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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not); Behavioral: Implementation intention to initiate the behavior; Behavioral: Goal intention

• Registration Number: NCT04655053
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-11-02
• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-04
• Primary Completion: 2021-04-29
• Study Completion: 2021-06-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Implementation intention (goal preference management) condition	Implementation intention to manage the goal preference (avoiding behavior or not)	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!)
Implementation intention (behavior initiation) condition	Implementation intention to initiate the behavior	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!")
Goal intention condition	Goal intention	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"

Primary Outcome Measures

Name	Time	Method
Time of walking	Immediately after the experimental intervention	The six-minutes walk test (6MWT) test is adapted to simulate a behavioural maintenance scenario of the walking exercise. Thus, the measure is the time of walking (maximum of 30m)

Secondary Outcome Measures

Name	Time	Method
Perceived exertion	Immediately after the experimental intervention	Score on the Borg Rating of Perceived Exertion Scale anchored at 10 (Borg: 0=Not exertion at all; 10=Maximal). Higher scores mean higher perceived exertion.
Physical activity intensity	Immediately after the experimental intervention	Percentage of participants with moderate physical activity according to the accelerometer.
Walking speed	Immediately after the experimental intervention	Speed mean in each experimental group

Trial Locations

Locations (1)

Hospital de San Vicente del Raspeig; 🇪🇸 Alicante, Spain