Condition category
Musculoskeletal Diseases
Date applied
28/11/2013
Date assigned
09/12/2013
Last edited
24/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fibromyalgia is a condition that involves widespread and diffuse chronic pain. For such patients, moderate aerobic exercises have shown positive health outcomes. Adherence to physical activity in the medium and long term is an important problem. This study addresses an important need: to increase adherence to a unsupervised walking program. Behavioral theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: theory of planned behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) work better than a single intervention. This study aims to identify the motivational processes involved in adherence to walking and to test how well a intervention that combines motivational and volitional elements will work.

Who can participate?
Patients diagnosed of Fibromyalgia attending patients associations in Alicante, Elche, Madrid and Talavera de la Reina in Spain.

What does the study involve?
Participants will be randomly allocated to one of three groups: motivational and volitional, volitional only, posture advice. The three groups will receive the same information on the benefits of physical exercise and walking. The motivational intervention enhances self-efficacy and personal positive consequences of walking. The volitional intervention includes the formulation of goals and of ‘if… then…’ plans to carry out the personal goals related to the walking program.
Over a period of three years participants will come five times to the University for measures and intervention. When the intervention starts, patients will fill a daily logs and use a pedometer.

What are the possible benefits and risks of participating?
There will be no any risk and immediate direct benefit to those taking part. But there should be benefits in the future because results are expected to show that the intervention under consideration works well and this can be incorporated into routine clinical practice in the future.

Where is the study run from?
The study has been set up by the Universities of Miguel Hernandez (Elche) and Rey Juan Carlos (Madrid) in collaboration with Fibromyalgia patients associations from Alicante, Elche, Madrid and Talavera de la Reina (Spain).

When is the study starting and how long is it expected to run for?
Recruitment started mid-2012 and it will be finished at the end of 2014. Participants will be enrolled on the study for a period of three years.

Who is funding the study?
Funding has been provided by a competitive grant from the Spanish Ministry of Economy and Competitiveness.

Who is the main contact?
Professor María-Ángeles Pastor Mira
mapastor@umh.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mª Ángeles Pastor Mira

ORCID ID

Contact details

Departamento de Psicología de la Salud
Campus de San Juan
Universidad Miguel Hernández
Ctra. Alicante-Valencia
Km. 8,7
San Juan (Alicante)
03550
Spain
+34 965919473
mapastor@umh.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: a randomised controlled trial

Acronym

Study hypothesis

Fibromyalgia is a complex chronic condition characterized by widespread musculoskeletal pain, fatigue, sleeping problems and other symptoms with no well-established etiology.

Our main hypothesis is that a combined intervention (both motivational and volitional) will significantly increase walking behavior in fibromyalgia patients. This effect will be higher than in a merely volitional intervention in the short term and will be stable in the medium and long term.

Ethics approval

The Research Ethics Board of the Miguel Hernández University, 21/01/2011, ID: DPS-MPM-001-11

Study design

Multicentre experimental randomized triple-blinded study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fibromyalgia

Intervention

The intervention is based on two well-established theories for predicting behavior. One group will receive a motivational plus implementation intention intervention, a second group will receive only an implementation intention intervention and the control group will be given a neutral task related to postural hygiene. The three groups will receive the same information on the benefits of physical exercise in fibromyalgia. The motivational intervention will be based on the predictors of behavioral intention, in order to create or strengthen the behavioral intention during the experimental study. Implementation intentions are 'if-then' plans that specify when, where and how a goal will be achieved, linking a critical situation ('if' component) with a goal-directed behavior ('then' component).

Longitudinal measures: baseline, 7 weeks, 3 and 9 months post experimental intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Two primary outcomes will be assessed as an indicator of the intervention effect on exercise adherence:

1. Proportion of participants who perform the full minimum walking criteria at the end of the period of 6 weeks, and the proportion of participants who maintain it at 3 and 9 months
2. Among participants who perform the full minimum walking criteria, we will focus on the proportion who reaches the recommended pattern for fibromyalgia patients at week 6

We will use self-reported measurements, self-reported items and daily logs, and a pedometer.

Secondary outcome measures

1. 6-minute Walk Test (6-MWT): the 6-MWT is a clinically relevant measure of the physical function that the Spanish Rheumatology Society recommends using with fibromyalgia patients
2. The short self-administered Spanish version of the International Physical Activity Questionnaire (s-IPAQ)
3. Fibromyalgia impact: Spanish adaptation of the Fibromyalgia Impact Questionnaire (FIQ)
4. Pain: total score of an 11-point numerical rating scale (NRS) (0 = 'no pain at all' and 10 = 'the worst pain you can imagine')
5. Emotional status: Spanish adaptation of the Hospital Anxiety and Depression Scale (HAD)

s-IPAQ , FIQ , NRS and HAD will be assessed in the first, second and third year

Overall trial start date

01/09/2012

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged between 18-70 years old
2. Fit London-4 criteria for fibromyalgia (London Fibromyalgia Epidemiology Study Screening Questionnaire: White et al., 1999; Branco et al., 2010)
3. Medical recommendation to walk

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

582

Participant exclusion criteria

Comorbidity which impedes walking

Recruitment start date

01/09/2012

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Departamento de Psicología de la Salud
San Juan (Alicante)
03550
Spain

Sponsor information

Organisation

Spanish Ministry of Science and Innovation (Spain)

Sponsor details

Subdirección General de Proyectos de Investigación
C/Ramírez de Arellano
29
Madrid
28071
Spain
+34 (0) 916037712
inmaculada.garcia@micinn.es

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Spanish Ministry of Economy and Competitiveness (Spain) (PSI 2011-25132)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24721143

Publication citations

  1. Protocol

    Pastor MÁ, López-Roig S, Lledó A, Peñacoba C, Velasco L, Schweiger-Gallo I, Cigarán M, Ecija C, Limón R, Sanz Y, Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial., Trials, 2014, 15, 120, doi: 10.1186/1745-6215-15-120.

Additional files

Editorial Notes