Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06091358
Status:
UNKNOWN
Last Update Posted:
2023-11-30
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised parallel control group pilot investigation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Maximum heart rate during submaximal exercise test at week 4.', 'timeFrame': 'Baseline, and week 4', 'description': 'Maximum heart rate during submaximal exercise (bpm)'}, {'measure': 'Change in Blood pressure at week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'Blood pressure (mmhg)'}, {'measure': 'Change in Body mass index (BMI) at week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'Body mass index (BMI) (kg/m2)'}, {'measure': 'Change in Rating of perceived exertion (RPE) across submaximal exercise and 6 minute walk at week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'Rating of perceived exertion (RPE) (Borg)'}, {'measure': 'Change in Borg dyspnea scale across submaximal exercise and 6 minute walk at week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'Borg dyspnea scale'}, {'measure': 'Change in General health questionnaire (IPAQ) in week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'General health questionnaire (IPAQ)'}, {'measure': 'Change in Pittsburgh sleep quality index (PSQI) in week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'Pittsburgh sleep quality index (PSQI)'}, {'measure': 'Change in Post COVID-19 fatigue scale in week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'Post COVID-19 fatigue scale'}, {'measure': 'Change in EQ-5D-5L in week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'EQ-5D-5L (European Quality of Life)'}], 'primaryOutcomes': [{'measure': 'Change in Maximal inspiratory muscle pressure (MIP) at week 4.', 'timeFrame': 'Baseline, and week 4', 'description': 'Maximal inspiratory muscle pressure (cmH20)'}], 'secondaryOutcomes': [{'measure': 'Change in Peak expiratory flow (PEF) at week 4.', 'timeFrame': 'Baseline, and week 4', 'description': 'Peak expiratory flow (PEF) (l/min)'}, {'measure': 'Change in Ventilatory threshold (VT) at week 4.', 'timeFrame': 'Baseline, and week 4', 'description': 'Ventilatory threshold (VT)'}, {'measure': 'Difference between Baseline Dyspnea Index score (BDI) and Transitional Dyspnea index (TDI).', 'timeFrame': 'Baseline, and week 4', 'description': 'BDI and TDI'}, {'measure': 'Change in 6 minute walk test distance at week 4', 'timeFrame': 'Baseline, and week 4', 'description': '6 minute walk test difference (m)'}, {'measure': 'Change in Forced ventilatory equivalent 1 second (FEV1) at week 4', 'timeFrame': 'Baseline, and week 4', 'description': 'Forced ventilatory equivalent 1 second (FEV1) (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyspnea', 'Long COVID'], 'conditions': ['Long COVID']}, 'descriptionModule': {'briefSummary': 'This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention.', 'detailedDescription': 'The study design is a 4 - week parallel-arm intervention, randomised controlled trial. Participants will attend 2 testing days, baseline and follow-up 4 weeks apart.\n\nParticipants will first be screened over the phone to assess eligibility. Participants will then be randomly allocated using minimisation, into either control or intervention arm.\n\nBaseline testing:\n\nParticipants will undergo baseline testing in the laboratory.\n\nParticipants will be measured for their anthropometrics; height and weight. Participants will complete a series of questionnaires for 15 mins.\n\nFollowing 15 minutes rest, participants will then have three resting blood pressure and heart rate measurements and averaged via a sphygmomanometer and polar HR watch.\n\nMIP will be measured using the MicroRPM care fusion 3 times and the highest value reported (10 minutes). Forced expiratory value in 1 second (FEV1) and peak expiratory flow (PEF) will be measured using Vitalograph 700 (Spirotrac 6).\n\nParticipants will undergo a 6-minute-walk-test self-paced where Rating of perceived exertion (RPE) and Borg dyspnea scale (BDS) will be assessed each minute. Then a sub-maximal exercise test using a cycle ergometer and VyntusCPX, where Ventilatory threshold (VT) and Maximal heart rate (HRMax)will be measured. Participants will be asked to cycle until they reach a 17 RPE on a ramp test of 10-15W/min (\\>20mins). Heart rate (HR), Rating percieved exertion (RPE) and Borg dyspnea scale BDS) measured each minute.\n\nThe intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week. Participants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day. The control group will be asked to continue as normal throughout the 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.\n* Aged between 18 and 65\n\nExclusion Criteria:\n\n* Are pregnant\n* Receiving treatment following a previous cardiac event (Myocardial-infarction and Non-ST elevation MI),\n* Have a dementia diagnosis,\n* Have a high risk of falls,\n* Have an additional chronic respiratory disease diagnosis such as (Chronic obstructive pulmonary disease) COPD or CF (cystic fibrosis)\n* Are receiving respiratory muscle training\n* Are receiving steroid inhaler treatment'}, 'identificationModule': {'nctId': 'NCT06091358', 'briefTitle': 'Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': 'Does a 4-week Inspiratory Muscle Training Intervention (IMT) Increase Inspiratory Muscle Pressure (MIP) and Other Functional Outcomes in People With Long COVID? A Pilot Investigation', 'orgStudyIdInfo': {'id': 'MSES 22/23-013-A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17.\n\nParticipants continue usual life between baseline and follow up testing. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device.\n\nAfter 4 weeks, participants will return to the Laboratory and repeat baseline testing.'}, {'type': 'EXPERIMENTAL', 'label': 'Inspiratory Muscle training intervention', 'description': 'Participants will arrive at the Laboratory and complete a series of questionnaires: general physical activity, BDI, TDI, PSQI, General health questionnaire, Post COVID fatigue scale, EQ 5D-5L. They will undergo spirometry testing FEV1, MIP and PEF. Participants will undergo a 6 minute walk test and a Sub-maximal exercise test (CPET) using a cycle ergometer (15W/min) until an RPE of 17.\n\nParticipants undergo inspiratory muscle training for 4 weeks between baseline and follow up testing. They will be given a PrO2 device where the intervention will be 3 times per week for 4 weeks. Each session will be 6x6 breaths at 80% MIP. Participants will have 1 call per week where MIP is measured using a Care fusion hand held spirometer device.\n\nAfter 4 weeks, participants will return to the Laboratory and repeat baseline testing.', 'interventionNames': ['Device: PrO2']}], 'interventions': [{'name': 'PrO2', 'type': 'DEVICE', 'description': 'The intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week.\n\nParticipants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day each week.', 'armGroupLabels': ['Inspiratory Muscle training intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA2 7AY', 'city': 'Bath', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dylan Thompson, Phd', 'role': 'CONTACT', 'email': 'spsdt@bath.ac.uk', 'phone': '+44 (0) 1225 383448'}, {'name': 'James Betts, Phd', 'role': 'CONTACT', 'email': 'jb335@bath.ac.uk', 'phone': '+44 (0) 1225 383448'}], 'facility': 'The University of Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}], 'centralContacts': [{'name': 'Rachel Eddy', 'role': 'CONTACT', 'email': 're415@bath.ac.uk', 'phone': '00000000'}, {'name': 'Dylan Thompson', 'role': 'CONTACT', 'email': 'spsdt@bath.ac.uk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bath', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swansea University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Rachel Eddy', 'investigatorAffiliation': 'University of Bath'}}}}