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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

Tracking Information
First Submitted Date  ICMJE November 27, 2020
First Posted Date  ICMJE December 4, 2020
Last Update Posted Date December 8, 2020
Actual Study Start Date  ICMJE November 2, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • 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.
  • Physical activity intensity [ Time Frame: Immediately after the experimental intervention ]
    Percentage of participants with moderate physical activity according to the accelerometer.
  • Walking speed [ Time Frame: Immediately after the experimental intervention ]
    Speed mean in each experimental group
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • Perceived effort [ Time Frame: Immediately after the experimental intervention ]
    Score on the Börg' scale
  • Physical activity intensity [ Time Frame: Immediately after the experimental intervention ]
    Percentage of participants with moderate physical activity according to the accelerometer.
  • Walking speed [ Time Frame: Immediately after the experimental intervention ]
    Speed mean in each experimental group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia
Official Title  ICMJE Intervention for Self-regulation of Goals Related to Physical Exercise in People With Fibromyalgia: Motivational and Volitional Components
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Behavioral: Goal intention
    Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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"
    Intervention: Behavioral: Goal intention
  • 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!")
    Intervention: Behavioral: Implementation intention to initiate the behavior
  • 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!)
    Intervention: Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2020)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: María-Ángeles Pastor-Mira, PhD 34 965919470 mapastor@umh.es
Contact: Sofía López-Roig, PhD 34 965919463 slroig@umh.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04655053
Other Study ID Numbers  ICMJE PSI2016-79566-C2-1-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party María de los Ángeles Pastor Mira, Universidad Miguel Hernandez de Elche
Study Sponsor  ICMJE Universidad Miguel Hernandez de Elche
Collaborators  ICMJE Ministerio de Economía y Competitividad, Spain
Investigators  ICMJE
Principal Investigator: María-Ángeles Pastor-Mira, PhD Universidad Miguel Hernández
PRS Account Universidad Miguel Hernandez de Elche
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP