Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT04734561
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2020-12-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blind randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2020-12-31', 'studyFirstSubmitQcDate': '2021-01-30', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': 'Change from Baseline Health-related quality of life at 8 weeks', 'description': 'To evaluate the health-related quality of life of the participants a valid, reliable and generic questionnaire will be used. It consisted of five dimensions (Mobility, Self-care, Usual activities, Pain \\& discomfort, Anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.'}, {'measure': 'Exercise tolerance', 'timeFrame': 'Change from Baseline Exercise tolerance at 8 weeks', 'description': 'Exercise tolerance will be evaluated by a test consisted on 30 squats based on three different heart rate measuring moments (resting heart rate, heart rate after exercise, heart rate after longer period) evaluating the speed at which the heart rate increases/decreases.'}], 'secondaryOutcomes': [{'measure': 'Maximum respiratory pressures', 'timeFrame': 'Change from Baseline Maximum respiratory pressures at 8 weeks', 'description': 'The maximum respiratory pressures (MIP and MEP) will be measure with a device. This device applies an inspiratory/expiratory load which provides a resistance. The maneuver will be perform in a sitting position. Measuring a minimum of 3 times will be perform, recording the highest value.'}, {'measure': 'Inspiratory muscle endurance', 'timeFrame': 'Change from Baseline Inspiratory muscle endurance at 8 weeks', 'description': 'To measure inspiratory muscle endurance, The subjects inspire from a threshold valve beginning with pressures of 30% of MIP. The threshold pressure is then increased 10% of MIP until the load cannot be tolerated for 2 minutes. The maximum inspiratory mouth pressure that can be tolerated for the full 2-minute interval is considered the peak pressure (Ppeak)'}, {'measure': 'Upper limb muscle strength', 'timeFrame': 'Change from Baseline Peripheral muscle strength at 8 weeks', 'description': 'To measure peripheral muscle strength the isometric strength of the hand and forearm will be evaluated through a valid and reliable tool. Three separate tests will be administered for each arm and the highest value in kilograms will be recorded.'}, {'measure': 'Lung function (forced spirometry)', 'timeFrame': 'Change from Baseline Lung function at 8 weeks', 'description': 'The Spirometry will be perform according to American Thoracic Society criteria and was measured in liters. The maneuver will be perform 3 times and recording the best one.'}, {'measure': 'Cognitive factors', 'timeFrame': 'Change from Baseline cognitive factors at 8 weeks', 'description': 'A validated cognitive scale will be assessed in all study participants with acceptable psychometric properties to evaluate cognitive factors. Unit of Measure: Units on a Scale where higher values represent a greater impact.'}, {'measure': 'Lower limb muscle strength', 'timeFrame': 'Change from Baseline Lower limb strength at 8 weeks', 'description': 'A practical, reliable and valid field test consisted on to complete as many sit-to-stand cycles as possible on a chair during a frame time.'}, {'measure': 'Psychological factors', 'timeFrame': 'Change from Baseline Psychological factors at 8 weeks', 'description': 'A validated anxiety, depression and stress scale will be assessed in all study participants with acceptable psychometric properties to evaluate anxiety and stress factors. Unit of Measure: Units on a Scale where higher values represent a greater impact. These measurements will be aggregated to arrive at one reported value of the impact of Psychological factors.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Respiratory Muscle Training', 'Respiratory Function Test', 'Quality of Life', 'Psychosocial Factor'], 'conditions': ['Covid19', 'Respiratory Muscle Training', 'Respiratory Function Test', 'Quality of Life', 'Psychosocial Factor']}, 'referencesModule': {'references': [{'pmid': '32675661', 'type': 'BACKGROUND', 'citation': 'Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847.'}, {'pmid': '32475821', 'type': 'BACKGROUND', 'citation': "Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31."}, {'pmid': '32817258', 'type': 'BACKGROUND', 'citation': 'Spruit MA, Holland AE, Singh SJ, Tonia T, Wilson KC, Troosters T. COVID-19: interim guidance on rehabilitation in the hospital and post-hospital phase from a European Respiratory Society- and American Thoracic Society-coordinated international task force. Eur Respir J. 2020 Dec 3;56(6):2002197. doi: 10.1183/13993003.02197-2020. Print 2020 Dec.'