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

NCT ID: NCT04655053

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2021-06-30

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Goal intention condition

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"

Group Type: ACTIVE_COMPARATOR

Goal intention

Intervention Type: BEHAVIORAL

Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.

Implementation intention (behavior initiation) condition

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!")

Group Type: EXPERIMENTAL

Implementation intention to initiate the behavior

Intervention Type: BEHAVIORAL

Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.

Implementation intention (goal preference management) condition

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!)

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.

Interventions

Goal intention

Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.

Intervention Type: BEHAVIORAL

Implementation intention to initiate the behavior

Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.

Intervention Type: BEHAVIORAL

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

Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

María de los Ángeles Pastor Mira

Professor. Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

María-Ángeles Pastor-Mira, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Miguel Hernández

Locations

Hospital de San Vicente del Raspeig

Alicante, , Spain

Countries

Spain

Other Identifiers

PSI2016-79566-C2-1-R

Identifier Type: -

Identifier Source: org_study_id