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
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
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 |
|---|---|
| mapastor@umh.es |
Study information
| Study design | Multicentre experimental randomized triple-blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: a randomised controlled trial |
| Study objectives | 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(s) | The Research Ethics Board of the Miguel Hernández University, 21/01/2011, ID: DPS-MPM-001-11 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2012 |
| Completion date | 01/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 582 |
| Key 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 |
| Key exclusion criteria | Comorbidity which impedes walking |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 01/09/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
03550
Spain
Sponsor information
Government
Subdirección General de Proyectos de Investigación
C/Ramírez de Arellano, 29
Madrid
28071
Spain
| Phone | +34 (0) 916037712 |
|---|---|
| inmaculada.garcia@micinn.es |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