}, {'pmid': '32220590', 'type': 'BACKGROUND', 'citation': 'Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.'}, {'pmid': '32379637', 'type': 'BACKGROUND', 'citation': 'Liu K, Zhang W, Yang Y, Zhang J, Li Y, Chen Y. Respiratory rehabilitation in elderly patients with COVID-19: A randomized controlled study. Complement Ther Clin Pract. 2020 May;39:101166. doi: 10.1016/j.ctcp.2020.101166. Epub 2020 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the present study is to observe the short-term effects of respiratory muscle training applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. As secondary objectives, the effects on respiratory muscles strength/tolerance, pulmonary function and psychological and cognitive factors.', 'detailedDescription': 'It is a double-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training, 2) Placebo Inspiratory muscle training, 3) Inspiratory muscle training + Expiratory muscle training, 4) Placebo Inspiratory muscle training + Expiratory muscle training.\n\nEach exercise training program will be applied twice per day 7 sessions per week during 8 weeks by a threshold device. The evening sessions will be supervised by a physiotherapist through a virtual platform.\n\nParticipants received baseline assessments at the beginning of the intervention, at the end of the 4th week, and post-intervention assessments at the end of the 8th week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive diagnosis of COVID-19 (SARS-CoV2)\n* Hospital admission for COVID-19 in the last 3 months\n* Stable phase and home discharge;\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Any type of musculoskeletal, neurological, cardiac or respiratory disease where training is contraindicated\n* Inability to carry out the training program through telematic supervision.'}, 'identificationModule': {'nctId': 'NCT04734561', 'briefTitle': 'Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Effects of Respiratory Muscle Training on Quality of Life, Physical and Pulmonary Function and Psychological Status in Patients Who Have Had COVID-19 Disease', 'orgStudyIdInfo': {'id': '20/715-E_BS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inspiratory muscle training group', 'description': 'Participants will perform an inspiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.', 'interventionNames': ['Other: Inspiratory muscle training group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Inspiratory muscle training placebo group', 'description': 'Participants will perform an inspiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.', 'interventionNames': ['Other: Inspiratory muscle training placebo group']}, {'type': 'EXPERIMENTAL', 'label': 'Inspiratory + expiratory muscle training group', 'description': 'Participants will perform an inspiratory and expiratory muscle training by a threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.', 'interventionNames': ['Other: Inspiratory + expiratory muscle training group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Inspiratory + expiratory muscle training placebo group', 'description': 'Participants will perform an inspiratory and expiratory muscle training by a placebo threshold device at home, twice a day for 8 weeks supervised by a physiotherapist through a virtual platform.', 'interventionNames': ['Other: Inspiratory + expiratory muscle training placebo group']}], 'interventions': [{'name': 'Inspiratory muscle training group', 'type': 'OTHER', 'description': 'Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.', 'armGroupLabels': ['Inspiratory muscle training group']}, {'name': 'Inspiratory muscle training placebo group', 'type': 'OTHER', 'description': 'Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.', 'armGroupLabels': ['Inspiratory muscle training placebo group']}, {'name': 'Inspiratory + expiratory muscle training group', 'type': 'OTHER', 'description': 'Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.', 'armGroupLabels': ['Inspiratory + expiratory muscle training group']}, {'name': 'Inspiratory + expiratory muscle training placebo group', 'type': 'OTHER', 'description': 'Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.', 'armGroupLabels': ['Inspiratory + expiratory muscle training placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'UComplutenseMadrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Ibai López de Uralde Villanueva, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid, Spain', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Ibai López de Uralde Villanueva', 'investigatorFullName': 'Ibai López de Uralde Villanueva', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}