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| ID | Type | Description | Link |
|---|---|---|---|
| 0560-N-22 | Other Identifier | PEIBA. Junta de AndalucÃa. Government of Spain. |
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| Name | Class |
|---|---|
| Universidad Pablo de Olavide | OTHER |
| Hospital Universitario de Valme | OTHER |
| Andaluz Health Service | OTHER_GOV |
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Occlusive training in people with fibromyalgia
Intervention study in people with fibromyalgia with the implementation of a lower body occlusive tool in aerobic exercise. The study aims to descriptively test the impact on quality of life and functional autonomy of occlusive training in a controlled and individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Aerobic exercise plus occlusive tool. | Experimental | Performing low-impact aerobic exercise with an occlusive tool 2 days per week. |
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| Group 2: Aerobic exercise without occlusive tool. | No Intervention | Performing low-impact aerobic exercise without an occlusive tool 2 days per week. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlusion training | Device | Impact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Coenzyme Q10 after a 9-week intervention period. | Coenzyme Q10 | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in total antioxidants after a 9-week intervention period. | TAS | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in disease impact questionnaire WPI after a 9-week intervention period. | WPI; score between (0-19). The higher the score, the greater the impact of the disease. | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in disease impact questionnaire SSscore after a 9-week intervention period. | SS score; score between (0-3) in the first half. Score between (0-40); between 1-10 (1 point), between 11-24 (2 points), more than 25 (3 points) in the second half. The higher the score, the greater the impact of the disease. | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in disease impact questionnaire FIQ after a 9-week intervention period. | FIQ; score between (0-100). The higher the score, the greater the impact of the disease | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in disease impact questionnaire MFI-20 after a 9-week intervention period. | MFI-20; (0-60) no fatigue. (60-70), fatigue, lighter or more severe, depending on the depending on the rating closer to 60 or 70 points. (more than 70 points), severe fatigue. |
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Inclusion Criteria:
A patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (American Rheumatology Association). Wolfe et al., (2010).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Carlos RodrÃguez Bautista, PhD currently | Universidad Pablo de Olavide | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Pablo de Olavide | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25617055 | Background | Latorre-Roman PA, Segura-Jimenez V, Aparicio VA, Santos E Campos MA, Garcia-Pinillos F, Herrador-Colmenero M, Alvarez-Gallardo IC, Delgado-Fernandez M. Ageing influence in the evolution of strength and muscle mass in women with fibromyalgia: the al-Andalus project. Rheumatol Int. 2015 Jul;35(7):1243-50. doi: 10.1007/s00296-015-3213-5. Epub 2015 Jan 24. | |
| 26986947 |
| Label | URL |
|---|---|
| 30-second chair stand | View source |
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Numeric code to each participant, concealing their personal data at all times.
The protocol before the start and the numerical codes at the end of the intervention period.
