Fibromyalgia Clinical Trial
Official title:
Development and Piloting of a Prehabilitation Behavioural Change and Physical Activity Intervention for Fibromyalgia Syndrome
Twelve people with FM will be recruited from the FM patient support groups. The investigators
will develop and test a 4-week prehabilitation educational programme (i.e., a behavioural
change intervention) consisting of meeting once per week (each approximately 1 - 1.5 hours).
These dynamic and interactive meetings will focus on education and skills training in:
exercise, activity cycling, pacing, causes of symptoms in FM (pain, fatigue, sleep
dysfunction) and their management.
Participants will be taught to set specific, measurable, achievable, realistic and timed
goals (SMART principle) that are valuable or meaningful to them. To do so, the participants
will identify a 'committed action' plan. The principles of cognitive behavioural therapy will
be used to address maladaptive thoughts (e.g., catastrophizing and fear avoidance) and to
manage stress (e.g., skills of relaxation). Participants will learn how to use of pedometers
to monitor physical activity.
After the 4-week prehabilitation educational programme, the participants will be encouraged
to engage in a 6-week gentle self-paced walking programme (with weekly telephone support).
The 6-week walking programme will consist of a simple pedometer-driven intervention.
Furthermore, the research team will telephone each participant at a prearranged time each
week to discuss progress, to document mean daily step count and to discuss a new physical
activity target (step count) for the subsequent week. Participants will record daily step
counts (pedometer-derived) in a walking dairy which will be used as raw data and mean steps
per day calculated. Where a participant declines telephone support, an alternative weekly
email or text/WhatsApp messages will be offered instead, where the same information will be
given and requested.
Before (baseline measurements) and right after the completion of the 4-week prehabilitation
educational programme as well as the 6-week gentle self-paced walking programme the same
measurements will be taken. By doing so, the investigators will evaluate short and mid-term
changes promoted by the prehabilitation programme. The participants will fill out the
following questionnaires: the Revised FM Impact Questionnaire, Pain Catastrophizing Scale,
Multidimensional Fatigue Inventory, Short-Form 36-item Health Survey, International Physical
Activity Questionnaire, Sedentary Behaviour Questionnaire, Exercise Self Efficacy
Questionnaire, Pittsburgh Sleep Quality Index questionnaire, and the modified 2011
preliminary FM criteria questionnaire.
Right after the completion of the prehabiliation intervention, all the participants will fill
out the treatment acceptability and credibility questionnaire. Right after the completion of
the walking programme, participants will be interviewed (semistructured face-to-face exit
interview lasting about 30-45 minutes) to explore their experiences of the study including
barriers to participation.
The main outcome of the study will be acceptability and credibility of the prehabilitation
intervention (treatment acceptability and credibility questionnaire. Additionally, the
success of the prehabilitation programme will be based on (i) number of sessions attended
(>80%), (ii) number of drop outs (<15%) and reasons for early withdrawal, (iii) number of
screening questionnaires completed and returned (>80%).
n/a
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