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

• ClinicalTrials.gov Identifier: NCT04655053
• Recruitment Status: Recruiting
• First Posted: December 4, 2020
• Last Update Posted: December 8, 2020
• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborator: Ministerio de Economía y Competitividad, Spain
• Information provided by (Responsible Party): María de los Ángeles Pastor Mira, Universidad Miguel Hernandez de Elche

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)	Not Applicable

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 (Clinical Trial)
• Estimated 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)

• 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: November 2, 2020
• Estimated Primary Completion Date: June 2021
• Estimated Study Completion Date: June 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.

Outcome Measures

Primary Outcome Measures :

1. Time of walking [ Time Frame: 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 :

1. Perceived exertion [ Time Frame: Immediately after the experimental intervention ]
   Score on the Borg Rating of Perceived Exertion Scale anchored at 10 (Borg CR10: 0=Not exertion at all; 10=Maximal). Higher scores mean higher perceived exertion.
2. Physical activity intensity [ Time Frame: Immediately after the experimental intervention ]
   Percentage of participants with moderate physical activity according to the accelerometer.
3. Walking speed [ Time Frame: Immediately after the experimental intervention ]
   Speed mean in each experimental group

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: María-Ángeles Pastor-Mira, PhD; 34 965919470; mapastor@umh.es

Contact: Sofía López-Roig, PhD; 34 965919463; slroig@umh.es

Locations

Spain

Hospital de San Vicente del Raspeig; Recruiting

Alicante, Spain, 03690

Contact: María-Ángeles Pastor-Mira, PhD 34 965919470 mapastor@umh.es

Contact: Sofía López-Roig, PhD 34 965919463 slroig@umh.es

Sponsors and Collaborators

Universidad Miguel Hernandez de Elche

Ministerio de Economía y Competitividad, Spain

Investigators

• Principal Investigator: María-Ángeles Pastor-Mira, PhD; Universidad Miguel Hernández

More Information

• Responsible Party: María de los Ángeles Pastor Mira, Professor. Principal Investigator, Universidad Miguel Hernandez de Elche
• ClinicalTrials.gov Identifier: NCT04655053
• Other Study ID Numbers: PSI2016-79566-C2-1-R
• First Posted: December 4, 2020
• Last Update Posted: December 8, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María de los Ángeles Pastor Mira, Universidad Miguel Hernandez de Elche:

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

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases