Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.

NCT06001034 | Completed DMC

• 2 other identifiers: 1441-230560-N-22
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Occlusive training in people with fibromyalgia

Conditions

Fibromyalgia

Keywords

occlusive training

Outcome Measures

Primary Outcomes (24)

• 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.

  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.

Study Arms (2)

Group 1: Aerobic exercise plus occlusive tool.

EXPERIMENTAL

Performing low-impact aerobic exercise with an occlusive tool 2 days per week.

Device: Occlusion training

Group 2: Aerobic exercise without occlusive tool.

NO INTERVENTION

Performing low-impact aerobic exercise without an occlusive tool 2 days per week.

Interventions

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.

Also known as: Occlusive cuffing during aerobic exercise in participants with fibromyalgia

Group 1: Aerobic exercise plus occlusive tool.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Cardiac pathologies.
• Blood pressure higher than 130-90 mmHg.
• No COVID-19 test.

Sponsors & Collaborators

• José Carlos Rodríguez Bautista: lead
• Universidad Pablo de Olavide: collaborator
• Hospital Universitario de Valme: collaborator
• Andaluz Health Service: collaborator

Study Sites (1)

Universidad Pablo de Olavide

Seville, 41013, Spain

Location

Related Publications (20)

• 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.

  PMID: 25617055 BACKGROUND

• 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.

  PMID: 26986947 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.

  PMID: 11842825 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.

  PMID: 26142171 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.

  PMID: 23116302 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.

  PMID: 24610539 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.

  PMID: 20417529 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.

  PMID: 14962957 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.

  PMID: 23600892 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.

  PMID: 19268526 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.

  PMID: 16809770 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.

  PMID: 27781288 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.

  PMID: 26878719 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.

  PMID: 14635298 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.

  PMID: 31899457 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.

  PMID: 22031349 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.

  PMID: 22871787 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.

  PMID: 21673494 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.

  PMID: 25084634 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.

  PMID: 26971801 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• José Carlos Rodríguez Bautista, PhD currently

  Universidad Pablo de Olavide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD currently Sport Sciences in Physical Activity, Health and Quality of Life

Model Details: Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 21, 2023
• Study Start: September 15, 2022
• Primary Completion: February 5, 2023
• Study Completion: May 20, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

ES (1)