Shared use only from principal investigator with collaborating investigators of the study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 | Jul 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
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| Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in high density lipoproteins after a 9-week intervention period. | HDL | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in low density lipoproteins after a 9-week intervention period. | LDL | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in total cholesterol lipoproteins after a 9-week intervention period. | CHOL | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in triglycerides after a 9-week intervention period. | TG | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Changes in urea after a 9-week intervention period. | Urea | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Changes in creatinine after a 9-week intervention period. | Creatinine | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in gamma-glutamyl transferase after a 9-week intervention period. | GGT | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in glutamic-pyruvic transaminase after a 9-week intervention period. | GPT | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period. | GOT | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in alkaline phosphatase after a 9-week intervention period. | ALP | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in funcional test after a 9-week intervention period. | 6-minute walking test | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period) |
| Change in funcional test after a 9-week intervention period. | incremental shuttle walking test | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period) |
| Change in funcional test after a 9-week intervention period. | 30 second chair and stand test | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in funcional test after a 9-week intervention period. | Time and go test | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period) |
| Change in malondialdehyde after a 9-week intervention period. | MDA (malondialdehyde) | Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). |
| Change in distance traveled after a 9-week intervention period. | Pedometer registration. Immediately after each session from week 1 to 9 of the intervention period. With a total of 18 recordings over the 9 weeks of the intervention period. | From week 1 to week 9 of the intervention period. |
| Change in visual pain scale VAS over a 9-week intervention period. | Visual pain scale (1-10). 1 being lighter and 10 being more severe. Visual pain scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period. | From week 1 to week 9 of the intervention period. |
| Change in perceived exertion scale BORG over a 9-week intervention period. | Perceived exertion scale. (1-10). 1 being lighter and 10 being more severe. Perceived exertion scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period. | From week 1 to week 9 of the intervention period. |
| Bonaterra GA, Then H, Oezel L, Schwarzbach H, Ocker M, Thieme K, Di Fazio P, Kinscherf R. Morphological Alterations in Gastrocnemius and Soleus Muscles in Male and Female Mice in a Fibromyalgia Model. PLoS One. 2016 Mar 17;11(3):e0151116. doi: 10.1371/journal.pone.0151116. eCollection 2016. |
| 11842825 | Background | Valim V, Oliveira LM, Suda AL, Silva LE, Faro M, Neto TL, Feldman D, Natour J. Peak oxygen uptake and ventilatory anaerobic threshold in fibromyalgia. J Rheumatol. 2002 Feb;29(2):353-7. |
| 26142171 | Background | Koca I, Savas E, Ozturk ZA, Boyaci A, Tutoglu A, Alkan S, Yildiz H, Kimyon G. The evaluation in terms of sarcopenia of patients with fibromyalgia syndrome. Wien Klin Wochenschr. 2016 Nov;128(21-22):816-821. doi: 10.1007/s00508-015-0821-8. Epub 2015 Jul 4. |
| 23116302 | Background | Shang Y, Gurley K, Symons B, Long D, Srikuea R, Crofford LJ, Peterson CA, Yu G. Noninvasive optical characterization of muscle blood flow, oxygenation, and metabolism in women with fibromyalgia. Arthritis Res Ther. 2012 Nov 1;14(6):R236. doi: 10.1186/ar4079. |
| 24610539 | Background | Sarifakioglu B, Guzelant AY, Guzel EC, Guzel S, Kiziler AR. Effects of 12-week combined exercise therapy on oxidative stress in female fibromyalgia patients. Rheumatol Int. 2014 Oct;34(10):1361-7. doi: 10.1007/s00296-014-2978-2. Epub 2014 Mar 9. |
| 20417529 | Background | Cordero MD, de Miguel M, Moreno-Fernandez AM. [Mitochondrial dysfunction in fibromyalgia and its implication in the pathogenesis of disease]. Med Clin (Barc). 2011 Mar 12;136(6):252-6. doi: 10.1016/j.medcli.2010.01.030. Epub 2010 Apr 24. Spanish. |
| 14962957 | Background | Sprott H, Salemi S, Gay RE, Bradley LA, Alarcon GS, Oh SJ, Michel BA, Gay S. Increased DNA fragmentation and ultrastructural changes in fibromyalgic muscle fibres. Ann Rheum Dis. 2004 Mar;63(3):245-51. doi: 10.1136/ard.2002.004762. |
| 23600892 | Background | Castro-Marrero J, Cordero MD, Saez-Francas N, Jimenez-Gutierrez C, Aguilar-Montilla FJ, Aliste L, Alegre-Martin J. Could mitochondrial dysfunction be a differentiating marker between chronic fatigue syndrome and fibromyalgia? Antioxid Redox Signal. 2013 Nov 20;19(15):1855-60. doi: 10.1089/ars.2013.5346. Epub 2013 May 29. |
| 19268526 | Background | Emerling BM, Weinberg F, Snyder C, Burgess Z, Mutlu GM, Viollet B, Budinger GR, Chandel NS. Hypoxic activation of AMPK is dependent on mitochondrial ROS but independent of an increase in AMP/ATP ratio. Free Radic Biol Med. 2009 May 15;46(10):1386-91. doi: 10.1016/j.freeradbiomed.2009.02.019. Epub 2009 Mar 3. |
| 16809770 | Background | Laderoute KR, Amin K, Calaoagan JM, Knapp M, Le T, Orduna J, Foretz M, Viollet B. 5'-AMP-activated protein kinase (AMPK) is induced by low-oxygen and glucose deprivation conditions found in solid-tumor microenvironments. Mol Cell Biol. 2006 Jul;26(14):5336-47. doi: 10.1128/MCB.00166-06. |
| 27781288 | Background | Collado-Mateo D, Dominguez-Munoz FJ, Adsuar JC, Merellano-Navarro E, Olivares PR, Gusi N. Reliability of the Timed Up and Go Test in Fibromyalgia. Rehabil Nurs. 2018 Jan/Feb;43(1):35-39. doi: 10.1002/rnj.307. |
| 26878719 | Background | Heredia-Jimenez J, Latorre-Roman P, Santos-Campos M, Orantes-Gonzalez E, Soto-Hermoso VM. Spatio-temporal gait disorder and gait fatigue index in a six-minute walk test in women with fibromyalgia. Clin Biomech (Bristol). 2016 Mar;33:1-6. doi: 10.1016/j.clinbiomech.2016.01.009. Epub 2016 Feb 2. |
| 14635298 | Background | Pankoff BA, Overend TJ, Lucy SD, White KP. Reliability of the six-minute walk test in people with fibromyalgia. Arthritis Care Res. 2000 Oct;13(5):291-5. doi: 10.1002/1529-0131(200010)13:53.0.co;2-x. |
| 31899457 | Background | Salvi D, Poffley E, Orchard E, Tarassenko L. The Mobile-Based 6-Minute Walk Test: Usability Study and Algorithm Development and Validation. JMIR Mhealth Uhealth. 2020 Jan 3;8(1):e13756. doi: 10.2196/13756. |
| 22031349 | Background | Wevers LE, Kwakkel G, van de Port IG. Is outdoor use of the six-minute walk test with a global positioning system in stroke patients' own neighbourhoods reproducible and valid? J Rehabil Med. 2011 Nov;43(11):1027-31. doi: 10.2340/16501977-0881. |
| 22871787 | Background | Southard V, Gallagher R. The 6MWT: will different methods of instruction and measurement affect performance of healthy aging and older adults? J Geriatr Phys Ther. 2013 Apr-Jun;36(2):68-73. doi: 10.1519/JPT.0b013e318264b5e8. |
| 21673494 | Background | Burr JF, Bredin SS, Faktor MD, Warburton DE. The 6-minute walk test as a predictor of objectively measured aerobic fitness in healthy working-aged adults. Phys Sportsmed. 2011 May;39(2):133-9. doi: 10.3810/psm.2011.05.1904. |
| 25084634 | Background | Ratter J, Radlinger L, Lucas C. Several submaximal exercise tests are reliable, valid and acceptable in people with chronic pain, fibromyalgia or chronic fatigue: a systematic review. J Physiother. 2014 Sep;60(3):144-50. doi: 10.1016/j.jphys.2014.06.011. Epub 2014 Jul 30. |
| 26971801 | Background | Leone M, Duverge S, Kalinova E, Bui HT, Comtois AS. Comparison of bioenergetics of walking during a multistage incremental shuttle walk test and a 6-min walk test in active older adults. Aging Clin Exp Res. 2017 Apr;29(2):239-246. doi: 10.1007/s40520-016-0555-0. Epub 2016 Mar 14. |
| Timed Up and Go test | View source |
| 6-Minute Walk test | View source |
| Incremental Shuttle Walk Test | View source |
| D009422 |
| Nervous System Diseases |