Clinical trial NCT04655053: Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia
Official title: Intervention for Self-regulation of Goals Related to Physical Exercise in People With Fibromyalgia: Motivational and Volitional Components
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
walking exercise
implementation intentions
self-regulation
pain catastrophizing
women
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2020-12-04
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Self-regulation condition (between-factor): Goal intention condition (IC), implementation intention condition focused on behavior initiation (IIC-Behavior), implementation intention condition focused on goal preference management (IIC-Motivational).

Pain catastrophizing (within factor): Low (equal or less 31 score on this variable) and high (more than 31 score in this variable)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time of walking
timeFrame: Immediately after the experimental intervention
Secondary outcomes:
measure: Perceived exertion
timeFrame: Immediately after the experimental intervention
measure: Physical activity intensity
timeFrame: Immediately after the experimental intervention
measure: Walking speed
timeFrame: Immediately after the experimental intervention
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital de San Vicente del Raspeig
Study officials:
affiliation: Universidad Miguel Hernández
name: María-Ángeles Pastor-Mira, PhD
role: PRINCIPAL_INVESTIGATOR
References: