Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.

Fibromyalgia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06001034
• Other study ID #: 1441-23
• Secondary ID: 0560-N-22
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: August 2023
• Source: Universidad Pablo de Olavide
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Occlusive training in people with fibromyalgia

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 20, 2023
• Est. primary completion date: February 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Pablo de Olavide	Sevilla

Sponsors (4)

Lead Sponsor	Collaborator
José Carlos Rodríguez Bautista	Andaluz Health Service, Hospital Universitario de Valme, Universidad Pablo de Olavide

Country where clinical trial is conducted

Spain, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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.	Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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)
Primary	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)
Primary	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).
Primary	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)
Primary	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).
Primary	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.
Primary	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.
Primary	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.

External Links

•   30-second chair stand
•   6-Minute Walk test
•   Incremental Shuttle Walk Test
•   Timed Up and Go test