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

Sponsor

Universidad Miguel Hernandez de Elche (Other)

Overall Status

Completed

CT.gov ID

NCT04655053

Collaborator

Ministerio de Economía y Competitividad, Spain (Other)

252

Enrollment

Location

Arms

7.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Behavioral: Goal intention Behavioral: Implementation intention to initiate the behavior Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

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)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

Official Title:

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

Actual Study Start Date :

Nov 2, 2020

Actual Primary Completion Date :

Apr 29, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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"	Behavioral: Goal intention Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.
Experimental: 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!")	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.
Experimental: 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!)	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.

Arm

Intervention/Treatment

Active Comparator: 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"

Behavioral: Goal intention

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

Experimental: 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!")

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.

Experimental: 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!)

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.

Outcome Measures

Primary Outcome Measures

Time of walking [Immediately after the experimental intervention]
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)

Secondary Outcome Measures

Perceived exertion [Immediately after the experimental intervention]
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.
Physical activity intensity [Immediately after the experimental intervention]
Percentage of participants with moderate physical activity according to the accelerometer.
Walking speed [Immediately after the experimental intervention]
Speed mean in each experimental group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with fibromyalgia attended the Fibromyalgia Unit of the Valencian Community (Hospital of San Vicente del Raspeig, Alicante)
Within the age limits