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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Control group will follow routine recommendations from the multidisciplinary CF team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Function (Lung Function) | Change from baseline to 8 weeks | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margarita Perez-Ruiz, PhD | Universidad Politecnica de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Princesa | Madrid | 28006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24480322 | Background | 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. | |
| 30206131 |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Evaluators of outcomes will be masked as for the study group of each participant.
|
Change from baseline to 8 weeks |
| Baseline and 8 weeks |
| Change in inspiratory muscle strength (MIP) | Change from baseline to 8 weeks | Baseline and 8 weeks |
| Change in functional capacity (30 seconds sit-to-stand test) | Change from baseline to 8 weeks | Baseline and 8 weeks |
| 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. |
| 28965267 | 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. |
| 24019231 | 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. |
| 26981496 | 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. |
| 26201096 | 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. |
| 27140192 | 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. |
| 29085059 | 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. |
| 31027673 | 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. |
| 31164040 | 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. |
| 30023455 | 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. |
| 23588193 | 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. |
| 25002195 | 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |