Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-02 @ 2:24 AM
Study NCT ID:
NCT04320420
Status:
UNKNOWN
Last Update Posted:
2021-10-08
First Post:
2020-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autograft (APA²)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2020-03-20', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the feasibility of an adapted physical activity program surrounding an autograft', 'timeFrame': '6 months post-autograft', 'description': 'Proportion of patients performing all sessions offered per week and who performed exercises at home'}], 'secondaryOutcomes': [{'measure': 'To assess the impact of an adapted physical activity program on the number of patients with sarcopenia following an autograft', 'timeFrame': '6 months post-autograft', 'description': 'Number of patients with sarcopenia within 6 months of autograft'}, {'measure': 'To assess quality of life', 'timeFrame': '12 months post-autograft', 'description': 'Change in score of the Quality of Life Questionnaire (General, 30 questions) of European Organisation for the Research and Treatment of Cancer. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems'}, {'measure': 'To assess fatigue', 'timeFrame': '12 months post-autograft', 'description': 'Change in score of the multidimensional fatigue inventory questionnaire (20-100 with higher scores mean a worse outcome).'}, {'measure': 'To assess sexual function', 'timeFrame': '12 months post-autograft', 'description': 'Brief Index of Sexual Function for Women (5-75 with higher scores mean a better outcome).'}, {'measure': 'To assess sexual function', 'timeFrame': '12 months post-autograft', 'description': 'Male Sexual Health Questionnaire for men, Brief Index (5-125 with higher scores mean a better outcome).'}, {'measure': "To assess patient's satisfaction", 'timeFrame': '6 months post-autograft', 'description': 'Specific questionnaire for study (6-25 with higher scores mean a better outcome).'}, {'measure': 'To assess progression free survival', 'timeFrame': '28 months', 'description': 'Time between the inclusion date and the date of the first exam who show the progression of the disease'}, {'measure': 'To assess the response rate', 'timeFrame': '28 months', 'description': 'Number of patients with a partial or complete response according to Lugano criteria for lymphoma and IMWG (International Myeloma Working Group) for myeloma'}, {'measure': 'To assess the global physical activity load by patient and by session', 'timeFrame': '6 months post-autograft', 'description': 'Calculated by Foster method'}, {'measure': 'To assess the prevalence of endocrinal disorder', 'timeFrame': '28 months', 'description': 'Number of patients with endocrinal disorder between the date of inclusion and the date of end of study at the numerator and the number of patients following at the denominator'}, {'measure': "To assess the prevalence of autograft's complication", 'timeFrame': '28 months', 'description': "Number of patients with autograft's complication at the numerator and the number of patients following at the denominator"}, {'measure': 'To assess the duration and the cost of the hospitalization for the autograft', 'timeFrame': '6 months', 'description': 'Hospitalizations will be quote (economic data) by medical information department of center'}, {'measure': 'To assess the delay the period for resuming professional activity for the patients concerned, after the autograft', 'timeFrame': '28 months', 'description': 'Delay between the date of autograft and the date of resuming professional activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adapted Physical Activity', 'Autograft', 'Sarcopenia'], 'conditions': ['Myeloma', 'Lymphoma', 'Autologous Transplant']}, 'descriptionModule': {'briefSummary': 'Therapeutic intensification followed by an autograft of hematopoietic stem cells is a standard of care for young patients with myeloma from the first line and for lymphoma from the second or third line of treatment. This procedure remains toxic in the short and medium term with significant mortality and morbidity: the average mortality varies from 1.4 to 5%. The causes of death are linked to a severe infection, visceral bleeding or vital organ failure. This risk of mortality is partly correlated with sarcopenia.\n\nSarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.\n\nThe positive impact of adapted physical activity (APA) has been shown in numerous publications on reducing the incidence and risk of relapse for several cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on APA with different physical activity programs depending on the time of the intervention or according to the type, duration and intensity.\n\nThe objective of this study is to assess the feasibility of an APA program in patients requiring an autologous hematopoietic stem cell transplant. It is expected that the program will have a protective effect on the appearance of induced sarcopenia and on the complications related to the procedure in the short and medium term regardless of the hematology center for patients receiving intensive treatment with support for autologous hematopoietic stem cells.\n\nThis is a feasibility study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years,\n2. Patient with lymphoma or myeloma justifying an autograft of hematopoietic stem cells whatever the line of treatment,\n3. Patient affiliated to a social security scheme,\n4. Patient who has given written consent before any specific procedure related to the study\n\nExclusion Criteria:\n\n1. Central and / or peripheral neurological deficit not allowing adapted physical activity sessions to be carried out,\n2. Uncontrolled hypertension,\n3. Left ventricular Ejection Fraction \\<50%,\n4. Chronic respiratory insufficiency with alterations in the functional respiratory investigations,\n5. Active viral infection: hepatitis B, C and HIV,\n6. Pregnancy or breastfeeding,\n7. Persons deprived of their liberty or under guardianship\n8. Dementia, mental alteration or psychiatric pathology which could compromise the patient's informed consent and / or compliance with the protocol and follow-up of the trial,\n9. Patient who can't follow protocol for psychological, social, family or geographic reasons."}, 'identificationModule': {'nctId': 'NCT04320420', 'acronym': 'APA²', 'briefTitle': 'Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autograft (APA²)', 'organization': {'class': 'OTHER', 'fullName': 'Weprom'}, 'officialTitle': 'Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autologous Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'WP-2019-05'}, 'secondaryIdInfos': [{'id': '2019-A02203-54', 'type': 'OTHER', 'domain': 'French Health Products Safety Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'The APA program is defined in 3 stages:\n\nSTEP 1: during the initial chemotherapy over 3 months\n\n* 3 supervised APA sessions/week on site:\n\n * two muscle strengthening sessions, stretching, flexibility in the gym\n * a cardio session (Nordic Walking: outdoors)\n* at home: exercise book if the patient wishes\n\nSTEP 2: during hospitalization for the autograft, over 1 month:\n\n* 2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work\n* If the patient wishes, he can continue the exercises carried out with the APA engineer independently\n\nSTEP 3: after the transplant\n\n* the first 3 months:\n\n * 2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility),\n * 1-hour cardio session/week independently\n* the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions', 'interventionNames': ['Other: Adapted Physical Activity']}], 'interventions': [{'name': 'Adapted Physical Activity', 'type': 'OTHER', 'description': 'The APA program is defined in 3 stages:\n\nSTEP 1: during the initial chemotherapy over 3 months\n\n* 3 supervised APA sessions/week on site:\n\n * two muscle strengthening sessions, stretching, flexibility in the gym\n * a cardio session (Nordic Walking: outdoors)\n* at home: exercise book if the patient wishes\n\nSTEP 2: during hospitalization for the autograft, over 1 month:\n\n* 2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work\n* If the patient wishes, he can continue the exercises carried out with the APA engineer independently\n\nSTEP 3: after the transplant\n\n* the first 3 months:\n\n * 2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility),\n * 1-hour cardio session/week independently\n* the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aline SCHMITD, MD', 'role': 'CONTACT'}, {'name': 'Aline SCHMITD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'LE DU Katell, MD', 'role': 'CONTACT'}, {'name': 'Katell LE DU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Jean Bernard/Clinique Victor Hugo', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'centralContacts': [{'name': 'Magali BALAVOINE', 'role': 'CONTACT', 'email': 'm.balavoine@weprom.fr', 'phone': '241682940', 'phoneExt': '0033'}], 'overallOfficials': [{'name': 'Katell LE DU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Jean Bernard/Clinique Victor Hugo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weprom', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}