Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.

Study Overview
=================
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.

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.

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Device: Occlusion training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
occlusive training