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

Fibromyalgia Clinical Trial

— IAMEFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655053
• Other study ID #: PSI2016-79566-C2-1-R
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2022
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: June 30, 2021
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de San Vicente del Raspeig	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of walking	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)	Immediately after the experimental intervention
Secondary	Perceived exertion	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.	Immediately after the experimental intervention
Secondary	Physical activity intensity	Percentage of participants with moderate physical activity according to the accelerometer.	Immediately after the experimental intervention
Secondary	Walking speed	Speed mean in each experimental group	Immediately after the experimental intervention