Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.

José Carlos Rodríguez Bautista

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Occlusion training

Study type: Interventional

Funder types: Other

Identifiers

NCT06001034

0560-N-22 (Other Identifier)

1441-23

Details and patient eligibility

About

Occlusive training in people with fibromyalgia

Full 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.

Enrollment: 37 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Group 1: Aerobic exercise plus occlusive tool.

Experimental group

Description:

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

Treatment:

Device: Occlusion training

Group 2: Aerobic exercise without occlusive tool.

No Intervention group

Description:

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