Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia

ISRCTN ISRCTN68584893
DOI https://doi.org/10.1186/ISRCTN68584893
Secondary identifying numbers N/A
Submission date
28/11/2013
Registration date
09/12/2013
Last edited
24/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Mª Ángeles Pastor Mira
Scientific

Departamento de Psicología de la Salud
Campus de San Juan
Universidad Miguel Hernández
Ctra. Alicante-Valencia, Km. 8,7
San Juan (Alicante)
03550
Spain

Phone +34 965919473
Email mapastor@umh.es

Study information

Study designMulticentre experimental randomized triple-blinded study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCombining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: a randomised controlled trial
Study objectivesFibromyalgia 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(s)The Research Ethics Board of the Miguel Hernández University, 21/01/2011, ID: DPS-MPM-001-11
Health condition(s) or problem(s) studiedFibromyalgia
InterventionThe 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 typeOther
Primary outcome measureTwo 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 measures1. 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 study start date01/09/2012
Completion date01/09/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexFemale
Target number of participants582
Key inclusion criteria1. 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
Key exclusion criteriaComorbidity which impedes walking
Date of first enrolment01/09/2012
Date of final enrolment01/09/2014

Locations

Countries of recruitment

  • Spain

Study participating centre

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

Sponsor information

Spanish Ministry of Science and Innovation (Spain)
Government

Subdirección General de Proyectos de Investigación
C/Ramírez de Arellano, 29
Madrid
28071
Spain

Phone +34 (0) 916037712
Email inmaculada.garcia@micinn.es

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/04/2014 Yes No