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Kaartweergave
Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy (FIQMODE)
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De klinische studie NCT06322446 (FIQMODE) is een interventioneel studie bij Cystische fibrose met de status recruterend. Het doel is om 48 deelnemers te includeren vanaf 27 februari 2024. De studie wordt geleid door Universidad Politecnica de Madrid en de voltooiing is gepland op 23 december 2025. Laatste update op ClinicalTrials.gov: 21 maart 2024.
Beknopte samenvatting
Recently, the treatment of Cystic Fibrosis (CF) incorporated new modulators/enhancers of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR). It is thus increasingly important to study the side effects of these drugs, their extrapulmonary effects and possible interaction with other drugs and with exercise. For this purpose, a randomized controlled trial is proposed to determine the effects of a telematic exercise intervention on muscle health, in a group of 48 children and adolescents with CF treated with these new generation CFTR modulators. They will be randomly assigned to two groups (exercise and control group). The effect of the intervention will be analysed measuring the variables of muscle health, cardiorespiratory fitness, lung function, body composition, inflammatory biomarkers and miRNAs. After completion of the intervention program, adherence to exercise and clinical evolution after one year will be analysed.
Uitgebreide beschrijving
Specific objectives
- To determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis treated with new generation CFTR modulators on: (1.i) peripheral muscle strength; (1.ii) respiratory muscle strength; (1.iii) muscle mass and (1.iv) biomarkers of muscle damage.
- To determine the effects of a strength exercise intervention in a group of children and adolescents with cystic fibrosis being treated with new generation CFTR modulators on: (2.i) cardiorespiratory fitness; (2.ii) body composition and (2.iii) lung function.
- To determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with new-generation CFTR modulators on: (3.i) biomarkers of inflammatory status and (3.ii) expression of associated miRNAs.
- To determine the effects of a strength-based exercise intervention in a group of children and adolescents with cystic fibrosis treated with the new generation CFTR modulators on the levels of Elexaxcaftor/Ivacaftor/Tezacaftor and their metabolites.
- To assess the clinical evolution and adherence to exercise after 6 months of the programme in children and adolescents with cystic fibrosis treated with the new generation of CFTR modulators.
Officiële titel
Effects of a Strength Exercise Program on Muscular Health in People With CF Treated With Modulators of the Cystic Fibrosis Transmembrane Conductance Regulator Receptor (CFTR)
Aandoeningen
Cystische fibrosePublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:- Bell SC, Mall MA, Gutierrez H, Macek M, Madge S, Davies JC, Burgel PR, Tullis E, Castanos C, Castellani C, Byrnes CA, Cathcart F, Chotirmall SH, Cosgriff R, Eichler I, Fajac I, Goss CH, Drevinek P, Farrell PM, Gravelle AM, Havermans T, Mayer-Hamblett N, Kashirskaya N, Kerem E, Mathew JL, McKone EF, Naehrlich L, Nasr SZ, Oates GR, O'Neill C, Pypops U, Raraigh KS, Rowe SM, Southern KW, Sivam S, Stephenson AL, Zampoli M, Ratjen F. The future of cystic fibrosis care: a global perspective. Lancet Respir Med. 2020 Jan;8(1):65-124. doi: 10.1016/S2213-2600(19)30337-6. Epub 2019 Sep 27.
- Kerem B, Rommens JM, Buchanan JA, Markiewicz D, Cox TK, Chakravarti A, Buchwald M, Tsui LC. Identification of the cystic fibrosis gene: genetic analysis. Science. 1989 Sep 8;245(4922):1073-80. doi: 10.1126/science.2570460.
- Riordan JR, Rommens JM, Kerem B, Alon N, Rozmahel R, Grzelczak Z, Zielenski J, Lok S, Plavsic N, Chou JL, et al. Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science. 1989 Sep 8;245(4922):1066-73. doi: 10.1126/science.2475911.
- Rommens JM, Zengerling-Lentes S, Kerem B, Melmer G, Buchwald M, Tsui LC. Physical localization of two DNA markers closely linked to the cystic fibrosis locus by pulsed-field gel electrophoresis. Am J Hum Genet. 1989 Dec;45(6):932-41.
- Elborn JS. Cystic fibrosis. Lancet. 2016 Nov 19;388(10059):2519-2531. doi: 10.1016/S0140-6736(16)00576-6. Epub 2016 Apr 29.
- Bergeron C, Cantin AM. Cystic Fibrosis: Pathophysiology of Lung Disease. Semin Respir Crit Care Med. 2019 Dec;40(6):715-726. doi: 10.1055/s-0039-1694021. Epub 2019 Oct 28.
- Singh VK, Schwarzenberg SJ. Pancreatic insufficiency in Cystic Fibrosis. J Cyst Fibros. 2017 Nov;16 Suppl 2:S70-S78. doi: 10.1016/j.jcf.2017.06.011.
