AzTrials
AzTrials

Cystic FibrosisFIQMODENCT06322446

Exercise in People With Cystic Fibrosis on CFTR Modulator Therapy

A study testing Exercise in people with Cystic Fibrosis, run by Universidad Politecnica de Madrid at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 20 years
Conditions the study is for
Cystic Fibrosis
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSpain
Study dates
27 Feb 2024to 4 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Facultad de Ciencias de la Actividad Física y Deporte - INEF UPM

    Madrid, Madrid, 28040

Other trials in Spain

About this study

Official title: 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)

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.

Read the detailed description

Specific objectives

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
Conditions
Cystic Fibrosis
Being tested
Exercise
Keywords
Physical Fitness, Muscle Strength, Resistance Training, Lung funcion
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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

Study groups in NCT06322446
Study groupRoleWhat they receive
InterventionExperimentalTelematic 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.
Receives: Other: Exercise
ControlNo interventionControl group will follow routine recommendations from the multidisciplinary CF team based on WHO´s guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in peripheral muscle strength

    Upper and lower limbs muscle strength (kg) will be evaluated using dynamometers.

    Measured: Baseline, pre-intervention and immediately after the intervention.

  2. 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.

    Measured: Baseline, pre-intervention and immediately after the intervention

  3. Changes in functional capacity: lower limbs power capacity

    30 seconds sit-to-stand test. Unit of measurement: number of repetitions.

    Measured: Baseline, pre-intervention and immediately after the intervention

  4. Changes in functional capacity: walking capacity

    10m Time (s) Up and Go tests.

    Measured: Baseline, pre-intervention and immediately after the intervention

  5. 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.

    Measured: Baseline, pre-intervention and immediately after the intervention

  6. 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).

    Measured: Baseline, pre-intervention and immediately after the intervention

Secondary outcomes (13)

  1. Changes in Pulmonary Function: forced vital capacity (FVC)

    Spirometry will assess: forced vital capacity (FVC) in milliliters and percentage of predicted value

    Measured: Baseline, pre-intervention and immediately after the intervention

  2. 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.

    Measured: Baseline, pre-intervention and immediately after the intervention

  3. Changes in the anthropometric and body composition: Weight

    Weight (kg)

    Measured: Baseline, pre-intervention and immediately after the intervention

  4. Changes in the anthropometric and body composition: Height

    Height (cm)

    Measured: Baseline, pre-intervention and immediately after the intervention

  5. Changes in the anthropometric and body composition: BMI

    BMI (kg/m2)

    Measured: Baseline, pre-intervention and immediately after the intervention

  6. Changes in body composition: Total fat mass

    Total fat mass (kg)

    Measured: Baseline, pre-intervention and immediately after the intervention

  7. Changes in body composition: FMI

    fat mass index (FMI) (kg/m2),

    Measured: Baseline, pre-intervention and immediately after the intervention

  8. Changes in body composition: lean mass kg

    Lean mass in kg

    Measured: Baseline, pre-intervention and immediately after the intervention

  9. Changes in body composition: lean mass %

    Lean mass in %

    Measured: Baseline, pre-intervention and immediately after the intervention

  10. 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.

    Measured: Baseline, pre-intervention and immediately after the intervention

  11. Changes in plasma levels muscle damage biomarkers

    Blood levels biomarkers of muscle damage as CK measured in micrograms per litre (mcg/L)

    Measured: Baseline, pre-intervention and immediately after the intervention

  12. Changes in plasma levels of inflammation: hs-CRP

    High-sensitivity C-reactive protein (hs-CRP) assay in milligrams/litre

    Measured: Baseline, pre-intervention and immediately after the intervention

  13. Changes in plasma levels of inflammation: Interleukins

    Analysis of interleukins such as IL6, IL-10 in picograms/millilitre

    Measured: Baseline, pre-intervention and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start27 Feb 2024
  3. Primary completion4 Jun 2026 (estimated)
  4. Study completion4 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06322446
Sponsor's protocol ID
PI23/00299
Acronym
FIQMODE
Status last verified
Apr 2026
First submitted
22 Feb 2024
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31570318

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 2589321

  • Elborn JS. Cystic fibrosis. Lancet. 2016 Nov 19;388(10059):2519-2531. doi: 10.1016/S0140-6736(16)00576-6. Epub 2016 Apr 29.

    PubMed 27140670

  • 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.

    PubMed 31659725

  • 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.

    PubMed 28986019

  • 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.

    PubMed 29438119

  • 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.

    PubMed 30019967

  • Quinton PM. Cystic fibrosis: lessons from the sweat gland. Physiology (Bethesda). 2007 Jun;22:212-25. doi: 10.1152/physiol.00041.2006.

    PubMed 17557942

  • 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.

    PubMed 34284004

  • 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.

    PubMed 27876591

  • 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.

    PubMed 32848840

  • 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.

    PubMed 9843717

  • 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.

    PubMed 28759010

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Cystic Fibrosis, run by Universidad Politecnica de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in peripheral muscle strength (time frame: Baseline, pre-intervention and immediately after the intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06322446, which also lists 55 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in