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Completed

NCT Number: NCT04655053

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de San Vicente del Raspeig

Alicante, 03690, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal intention

Behavioral

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 behavior

Behavioral

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)

Behavioral

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 outcomes

  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 outcomes

  1. Perceived exertion

    Time frame: Immediately after the experimental intervention

    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.

  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

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

Intervention for Self-regulation of Goals Related to Physical Exercise in People With Fibromyalgia: Motivational and Volitional Components

Acronym: IAMEFI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2020
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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