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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Change in Coenzyme Q10 after a 9-week intervention period.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 ≥
- •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.
Outcomes
Primary Outcomes
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
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.
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
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
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.
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
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.
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.
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
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
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
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
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
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)
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
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
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
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
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.
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.
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
Secondary Outcomes
No secondary outcomes reported
Investigators
José Carlos Rodríguez Bautista
PhD currently Sport Sciences in Physical Activity, Health and Quality of Life
Universidad Pablo de Olavide