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Completed

NCT Number: NCT06001034

Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.

Occlusive training in people with fibromyalgia

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Pablo de Olavide

Seville, 41013, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Occlusive cuffing during aerobic exercise in participants with fibromyalgia

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

José Carlos Rodríguez Bautista

Other

Collaborators

  • Andaluz Health Service
  • Hospital Universitario de Valme
  • Universidad Pablo de Olavide

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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