- Kamal N, Surana P, Koh C. Liver disease in patients with cystic fibrosis. Curr Opin Gastroenterol. 2018 May;34(3):146-151. doi: 10.1097/MOG.0000000000000432.
- Ratchford TL, Teckman JH, Patel DR. Gastrointestinal pathophysiology and nutrition in cystic fibrosis. Expert Rev Gastroenterol Hepatol. 2018 Sep;12(9):853-862. doi: 10.1080/17474124.2018.1502663. Epub 2018 Aug 3.
- Quinton PM. Cystic fibrosis: lessons from the sweat gland. Physiology (Bethesda). 2007 Jun;22:212-25. doi: 10.1152/physiol.00041.2006.
- Shteinberg M, Taylor-Cousar JL, Durieu I, Cohen-Cymberknoh M. Fertility and Pregnancy in Cystic Fibrosis. Chest. 2021 Dec;160(6):2051-2060. doi: 10.1016/j.chest.2021.07.024. Epub 2021 Jul 18.
- Reznikov LR. Cystic Fibrosis and the Nervous System. Chest. 2017 May;151(5):1147-1155. doi: 10.1016/j.chest.2016.11.009. Epub 2016 Nov 19.
- Khalaf M, Scott-Ward T, Causer A, Saynor Z, Shepherd A, Gorecki D, Lewis A, Laight D, Shute J. Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) in Human Lung Microvascular Endothelial Cells Controls Oxidative Stress, Reactive Oxygen-Mediated Cell Signaling and Inflammatory Responses. Front Physiol. 2020 Jul 29;11:879. doi: 10.3389/fphys.2020.00879. eCollection 2020.
- Tousson A, Van Tine BA, Naren AP, Shaw GM, Schwiebert LM. Characterization of CFTR expression and chloride channel activity in human endothelia. Am J Physiol. 1998 Dec;275(6):C1555-64. doi: 10.1152/ajpcell.1998.275.6.C1555.
- Plebani R, Tripaldi R, Lanuti P, Recchiuti A, Patruno S, Di Silvestre S, Simeone P, Anile M, Venuta F, Prioletta M, Mucilli F, Del Porto P, Marchisio M, Pandolfi A, Romano M. Establishment and long-term culture of human cystic fibrosis endothelial cells. Lab Invest. 2017 Nov;97(11):1375-1384. doi: 10.1038/labinvest.2017.74. Epub 2017 Jul 31.
- Totani L, Plebani R, Piccoli A, Di Silvestre S, Lanuti P, Recchiuti A, Cianci E, Dell'Elba G, Sacchetti S, Patruno S, Guarnieri S, Mariggio MA, Mari VC, Anile M, Venuta F, Del Porto P, Moretti P, Prioletta M, Mucilli F, Marchisio M, Pandolfi A, Evangelista V, Romano M. Mechanisms of endothelial cell dysfunction in cystic fibrosis. Biochim Biophys Acta Mol Basis Dis. 2017 Dec;1863(12):3243-3253. doi: 10.1016/j.bbadis.2017.08.011. Epub 2017 Aug 25.
- From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.
- Calella P, Valerio G, Brodlie M, Donini LM, Siervo M. Cystic fibrosis, body composition, and health outcomes: a systematic review. Nutrition. 2018 Nov;55-56:131-139. doi: 10.1016/j.nut.2018.03.052. Epub 2018 Apr 6.
Andere studie-ID's
- FIQMODE
- PI23/00299
NCT-ID
Startdatum (Werkelijk)
2024-02-27
Laatste update geplaatst
2024-03-21
Verwachte einddatum
2025-12-23
Inschrijving (Geschat)
48
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
Physical Fitness
Muscle Strength
Resistance Training
Lung funcion
Muscle Strength
Resistance Training
Lung funcion
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelIntervention Telematic Exercise:
A remotely supervised resistance exercise program will be carried out for 16 weeks, with two 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. | Oefening 16-week exercise intervention: At the beginning of the intervention, we will conduct a face-to-face familiarisation session with the exercises of the training programme. The intervention will consist of 2 sessions/week for 16 weeks. Each session consists of three stages: (i) Warm-up: 10 min of joint mobility and low intensity exercises involving the musculature to be worked in that session; (ii) Main part: circuit training mainly composed of strength exercises targeting the different muscle groups of the body and playing activities (iii) Cool down: 10 min with guided breathing work and stretching of the main muscle groups worked |
Geen interventieControl Control group will follow routine recommendations from the multidisciplinary CF team based on WHO´s guidelines | N.v.t. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Changes in peripheral muscle strength | Upper and lower limbs muscle strength (kg) will be evaluated using dynamometers. | Baseline, pre-intervention and immediately after the intervention. |
Changes in inspiratory/expiratory muscle strength (MIP/MEP) (cmH2O) | Inspiratory and expiratory muscle strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured. | Baseline, pre-intervention and immediately after the intervention |
Changes in functional capacity: lower limbs power capacity | 30 seconds sit-to-stand test. Unit of measurement: number of repetitions. | Baseline, pre-intervention and immediately after the intervention |
Changes in functional capacity: walking capacity | 10m Time (s) Up and Go tests. | Baseline, pre-intervention and immediately after the intervention |
