FibromyalgiaIAMEFINCT04655053
Intervention for Self-regulation to Physical Exercise in People With Fibromyalgia
A study testing Goal intention, Implementation intention to initiate the behavior and Implementation intention to manage the goal preference (avoiding behavior or not) in people with Fibromyalgia, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Goal intention, Implementation intention to initiate the behavior and Implementation intention to manage the goal preference (avoiding behavior or not)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with fibromyalgia attended the Fibromyalgia Unit of the Valencian Community (Hospital of San Vicente del Raspeig, Alicante)
- Within the age limits
Who cannot join
- Comorbidity that prevents walking
- Those related to the 6MWT application protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention for Self-regulation of Goals Related to Physical Exercise in People With Fibromyalgia: Motivational and Volitional Components
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Goal intention, Implementation intention to initiate the behavior, Implementation intention to manage the goal preference (avoiding behavior or not)
- Keywords
- fibromyalgia, walking exercise, implementation intentions, self-regulation, pain catastrophizing, women
- Medical subject headings
- Fibromyalgia, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal intentionBehavioural
Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.
Implementation intention to initiate the behaviorBehavioural
Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.
Implementation intention to manage the goal preference (avoiding behavior or not)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Goal intention condition | Active comparator | 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" Receives: Behavioral: Goal intention |
| Implementation intention (behavior initiation) condition | Experimental | 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!") Receives: Behavioral: Implementation intention to initiate the behavior |
| Implementation intention (goal preference management) condition | Experimental | 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!) Receives: Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately after the experimental intervention
Secondary outcomes (3)
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.
Measured: Immediately after the experimental intervention
Physical activity intensity
Percentage of participants with moderate physical activity according to the accelerometer.
Measured: Immediately after the experimental intervention
Walking speed
Speed mean in each experimental group
Measured: Immediately after the experimental intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start2 Nov 2020
- Primary completion29 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, María de los Ángeles Pastor Mira, Universidad Miguel Hernandez de Elche
- Investigators
- María-Ángeles Pastor-Mira, PhD, Principal investigator, Universidad Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655053
- Sponsor's protocol ID
- PSI2016-79566-C2-1-R
- Acronym
- IAMEFI
- Status last verified
- May 2022
- First submitted
- 27 Nov 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Self-regulation of Goals Related to Physical Exercise in People With Fibromyalgia: Motivational and Volitional Components
- ClinicalTrials.gov ID
- NCT04655053
- Acronym / sponsor ID
- IAMEFI / PSI2016-79566-C2-1-R
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, walking exercise, implementation intentions, self-regulation, pain catastrophizing, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Goal intention condition | Active comparator | Behavioral: Goal intentionParticipants in this condition are asked to form the goal condition: "I will walk as fast as I can for as long as I can" |
| Implementation intention (behavior initiation) condition | Experimental | Behavioral: Implementation intention to initiate the behaviorParticipants 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!") |
| Implementation intention (goal preference management) condition | Experimental | Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not)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!) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with fibromyalgia attended the Fibromyalgia Unit of the Valencian Community (Hospital of San Vicente del Raspeig, Alicante)
- Within the age limits
Key exclusion criteria (2 listed)
- Comorbidity that prevents walking
- Those related to the 6MWT application protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal intentionResearcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once. | Behavioural | Goal intention condition |
| Implementation intention to initiate the behaviorResearcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once. | Behavioural | Implementation intention (behavior initiation) condition |
| 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. | Behavioural | Implementation intention (goal preference management) condition |
Primary outcome
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)
3 secondary outcomes
Perceived exertion
Time frame: Immediately after the experimental intervention
Physical activity intensity
Time frame: Immediately after the experimental intervention
Walking speed
Time frame: Immediately after the experimental intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María-Ángeles Pastor-Mira, PhD principal investigator
Universidad Miguel Hernández
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal intention, Implementation intention to initiate the behavior and Implementation intention to manage the goal preference (avoiding behavior or not) in people with Fibromyalgia, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of walking (time frame: Immediately after the experimental intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.