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

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655053


Contacts
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Contact: María-Ángeles Pastor-Mira, PhD 34 965919470 mapastor@umh.es
Contact: Sofía López-Roig, PhD 34 965919463 slroig@umh.es

Locations
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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
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Principal Investigator: María-Ángeles Pastor-Mira, PhD Universidad Miguel Hernández
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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    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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