Remotely Supervised Exercise for Adults With Cystic Fibrosis

NCT05173194 | Completed

• 1 other identifier: FQKloE-II
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Exercise program; Lung funcion; Inflammation

Outcome Measures

Primary Outcomes (4)

• 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.

  Change from baseline to 8 weeks

  Baseline and 8 weeks

• Change in body composition (muscle mass and skeletal mass index - kg/m2) measured through dual-energy x-ray absorptiometry (DEXA)

  Change from baseline to 8 weeks

  Baseline and 8 weeks

• Change in plasmatic levels of Klotho

  Change from baseline to 8 weeks

  Baseline and 8 weeks

• Change in plasmatic levels of interleukins (IL-8 and IL-10)

  Change from baseline to 8 weeks

  Baseline and 8 weeks

Secondary Outcomes (4)

• Change in Pulmonary Function (Lung Function)

  Baseline and 8 weeks

• 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.

  Baseline and 8 weeks

• Change in inspiratory muscle strength (MIP)

  Baseline and 8 weeks

• Change in functional capacity (30 seconds sit-to-stand test)

  Baseline and 8 weeks

Study Arms (2)

Telematic Exercise

EXPERIMENTAL

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.

Other: Exercise

Control

NO INTERVENTION

Control group will follow routine recommendations from the multidisciplinary CF team.

Interventions

Exercise OTHER

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).

Telematic Exercise

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed clinical and genetic diagnosis for cystic fibrosis;
• Age from 16 years.

You may not qualify if:

• Musculoskeletal disorders that do not allow the performance of physical exercise;
• Pregnancy;
• Absence of registration of clinical required.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Hospital La Princesa

Madrid, 28006, Spain

Location

Related Publications (13)

• 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: 24480322 BACKGROUND

• 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: 30206131 BACKGROUND

• 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: 28965267 BACKGROUND

• 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: 24019231 BACKGROUND

• 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: 26981496 BACKGROUND

• 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: 26201096 BACKGROUND

• 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: 27140192 BACKGROUND

• 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: 29085059 BACKGROUND

• 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: 31027673 BACKGROUND

• 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: 31164040 BACKGROUND

• 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: 30023455 BACKGROUND

• 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: 23588193 BACKGROUND

• 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.

  PMID: 25002195 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Inflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Margarita Perez-Ruiz, PhD

  Universidad Politecnica de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluators of outcomes will be masked as for the study group of each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Exercise Physiology

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 29, 2021
• Study Start: October 26, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)