Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 2:02 PM
Study NCT ID:
NCT05533034
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2022-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of lost to follow up patients', 'timeFrame': '3 months', 'description': 'Adherence to treatment'}, {'measure': 'Number of uncompleted questionnaires', 'timeFrame': '3 months', 'description': 'Adherence to treatment'}, {'measure': 'Amount of aerobic work recorded using a connected watch', 'timeFrame': '3 months', 'description': 'Adherence to treatment / Amount of aerobic work recorded using a connected watch with heart rate monitor'}, {'measure': 'Amount of exercises self-reported in a logbook', 'timeFrame': '3 months', 'description': 'Adherence to treatment'}, {'measure': 'Exercise Adherence Rating Scale (EARS) questionnaire', 'timeFrame': '3 months', 'description': 'Adherence to treatment / Amount of exercises'}, {'measure': 'Self-reported adherence', 'timeFrame': '3 months', 'description': 'Adherence to treatment'}, {'measure': 'Exercise Adherence Rating Scale (EARS) questionnaire', 'timeFrame': '3 months', 'description': 'Adherence to treatment'}, {'measure': 'Treatment burden assess by the Exercise Therapy Burden Questionnaire (ETBQ)', 'timeFrame': '3 months', 'description': 'Adherence to treatment / Burden of program'}, {'measure': 'Check-list to report side effects', 'timeFrame': '3 months', 'description': 'Adherence to treatment'}], 'secondaryOutcomes': [{'measure': 'Lung volume', 'timeFrame': 'Day of inclusion', 'description': 'Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months'}, {'measure': 'Lung volume', 'timeFrame': '3 months', 'description': 'Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months'}, {'measure': 'Diffusing capacity', 'timeFrame': 'Day of inclusion', 'description': 'Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months'}, {'measure': 'Diffusing capacity', 'timeFrame': '3 months', 'description': 'Pulmonary Function Testing (PFT) - Respiratory function / Variation between base line and 3 months'}, {'measure': 'Maximal oxygen consumption during a 6 minute walking test', 'timeFrame': 'Day of inclusion', 'description': 'Aerobic capacity / Variation between base line and 3 months'}, {'measure': 'Maximal oxygen consumption during a 6 minute walking test', 'timeFrame': '3 months', 'description': 'Aerobic capacity / Variation between base line and 3 months'}, {'measure': 'Saint Georges hospital questionnaire', 'timeFrame': 'Day of inclusion', 'description': 'Activity limitations specific to respiratory function / Variation between base line and 3 months'}, {'measure': 'Saint Georges hospital questionnaire', 'timeFrame': '3 months', 'description': 'Activity limitations specific to respiratory function / Variation between base line and 3 months'}, {'measure': 'Health Assessment Questionnaire (HAQ)', 'timeFrame': 'Day of inclusion', 'description': 'Overall activity limitations / Variation between base line and 3 months'}, {'measure': 'Health Assessment Questionnaire (HAQ)', 'timeFrame': '3 months', 'description': 'Overall activity limitations / Variation between base line and 3 months'}, {'measure': '12-Items short form survey questionnaire (SF-12)', 'timeFrame': 'Day of inclusion', 'description': 'Quality of life / Variation between base line and 3 months'}, {'measure': '12-Items short form survey questionnaire (SF-12)', 'timeFrame': '3 months', 'description': 'Quality of life / Variation between base line and 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Sclerosis', 'Lung disease', 'Rehabilitation', 'Respiratory deficiencies', 'Feasibility study'], 'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': "Systematic sclerosis (SSc) is a potentially severe disease characterized by various visceral involvements including lung. The investigators hypothesize that a respiratory rehabilitation program specifically designed for people with systematic sclerosis with early lung disease could help to decrease respiratory deficiencies, improve aerobic capacity and prevent activity limitations and participation restrictions.\n\nBefore testing the effectiveness of such a program, a pilot study is needed to assess its feasibility and optimize its content.\n\nParticipants will have 1 supervised session in the outpatient rehabilitation department. Each patient will then perform the home personalized exercises program for 3 months.