Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fibromyalgia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention 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)Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Only males
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...
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.
Tracking Information
- NCT #
- NCT04655053
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Investigators
- Principal Investigator: María-Ángeles Pastor-Mira, PhD Universidad Miguel Hernández