', 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Post-treatment for Maximum Expiratory Pressure', 'timeFrame': 'Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)', 'description': 'Change in expiratory muscle strength throughout the study duration measured by the participant blowing into a pressure meter'}], 'secondaryOutcomes': [{'measure': 'Peak Expiratory Flow Rate', 'timeFrame': 'Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10)', 'description': 'Change in cough strength (as measured by peak expiratory flow rate) throughout the study duration, measured using a flow meter that the participant coughs into - single coughs. Data from baseline 2 and pre-training were averaged for the pre--training value.'}, {'measure': 'Change From Baseline to Post-Treatment in Utterance Length', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'Change in utterance length (# of syllables produced on one breath) throughout the study duration. Participant read the Rainbow Passage and data were collected from this task.'}, {'measure': 'Change From Baseline to Post-Treatment in Number of Pauses', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'Change in the total number of pauses that included breathing (breath pauses). Participant read the Rainbow Passage and data were collected from this task.'}, {'measure': 'Change From Baseline to Post-Treatment in Syntactic Location of Pauses', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'Change in the location of pauses while breathing produced while reading. We determined where participants took breaths while reading the Rainbow Passage and categorized them according to syntax. Categories included at a major boundary (at the end of an independent clause marked by a period) and at a boundary that is not related to syntax (not a major or minor syntactical location). The number of pauses at each category of boundaries were converted to a percent of the total breaths taken while reading the passage.'}, {'measure': 'Telehealth Satisfaction', 'timeFrame': 'Post-Training (week 10)', 'description': 'Participants rated 15 statements with a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Example statements include: I can easily talk to my health-care provider, I can hear my health-care provider clearly, I can see my health-care provider as if we met in person, I think the care provided via telemedicine is consistent, and I receive adequate attention, telemedicine provides for my health care need, and overall, I am satisfied with the quality of service being provided via telemedicine. Total scores range from 0-75 and individual statement scores ranged from 1-5, with higher scores indicating higher satisfaction with the telepractice modality.'}, {'measure': 'Change From Pre-Training to Post-Training in Communication Participation Item Bank', 'timeFrame': 'Pre-Training (week 3) and Post-Training (week 10)', 'description': 'Participants were instructed to use a 4-point Likert scale (3: not at all; 2: a little; 1: quite a bit; 0: very much) to rate if/how their ALS impacts ten hypothetical communicative situations. Participants total scores were then added together, ranging from 0-30, and converted to a T-score ranging from 24.2-71.0. High scores are more favorable, indicating that the participant feels that ALS impacts their communicative participation less than those with lower scores.'}, {'measure': 'Change From Baseline to Post-Treatment in ALS Quality of Life Scale', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'The ALS Quality of Life Scale-Revised (ALSQOL-R) (Simmons, 2015) was used to measure how ALS impacts their quality of life in six domains: negative emotion, interaction with people and the environment, intimacy, religiosity, physical symptoms, and bulbar function. Participants rate whether they strongly disagree (0) or strongly agree (10) with 46 statements. Each domain score is given an average value between 0 (worse) and 10 (best). Total scores on the ALSQOL-R range from 0-460, but an average score ranging from 0-10 is computed by dividing the total score by the total number of items completed by the participant (usually 46). Higher scores reflect a higher quality of life. A survey assessing how each participant feels ALS impacts quality of life, and how that changes throughout the study duration. Total scores range from 0-460, with higher scores indicating greater contributions of ALS to quality of life.'}, {'measure': 'ALS Function Rating Scale Revised', 'timeFrame': 'Baseline 1 (week 1) and Post-Training (week 10)', 'description': 'A survey that quantifies change in disease progression throughout the study duration. Participants rate how 12 physical functions are impacted by their ALS. For each function, participants are provided with a 4-point Likert scale to rate whether they still have complete control of that function (4) or no ability to perform that function (0). Total scores range from 0 to 48, with lower scores indicating more severe symptoms and higher scores and less severe symptoms.'}, {'measure': 'Psychosocial Impact of Assistive Devices Scale', 'timeFrame': 'Post-treatment (week 10)', 'description': "A survey assessing how the training device/modality impacts patient's psychosocial functions. The PIADS includes 12 items for competence, 6 for adaptability, and 8 for self-esteem. Participants use a 7-point Likert scale to rate the impact of a device on each item: a maximum negative impact (-3), somewhat negative impact (-2 or -1), zero impact (0), somewhat positive impact (1 or 2), maximum positive impact (3). Total scores range from -78 (maximum negative impact) to 78 (maximum positive impact)."}, {'measure': 'Tele-health Session Attendance', 'timeFrame': 'Measured at the end of training across the entire training period', 'description': '% of training sessions scheduled and attended by participants throughout the study duration'}, {'measure': 'Adherence to Training Protocol', 'timeFrame': 'Measured each week of training across the entire training duration', 'description': 'Number of of training exhalations completed (25 exhalations into the device, 5 days per week) by participants throughout the study duration'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'A tele-health treatment study for individuals with early stage ALS with the aim to improve communication, cough response, and respiratory strength. All participants complete a respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150) device from the comfort of their homes for 6 weeks.', 'detailedDescription': "The investigators are looking for people with early stage ALS to participate in a completely tele-health (no in-person visits required) treatment study examining the effects of an Expiratory Muscle Strength Training device (EMST-150) on communication, cough, and respiratory strength. Participants will be required to attend 2 virtual baseline assessment sessions followed by 12 additional virtual training sessions (2 per week for 6 weeks). Participants should plan to be actively enrolled in the study for \\~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training). Participants will also be required to fill out a series of questionnaires assessing the EMST's effectiveness via tele-health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ALS\n* Within the early stages of disease progression (i.e., able to talk, breathe, and eat independently)\n* Speaker of English\n* Have a family member/caregiver willing to assist as needed\n* Have access to an electronic device and internet for tele-health\n\nExclusion Criteria:\n\n* A history of neurological disease (besides ALS)\n* A history of asthma or respiratory problems (e.g., COPD, emphysema)\n* A history of head, neck, or chest surgery (except mastectomy)\n* A history of smoking within the last 5 years\n* Reliance on mechanical ventilation (including CPAP)'}, 'identificationModule': {'nctId': 'NCT05003167', 'briefTitle': 'Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS', 'orgStudyIdInfo': {'id': 'IRB-2020-524'}, 'secondaryIdInfos': [{'id': '1F31DC019281-01', 'link': 'https://reporter.nih.gov/quickSearch/1F31DC019281-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expiratory Muscle Strength Training', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).", 'interventionNames': ['Device: Expiratory Muscle Strength Training (EMST-150)']}], 'interventions': [{'name': 'Expiratory Muscle Strength Training (EMST-150)', 'type': 'DEVICE', 'description': "All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).", 'armGroupLabels': ['Expiratory Muscle Strength Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47906', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Jessica E Huber, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, SLHS', 'investigatorFullName': 'HuberLab', 'investigatorAffiliation': 'Purdue University'}}}}