Remotely Supervised Exercise for Adults With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Effects of a Remotely Supervised Exercise Program on Inflammatory Markers, Muscle Strength and Lung Function in Adult Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173194
• Other study ID #: FQKloE-II
• Status: Completed
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2023
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Confirmed clinical and genetic diagnosis for cystic fibrosis;

• Age from 16 years.

Exclusion Criteria:

• Musculoskeletal disorders that do not allow the performance of physical exercise;

• Pregnancy;

• Absence of registration of clinical required.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Exercise
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).

Locations

Country	Name	City	State
Spain	Hospital La Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (13)

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. — View 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. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100688. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in plasmatic levels of Klotho	Change from baseline to 8 weeks	Baseline and 8 weeks
Primary	Change in plasmatic levels of interleukins (IL-8 and IL-10)	Change from baseline to 8 weeks	Baseline and 8 weeks
Secondary	Change in Pulmonary Function (Lung Function)	Change from baseline to 8 weeks	Baseline and 8 weeks
Secondary	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.	Change from baseline to 8 weeks	Baseline and 8 weeks
Secondary	Change in inspiratory muscle strength (MIP)	Change from baseline to 8 weeks	Baseline and 8 weeks
Secondary	Change in functional capacity (30 seconds sit-to-stand test)	Change from baseline to 8 weeks	Baseline and 8 weeks