Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06952127
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Preliminary Efficacy of a Group-based Telerehabilitation Program in People With Post-COVID-19 Sequelae (TEPCO).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The feasibility of study procedures', 'timeFrame': '8 weeks', 'description': 'This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % of participants who drop out or withdraw from a study (attrition rate), % completed session (adherence rate); number of adverse events and % of participants satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Exercise capacity', 'timeFrame': '8 weeks', 'description': 'Pedaling time on a cycle ergometer at constant load (i.e., 60% of maximum load).'}, {'measure': 'Walking capacity', 'timeFrame': '8 weeks', 'description': '6-minute walk test Total distance walked in meters'}, {'measure': 'Lower-limb endurance', 'timeFrame': '8 weeks', 'description': '1-minute sit-to-stand test The number of completed sit-to-stand repetitions is record.'}, {'measure': 'Physical performance', 'timeFrame': '8 weeks', 'description': 'Short Physical Performance Battery test Is made up of a set of three tests: standing static balance in three positions (score 0-4); lower limb strength and power through getting up and sitting on a chair(score 0-4); and walking speed at normal pace (score 0-4). And an overall score on 12.'}, {'measure': 'Change in Independence in activities of daily living', 'timeFrame': '8 weeks', 'description': 'The Barthel Index Ten items are scored with a number of points (the scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent), and then a final score is calculated by summing the points awarded to each functional skill. The higher the score, the more independent the patient is.'}, {'measure': 'Change in Clinical Frailty', 'timeFrame': '8 weeks', 'description': 'Clinical Frailty Scale (CFS) Frailty score ranging from 1 (very fit) to 9 (terminally ill)'}, {'measure': 'Change in Quality of life', 'timeFrame': '8 weeks', 'description': "Saint George's Hospital Respiratory Questionnaire (SGHRQ). Scores ranging from 0 to 100 are calculated for each component, as well as a total score that summarizes the responses to all items. A zero score indicates no impairment of quality of life, and higher scores indicate more limitations."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['telerehabilitation'], 'conditions': ['Long COVID-19 Syndrome', 'Long COVID', 'Long COVID Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this study pilot randomized controlled study is to evaluate the feasibility of the study procedures and to compare the preliminary efficacy of a rehabilitation program given in a "remote" (telerehabilitation) or "face-to-face" model for adult patients who had confirmed SARS-CoV-2 infection and still have symptoms after eight weeks of infection. The main question it aims to answer is:\n\n* Are the study procedures feasible?\n* Will the two groups have similar results for the preliminary efficacy outcomes?\n\nResearchers will compare group telerehabilitation to a face-to-face group to see if it\'s comparable.\n\nParticipants will:\n\n* Take part in a 60-minute training session, 3 times a week in person or remotely\n* Visit the clinic before starting the training program and after 8 weeks of training\n* Keep a diary of their symptoms, if any'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (≥18 years)\n* confirmed SARS-CoV-2 infection defined by positive polymerase chain reaction (PCR) testing and/or antigen test results\n* referred to the pneumology clinic for a modified British Medical Research Council (mMRC) dyspnea score of 2-3 after a minimum of eight weeks of infection\n* VO₂max of less than 80% of the predicted value\n* receiving a medical prescription for rehabilitation following initial assessment by a pulmonologist\n* being able to walk independently\n* providing informed consent\n* having a good internet connection (i.e., a minimum download speed of 4 Mbps and an upload speed of 4 Mbps)\n* being in possession of a computer or tablet equipped with a camera enabling videoconferencing.\n\nExclusion Criteria:\n\n* requiring in-hospital rehabilitation at discharge\n* evidence of medical instability (i.e., moderate or severe cardiac disease, ischemic or severe hemorrhagic stroke, or neurodegenerative disease, unstable fracture)\n* history of severe cognitive or mental impairment\n* already enrolled in another rehabilitation program'}, 'identificationModule': {'nctId': 'NCT06952127', 'acronym': 'TEPCO', 'briefTitle': 'Feasibility and Preliminary Efficacy of a Group-based Telerehabilitation Program in People With Post-COVID-19 Sequelae (TEPCO).', 'organization': {'class': 'OTHER', 'fullName': 'Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec'}, 'officialTitle': 'Pilot Study Evaluating the Feasibility and Appropriateness of a Telerehabilitation Exercise Program in People With Post-COVID-19 Sequelae: a Single-center Randomized Trial.', 'orgStudyIdInfo': {'id': '2023-667'}, 'secondaryIdInfos': [{'id': '889', 'type': 'REGISTRY', 'domain': 'Base de données des projets de recherche du CIUSSS-MCQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation group', 'description': 'Rehabilitation program including cardiovascular, muscular and balance training and, if necessary, respiratory physiotherapy using the Teams platform supervised by a certified kinesiologist. The rehabilitation will be conducted 3 times a week for 8 weeks in group of 5 or 6 persons.', 'interventionNames': ['Other: Rehabilitation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Face-to-face group', 'description': 'Rehabilitation program including cardiovascular, muscular and balance training and, if necessary, respiratory physiotherapy at the university kinesiology clinic supervised by a certified kinesiologist. The rehabilitation will be conducted 3 times a week for 8 weeks in group of 5 or 6 persons.', 'interventionNames': ['Other: Rehabilitation program']}], 'interventions': [{'name': 'Rehabilitation program', 'type': 'OTHER', 'description': '* 5-minute warm-up including easy global exercises\n* 5 resistance training exercises targeting upper and lower muscle groups\n* 30 secondes break between sets\n* Cooldown with breathing and stretching exercises', 'armGroupLabels': ['Face-to-face group', 'Telerehabilitation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G8Z 3R9', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre hospitalier affilié universitaire régional', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marie-Claude Lehoux', 'investigatorAffiliation': 'Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec'}}}}