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

Intervention for Self-regulation of Goals Related to Physical Exercise in People With Fibromyalgia: Motivational and Volitional Components

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04655053
Acronym
IAMEFI
Enrollment
252
Registered
2020-12-04
Start date
2020-11-02
Completion date
2021-06-30
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

fibromyalgia, walking exercise, implementation intentions, self-regulation, pain catastrophizing, women

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.

Interventions

BEHAVIORALGoal intention

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

BEHAVIORALImplementation 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.

BEHAVIORALImplementation 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.

Sponsors

Ministerio de Economía y Competitividad, Spain
CollaboratorOTHER_GOV
Universidad Miguel Hernandez de Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time of walkingImmediately after the experimental interventionThe 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

MeasureTime frameDescription
Perceived exertionImmediately after the experimental interventionScore 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 intensityImmediately after the experimental interventionPercentage of participants with moderate physical activity according to the accelerometer.
Walking speedImmediately after the experimental interventionSpeed mean in each experimental group

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026