Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:35 AM
Study NCT ID:
NCT05173194
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2021-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remotely Supervised Exercise for Adults With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Evaluators of outcomes will be masked as for the study group of each participant.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peripheral muscle strength. Upper and lower limb muscle strength will be evaluated using the 5 maximum repetition test in specific strength machines. Handgrip strength will be measured with a dynamometer.', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}, {'measure': 'Change in body composition (muscle mass and skeletal mass index - kg/m2) measured through dual-energy x-ray absorptiometry (DEXA)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}, {'measure': 'Change in plasmatic levels of Klotho', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}, {'measure': 'Change in plasmatic levels of interleukins (IL-8 and IL-10)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Pulmonary Function (Lung Function)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}, {'measure': 'Change in quality of life evaluated using the Cystic Fibrosis Questionnaire (CFQ-R +14). Scores range from 0 to 100 with higher scores corresponding to better quality of life.', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}, {'measure': 'Change in inspiratory muscle strength (MIP)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}, {'measure': 'Change in functional capacity (30 seconds sit-to-stand test)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change from baseline to 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic fibrosis', 'Exercise program', 'Lung funcion', 'Inflammation'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '24480322', 'type': 'BACKGROUND', 'citation': 'van de Weert-van Leeuwen PB, Hulzebos HJ, Werkman MS, Michel S, Vijftigschild LA, van Meegen MA, van der Ent CK, Beekman JM, Arets HG. Chronic inflammation and infection associate with a lower exercise training response in cystic fibrosis adolescents. Respir Med. 2014 Mar;108(3):445-52. doi: 10.1016/j.rmed.2013.08.012. Epub 2013 Aug 28.'}, {'pmid': '30206131', 'type': 'BACKGROUND', 'citation': 'Vendrusculo FM, Heinzmann-Filho JP, da Silva JS, Perez Ruiz M, Donadio MVF. Peak Oxygen Uptake and Mortality in Cystic Fibrosis: Systematic Review and Meta-Analysis. Respir Care. 2019 Jan;64(1):91-98. doi: 10.4187/respcare.06185. Epub 2018 Sep 11.'}, {'pmid': '28965267', 'type': 'BACKGROUND', 'citation': 'Vandekerckhove K, Keyzer M, Cornette J, Coomans I, Pyl F, De Baets F, Schelstraete P, Haerynck F, De Wolf D, Van Daele S, Boone J. Exercise performance and quality of life in children with cystic fibrosis and mildly impaired lung function: relation with antibiotic treatments and hospitalization. Eur J Pediatr. 2017 Dec;176(12):1689-1696. doi: 10.1007/s00431-017-3024-7. Epub 2017 Sep 30.'}, {'pmid': '24019231', 'type': 'BACKGROUND', 'citation': 'Perez M, Groeneveld IF, Santana-Sosa E, Fiuza-Luces C, Gonzalez-Saiz L, Villa-Asensi JR, Lopez-Mojares LM, Rubio M, Lucia A. Aerobic fitness is associated with lower risk of hospitalization in children with cystic fibrosis. Pediatr Pulmonol. 2014 Jul;49(7):641-9. doi: 10.1002/ppul.22878. Epub 2013 Sep 9.'}, {'pmid': '26981496', 'type': 'BACKGROUND', 'citation': 'Mostafidi E, Moeen A, Nasri H, Ghorbani Hagjo A, Ardalan M. Serum Klotho Levels in Trained Athletes. Nephrourol Mon. 2016 Jan 9;8(1):e30245. doi: 10.5812/numonthly.30245. eCollection 2016 Jan.'}, {'pmid': '26201096', 'type': 'BACKGROUND', 'citation': 'Gao W, Yuan C, Zhang J, Li L, Yu L, Wiegman CH, Barnes PJ, Adcock IM, Huang M, Yao X. Klotho expression is reduced in COPD airway epithelial cells: effects on inflammation and oxidant injury. Clin Sci (Lond). 2015 Dec;129(12):1011-23. doi: 10.1042/CS20150273. Epub 2015 Jul 10.'}, {'pmid': '27140192', 'type': 'BACKGROUND', 'citation': 'Kureya Y, Kanazawa H, Ijiri N, Tochino Y, Watanabe T, Asai K, Hirata K. Down-Regulation of Soluble alpha-Klotho is Associated with Reduction in Serum Irisin Levels in Chronic Obstructive Pulmonary Disease. Lung. 2016 Jun;194(3):345-51. doi: 10.1007/s00408-016-9870-7. Epub 2016 May 2.'}, {'pmid': '29085059', 'type': 'BACKGROUND', 'citation': 'Krick S, Baumlin N, Aller SP, Aguiar C, Grabner A, Sailland J, Mendes E, Schmid A, Qi L, David NV, Geraghty P, King G, Birket SE, Rowe SM, Faul C, Salathe M. Klotho Inhibits Interleukin-8 Secretion from Cystic Fibrosis Airway Epithelia. Sci Rep. 2017 Oct 30;7(1):14388. doi: 10.1038/s41598-017-14811-0.'