Clinical trial NCT06001034: Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: occlusive training
Lead sponsor: Universidad Pablo de Olavide
Sponsor class: OTHER
Collaborators: name: Universidad Pablo de Olavide
name: Hospital Universitario de Valme
name: Andaluz Health Service
First posted: 2023-08-21
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Occlusive training in people with fibromyalgia

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.

Eligibility 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.

Primary outcomes:
measure: Change in Coenzyme Q10 after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in total antioxidants after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in disease impact questionnaire WPI after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in disease impact questionnaire SSscore after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in disease impact questionnaire FIQ after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in disease impact questionnaire MFI-20 after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in high density lipoproteins after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in low density lipoproteins after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in total cholesterol lipoproteins after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in triglycerides after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Changes in urea after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Changes in creatinine after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in gamma-glutamyl transferase after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in glutamic-pyruvic transaminase after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in alkaline phosphatase after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in funcional test after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
measure: Change in funcional test after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
measure: Change in funcional test after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in funcional test after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
measure: Change in malondialdehyde after a 9-week intervention period.
timeFrame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
measure: Change in distance traveled after a 9-week intervention period.
timeFrame: From week 1 to week 9 of the intervention period.
measure: Change in visual pain scale VAS over a 9-week intervention period.
timeFrame: From week 1 to week 9 of the intervention period.
measure: Change in perceived exertion scale BORG over a 9-week intervention period.
timeFrame: From week 1 to week 9 of the intervention period.
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad Pablo de Olavide
Study officials:
affiliation: Universidad Pablo de Olavide
name: José Carlos Rodríguez Bautista, PhD currently
role: PRINCIPAL_INVESTIGATOR
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