Change in Cardiorespiratory fitness: maximal oxygen consumption | To assess cardiorespiratory fitness, a treadmill and a gas analyser will be used. The test aims to determine maximal oxygen consumption (VO2peak in ml/kg/min). VO2peak will be recorded as the highest value obtained during a continuous 30 s period. | Baseline, pre-intervention and immediately after the intervention |
Change in Cardiorespiratory fitness: Ventilatory threshold VT1 | To assess cardiorespiratory fitness, a treadmill and a gas analyser will be used. The test aims to determine the ventilatory threshold VT1 in response to maximal effort. VT1 will be determined using the criteria of an increase in both ventilatory equivalent for oxygen consumption (VE/VO2) and end-tidal oxygen pressure without an increase in ventilatory equivalent for carbon dioxide production (VE/VCO2). | Baseline, pre-intervention and immediately after the intervention |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Changes in Pulmonary Function: forced vital capacity (FVC) | Spirometry will assess: forced vital capacity (FVC) in milliliters and percentage of predicted value | Baseline, pre-intervention and immediately after the intervention |
Changes in Pulmonary Function: Forced expiratory volume in the first second (FEV1) | Spirometry will assess: forced expiratory volume in the first second (FEV1).Data will be expressed in absolute values and z-score based on the Global Lung Initiative (GLI) reference equation establishing as a limit of normality (LIN) a z-score value for FEV1 between -1.64 and + 1.64. | Baseline, pre-intervention and immediately after the intervention |
Changes in the anthropometric and body composition: Weight | Weight (kg) | Baseline, pre-intervention and immediately after the intervention |
Changes in the anthropometric and body composition: Height | Height (cm) | Baseline, pre-intervention and immediately after the intervention |
Changes in the anthropometric and body composition: BMI | BMI (kg/m2) | Baseline, pre-intervention and immediately after the intervention |
Changes in body composition: Total fat mass | Total fat mass (kg) | Baseline, pre-intervention and immediately after the intervention |
Changes in body composition: FMI | fat mass index (FMI) (kg/m2), | Baseline, pre-intervention and immediately after the intervention |
Changes in body composition: lean mass kg | Lean mass in kg | Baseline, pre-intervention and immediately after the intervention |
Changes in body composition: lean mass % | Lean mass in % | Baseline, pre-intervention and immediately after the intervention |
Changes in quality of life using the Cystic Fibrosis Questionnaire | Scores range from 0 to 100 with higher scores corresponding to better quality of life. | Baseline, pre-intervention and immediately after the intervention |
Changes in plasma levels muscle damage biomarkers | Blood levels biomarkers of muscle damage as CK measured in micrograms per litre (mcg/L) | Baseline, pre-intervention and immediately after the intervention |
Changes in plasma levels of inflammation: hs-CRP | High-sensitivity C-reactive protein (hs-CRP) assay in milligrams/litre | Baseline, pre-intervention and immediately after the intervention |
Changes in plasma levels of inflammation: Interleukins | Analysis of interleukins such as IL6, IL-10 in picograms/millilitre | Baseline, pre-intervention and immediately after the intervention |
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
6 Years
Geslachten die in aanmerking komen voor de studie
Allen
- patients diagnosed with CF.
- patients between 6-20 years of age.
- patients receiving treatment with new CFTR protein modulating medication
- reading, acceptance and signing of the informed consent form.
- CF patients with symptoms of pulmonary exacerbation during the last four weeks.
- with a diagnosis of other cardiorespiratory lung diseases progressing to a symptom of persistent respiratory dysfunction.
- CF patients with musculoskeletal alterations that influence assessments.
- CF patient who is pregnant during the time of the study
- CF patient with cognitive impairment;
- CF patient with incomplete dosing of modulator therapy;
Universidad Politecnica de Madrid- ⚕️Carlos III Health Institute
- 🏛️Universidad Europea de Madrid
- 🏥Hospital Universitario La Paz
- 🏥Hospital Universitario Ramon y Cajal
- 🏥Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Verantwoordelijke instantie
Margarita Pérez-Ruiz, Hoofdonderzoeker, full professor in Physical Activity and Health, Universidad Politecnica de Madrid
Centraal Contactpersoon
Contact: Margarita Pérez Ruiz, PhD, +34910677960, [email protected]
1 Studielocaties in 1 landen
Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM, Madrid, 28040, Spain
Marcela González Gross, PhD, Contact, +34910677980, [email protected]
Margarita M Pérez-Ruiz, PhD, Hoofdonderzoeker
Marcela González-Gross, PhD, Subonderzoeker
Recruterend