}, {'pmid': '31027673', 'type': 'BACKGROUND', 'citation': 'Amaro-Gahete FJ, de-la-O A, Jurado-Fasoli L, Gutierrez A, Ruiz JR, Castillo MJ. Association of physical activity and fitness with S-Klotho plasma levels in middle-aged sedentary adults: The FIT-AGEING study. Maturitas. 2019 May;123:25-31. doi: 10.1016/j.maturitas.2019.02.001. Epub 2019 Feb 5.'}, {'pmid': '31164040', 'type': 'BACKGROUND', 'citation': 'Amaro-Gahete FJ, De-la-O A, Jurado-Fasoli L, Espuch-Oliver A, de Haro T, Gutierrez A, Ruiz JR, Castillo MJ. Exercise training increases the S-Klotho plasma levels in sedentary middle-aged adults: A randomised controlled trial. The FIT-AGEING study. J Sports Sci. 2019 Oct;37(19):2175-2183. doi: 10.1080/02640414.2019.1626048. Epub 2019 Jun 4.'}, {'pmid': '30023455', 'type': 'BACKGROUND', 'citation': 'Amaro-Gahete FJ, De-la-O A, Jurado-Fasoli L, Espuch-Oliver A, Robles-Gonzalez L, Navarro-Lomas G, de Haro T, Femia P, Castillo MJ, Gutierrez A. Exercise training as S-Klotho protein stimulator in sedentary healthy adults: Rationale, design, and methodology. Contemp Clin Trials Commun. 2018 May 18;11:10-19. doi: 10.1016/j.conctc.2018.05.013. eCollection 2018 Sep.'}, {'pmid': '23588193', 'type': 'BACKGROUND', 'citation': 'Kriemler S, Kieser S, Junge S, Ballmann M, Hebestreit A, Schindler C, Stussi C, Hebestreit H. Effect of supervised training on FEV1 in cystic fibrosis: a randomised controlled trial. J Cyst Fibros. 2013 Dec;12(6):714-20. doi: 10.1016/j.jcf.2013.03.003. Epub 2013 Apr 13.'}, {'pmid': '25002195', 'type': 'BACKGROUND', 'citation': 'Rovedder PM, Flores J, Ziegler B, Casarotto F, Jaques P, Barreto SS, Dalcin Pde T. Exercise programme in patients with cystic fibrosis: a randomized controlled trial. Respir Med. 2014 Aug;108(8):1134-40. doi: 10.1016/j.rmed.2014.04.022. Epub 2014 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'Cystic fibrosis (CF) is a genetic disease characterized by abnormal chloride transport in epithelial tissues. Inflammation is a key component contributing to the main alterations induced by the disease. The increase in life expectancy comes with a higher prevalence of CF-related comorbidities, but also with new emerging complications directly related to aging. Physical fitness and exercise practice have been previously associated to survival and better quality of life in patients with cystic fibrosis. Thus, the aim of this study is to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.', 'detailedDescription': 'This study aims to assess the effects of a remotely supervised resistance exercise program on lung function, muscle strength, body composition, quality of life and inflammatory markers in adult patients with cystic fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed clinical and genetic diagnosis for cystic fibrosis;\n* Age from 16 years.\n\nExclusion Criteria:\n\n* Musculoskeletal disorders that do not allow the performance of physical exercise;\n* Pregnancy;\n* Absence of registration of clinical required.'}, 'identificationModule': {'nctId': 'NCT05173194', 'briefTitle': 'Remotely Supervised Exercise for Adults With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Effects of a Remotely Supervised Exercise Program on Inflammatory Markers, Muscle Strength and Lung Function in Adult Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'FQKloE-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telematic Exercise', 'description': 'A remotely supervised resistance exercise program will be carried out for 8 weeks, with three weekly sessions lasting approximately 60 minutes each. Training will be performed in groups of four patients, according to their lung function/physical fitness. The first training session will be on site (University) for familiarization, planning and adjustment of the exercises, and the following sessions will be performed online. Each session is divided into: (i) Warm-up and joint mobility; (ii) main part: strength exercises for different muscle groups; and (iii) cool down: stretching and breathing exercises.', 'interventionNames': ['Other: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group will follow routine recommendations from the multidisciplinary CF team.'}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Eight-week program of a remotely supervised resistance exercise. Frequency: three times per week. Duration: 60 minutes per session. Training program: warm-up and joint mobility; strength exercises for different muscle groups; and cool down (stretching and breathing exercises).', 'armGroupLabels': ['Telematic Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Margarita Perez-Ruiz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Politecnica de Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Exercise Physiology', 'investigatorFullName': 'Margarita Perez', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}