\n\nThe feasibility of the program will be assessed at 3 months using patients' adherence to the program (assessed by the number of lost to follow-up, the number of questionnaires not completed, the amount of aerobic activity and the amount of home personalized exercises, treatment burden, adverse effects and quality of life.", 'detailedDescription': 'SSc is responsible for a reduced life expectancy. The prognosis depends on the presence of severe visceral damage and more particularly on the presence of interstitial lung damage, pulmonary arterial hypertension or specific cardiac damage which represent the 3 main causes of mortality in SSc.\n\nThe importance of rehabilitation in SSc has been confirmed by the latest INSERM Collective Expertise 2019). The objectives of functional rehabilitation in SSc are to prevent and/or reduce the specific (cutaneous, oral, cardiorespiratory, musculoskeletal) and non-specific (exercise deconditioning, fatigue, anxiety and depression) impairments frequently characterizing the evolution of the disease. Based on the latest practice recommendations for the diagnosis and treatment of idiopathic pulmonary fibrosis, people with a confirmed diagnosis of idiopathic pulmonary fibrosis and significant exercise and activity limitations should follow a respiratory rehabilitation program.\n\nThe value of a specific respiratory rehabilitation program for people with SSc is then a matter of interest. A pilot study is needed to assess the feasibility and optimize the content of a rehabilitation program. The investigators aimed to study the feasibility of a personalized home-based respiratory rehabilitation program in people with SSc with early lung disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemic sclerosis according to ACR/EULAR 2013 criteria\n* Lung involvement, with FCV \\> 70% on PFT\n\nExclusion Criteria:\n\n* Inability to understand French\n* Pregnancy or breastfeeding\n* Arterial pulmonary hypertension \\> 35 mmHg and unexplained dyspnoea or arterial pulmonary hypertension \\> 40 mmHg\n* Major musculoskeletal impairment incompatible with physical activity\n* other pulmonary disease decreasing FCV\n* Pathological EKG\n* Oxygen saturation at rest or during physical activity \\< 90%\n* FCV \\< 70%'}, 'identificationModule': {'nctId': 'NCT05533034', 'acronym': 'SCLERESPIR', 'briefTitle': 'Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Personalized Home Respiratory Rehabilitation Program for Subjects With Systemic Sclerosis With Early Lung Disease: Pilot Feasibility Study', 'orgStudyIdInfo': {'id': 'APHP210260'}, 'secondaryIdInfos': [{'id': '2020-A03551-38', 'type': 'OTHER', 'domain': 'France : ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home based exercises', 'description': '1 supervised session in the outpatient rehabilitation department with respiratory, aerobic and muscles strengthening exercises, followed by 3 months of self-manage personalized home exercises program. Cardiac frequency and adherence to exercise will be monitored using an activity tracker (Garmin© watch).', 'interventionNames': ['Other: Rehabilitation']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'otherNames': ['Personalized home exercises program'], 'description': '* 1 supervised session of rehabilitation, including a cardiac stress test (to define maximal intensity for aerobic activities), aerobic activity with interval training of moderate and progressive intensity (walking), and respiratory exercise using a volumetric spirometer, and strengthening exercises for lower and upper limbs.\n* 3 months of self-managed home exercises. Patients will be asked to use a tracker activity when performing home exercises to self-monitor cardiac frequency and to assess their adherence.', 'armGroupLabels': ['Home based exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandra ROREN', 'role': 'CONTACT', 'email': 'alexandra.roren@aphp.fr', 'phone': '0033158411371'}, {'name': 'Camille DASTE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Benjamin CHAIGNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Alexandra ROREN, PhD', 'role': 'CONTACT', 'email': 'alexandra.roren@aphp.fr', 'phone': '00 33 1 58 41 13 71'}, {'name': 'Marie BENHAMMANI-GODARD', 'role': 'CONTACT', 'email': 'marie.godard@aphp.fr', 'phone': '0033 1 58411190'}], 'overallOfficials': [{'name': 'Camille DASTE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)'}, {'name': 'Christelle NGUYEN, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}