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

NCT04655053 | Completed

• 1 other identifier: PSI2016-79566-C2-1-R
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; walking exercise; implementation intentions; self-regulation; pain catastrophizing; women

Outcome Measures

Primary Outcomes (1)

• 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)

  Immediately after the experimental intervention

Secondary Outcomes (3)

• Perceived exertion

  Immediately after the experimental intervention

• Physical activity intensity

  Immediately after the experimental intervention

• Walking speed

  Immediately after the experimental intervention

Study Arms (3)

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"

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!")

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!)

Behavioral: Implementation intention to manage the goal preference (avoiding behavior or not)

Interventions

Goal intention BEHAVIORAL

Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.

Goal intention condition

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 (behavior initiation) condition

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.

Implementation intention (goal preference management) condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with fibromyalgia attended the Fibromyalgia Unit of the Valencian Community (Hospital of San Vicente del Raspeig, Alicante)
• Within the age limits

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Hospital de San Vicente del Raspeig

Alicante, 03690, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Self-Control

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Officials

• María-Ángeles Pastor-Mira, PhD

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor. Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: November 2, 2020
• Primary Completion: April 29, 2021
• Study Completion: June 30, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)