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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Goal intention
Implementation intention to initiate the behavior
Implementation intention to manage the goal preference (avoiding behavior or not)
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, walking exercise, implementation intentions, self-regulation, pain catastrophizing, women

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Exclusion Criteria:

  • Comorbidity that prevents walking
  • Those related to the 6MWT application protocol

Sites / Locations

  • Hospital de San Vicente del Raspeig

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Goal intention condition

Implementation intention (behavior initiation) condition

Implementation intention (goal preference management) condition

Arm Description

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"

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!")

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!)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
Physical activity intensity
Percentage of participants with moderate physical activity according to the accelerometer.
Walking speed
Speed mean in each experimental group

Full Information

First Posted
November 27, 2020
Last Updated
May 18, 2022
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04655053
Brief Title
Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia
Acronym
IAMEFI
Official Title
Intervention for Self-regulation of Goals Related to Physical Exercise in People With Fibromyalgia: Motivational and Volitional Components
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, walking exercise, implementation intentions, self-regulation, pain catastrophizing, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal intention condition
Arm Type
Active Comparator
Arm Description
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"
Arm Title
Implementation intention (behavior initiation) condition
Arm Type
Experimental
Arm Description
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!")
Arm Title
Implementation intention (goal preference management) condition
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Goal intention
Intervention Description
Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.
Intervention Type
Behavioral
Intervention Name(s)
Implementation intention to initiate the behavior
Intervention Description
Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.
Intervention Type
Behavioral
Intervention Name(s)
Implementation intention to manage the goal preference (avoiding behavior or not)
Intervention Description
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 Measure Information:
Title
Time of walking
Description
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)
Time Frame
Immediately after the experimental intervention
Secondary Outcome Measure Information:
Title
Perceived exertion
Description
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.
Time Frame
Immediately after the experimental intervention
Title
Physical activity intensity
Description
Percentage of participants with moderate physical activity according to the accelerometer.
Time Frame
Immediately after the experimental intervention
Title
Walking speed
Description
Speed mean in each experimental group
Time Frame
Immediately after the experimental intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María-Ángeles Pastor-Mira, PhD
Organizational Affiliation
Universidad Miguel Hernández
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de San Vicente del Raspeig
City
Alicante
ZIP/Postal Code
03690
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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