Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.

• ClinicalTrials.gov Identifier: NCT06001034
• Recruitment Status: Completed
• First Posted: August 21, 2023
• Last Update Posted: August 21, 2023
• Sponsor: José Carlos Rodríguez Bautista
• Collaborators: Universidad Pablo de Olavide; Hospital Universitario de Valme; Andaluz Health Service
• Information provided by (Responsible Party): José Carlos Rodríguez Bautista, Universidad Pablo de Olavide

Study Description

Brief Summary:

Occlusive training in people with fibromyalgia

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Device: Occlusion training	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A 9-week Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia in a Hospital Setting, and Its Impact on Blood/Plasma Variables, Quality of Life and Functional Autonomy.
• Actual Study Start Date: September 15, 2022
• Actual Primary Completion Date: February 5, 2023
• Actual Study Completion Date: May 20, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1: Aerobic exercise plus occlusive tool.; Performing low-impact aerobic exercise with an occlusive tool 2 days per week.	Device: Occlusion training; Impact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia.; Other Name: Occlusive cuffing during aerobic exercise in participants with fibromyalgia
No Intervention: Group 2: Aerobic exercise without occlusive tool.; Performing low-impact aerobic exercise without an occlusive tool 2 days per week.

Outcome Measures

Primary Outcome Measures :

1. Change in Coenzyme Q10 after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
   Coenzyme Q10
2. Change in total antioxidants after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
   TAS
3. Change in disease impact questionnaire WPI after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
   WPI; score between (0-19). The higher the score, the greater the impact of the disease.
4. Change in disease impact questionnaire SSscore after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 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.
5. Change in disease impact questionnaire FIQ after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
   FIQ; score between (0-100). The higher the score, the greater the impact of the disease
6. Change in disease impact questionnaire MFI-20 after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 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.
7. Change in high density lipoproteins after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
   HDL
8. Change in low density lipoproteins after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
   LDL
9. Change in total cholesterol lipoproteins after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
   CHOL
10. Change in triglycerides after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    TG
11. Changes in urea after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    Urea
12. Changes in creatinine after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    Creatinine
13. Change in gamma-glutamyl transferase after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    GGT
14. Change in glutamic-pyruvic transaminase after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    GPT
15. Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    GOT
16. Change in alkaline phosphatase after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    ALP
17. Change in funcional test after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period) ]
    6-minute walking test
18. Change in funcional test after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period) ]
    incremental shuttle walking test
19. Change in funcional test after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    30 second chair and stand test
20. Change in funcional test after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period) ]
    Time and go test
21. Change in malondialdehyde after a 9-week intervention period. [ Time Frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period). ]
    MDA (malondialdehyde)
22. Change in distance traveled after a 9-week intervention period. [ Time Frame: From week 1 to week 9 of the 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.
23. Change in visual pain scale VAS over a 9-week intervention period. [ Time Frame: From week 1 to week 9 of the 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.
24. Change in perceived exertion scale BORG over a 9-week intervention period. [ Time Frame: From week 1 to week 9 of the 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

A patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (American Rheumatology Association). Wolfe et al., (2010).

• o 1) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Score (SS Score) ≥ 5 or WPI 3-6 and SS ≥ 9.
• Symptoms have been present, at a similar level, during the last three months.
• The patient has no other pathology that could explain the pain.
• Recent negative COVID-19 test.

Exclusion Criteria:

• Other associated pathologies that may hinder the development of the research.
• Mobility limitations.
• Injuries that add to those of the disease itself and hinder mobility.
• No medical evaluation of the diagnosis of the disease.
• Negative results in the inclusion tests.
• Cardiac pathologies.
• Blood pressure higher than 130-90 mmHg.
• No COVID-19 test.

Contacts and Locations

Locations

Spain

Universidad Pablo de Olavide

Sevilla, Spain, 41013

Sponsors and Collaborators

José Carlos Rodríguez Bautista

Universidad Pablo de Olavide

Hospital Universitario de Valme

Andaluz Health Service

Investigators

• Principal Investigator: José Carlos Rodríguez Bautista, PhD currently; Universidad Pablo de Olavide

  Study Documents (Full-Text)

Documents provided by José Carlos Rodríguez Bautista, Universidad Pablo de Olavide:

Study Protocol and Statistical Analysis Plan  [PDF] June 6, 2023

More Information

Additional Information:

30-second chair stand 

Timed Up and Go test 

6-Minute Walk test 

Incremental Shuttle Walk Test 

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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, Avon). 2016 Mar;33:1-6. doi: 10.1016/j.clinbiomech.2016.01.009. Epub 2016 Feb 2.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: José Carlos Rodríguez Bautista, PhD currently Sport Sciences in Physical Activity, Health and Quality of Life, Universidad Pablo de Olavide
• ClinicalTrials.gov Identifier: NCT06001034
• Other Study ID Numbers: 1441-23; 0560-N-22 ( Other Identifier: PEIBA. Junta de Andalucía. Government of Spain. )
• First Posted: August 21, 2023
• Last Update Posted: August 21, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Numeric code to each participant, concealing their personal data at all times.
• Supporting Materials: Study Protocol; Analytic Code
• Time Frame: The protocol before the start and the numerical codes at the end of the intervention period.
• Access Criteria: Shared use only from principal investigator with collaborating investigators of the study.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by José Carlos Rodríguez Bautista, Universidad Pablo de Olavide:

occlusive training

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases