Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia (IAMEFI)

Miguel Hernández University of Elche

Status: Completed

Conditions: Fibromyalgia

Treatments: Behavioral: Implementation intention to initiate the behavior; Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not); Behavioral: Goal intention

Study type: Interventional

Funder types: Other

Identifiers

NCT04655053

PSI2016-79566-C2-1-R

Details and patient eligibility

About

This work is part of a broader research with women with fibromyalgia. The aim of this study is to establish the effectiveness of implementation intentions to manage the preference for avoiding pain and fatigue and stop walking exercise, versus to maintain the approximate behavior (walking), taking into account high and low pain catastrophizing conditions.

Full description

Fibromyalgia is a widespread and diffuse musculoskeletal chronic pain problem not associated with inflammatory or degenerative changes, often accompanied by fatigue and sleep problems, in addition to anxiety, depression and cognitive dysfunction. Its prevalence in Europe for adults is estimated at 2.5% with a higher proportion of women. The treatment incorporates physical activity and exercise as one of its therapeutic aims has shown positive effects on health outcomes.However, it has been reported that women with fibromyalgia are less active than others with similar socio-demographic characteristics.Theories of behavioral self-regulation that taking into account motivational and volitional processes (implementation intentions) provide a conceptual framework to work with the incorporation and maintenance of the exercise, helping these people to create strong goals and handle the different self-regulation problems that can arise. These include the ones related to the preference for avoidance goals (pain or fatigue avoidance) against performing or keep doing an activity (walking exercise). This work searches to help women with fibromyalgia to manage the above mentioned inhibitors to incorporate and maintain long-term physical exercise walking. We consider the heterogeneity of people with fibromyalgia in pain catastrophizing, which makes necessary to adapt interventions aimed to promote physical exercise.

We expect participants with high catastrophizing and implementation intentions to control the preference for avoiding pain or fatigue will walk more time than the other conditions.

Enrollment: 252 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with fibromyalgia attended the Fibromyalgia Unit of the Valencian Community (Hospital of San Vicente del Raspeig, Alicante)
• Within the age limits

Exclusion criteria

• Comorbidity that prevents walking
• Those related to the 6MWT application protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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252 participants in 3 patient groups

Goal intention condition

Active Comparator group

Description:

Participants in this condition are asked to form the goal condition: "I will walk as fast as I can for as long as I can"

Treatment:

Behavioral: Goal intention

Implementation intention (behavior initiation) condition

Experimental group

Description:

Participants in this condition are asked to form the same goal intention ( "I will walk as fast as I can for as long as I can") and add the if-then plan ("and if I do the task, then I will walk as much as I can!")

Treatment:

Behavioral: Implementation intention to initiate the behavior

Implementation intention (goal preference management) condition

Experimental group

Description:

Participants in this condition are asked to form the same goal intention ( "I will walk as fast as I can for as long as I can") and add the if-then plan ("and if at this moment I prefer not to walk because of my pain (or fatigue; depending on person), then I will accept that I have this difficulty and I will walk as much as I can!)

Treatment:

Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not)