An interventional study of Prehabilitation for behavioural change in Fibromyalgia, sponsored by Universidad de Granada. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment
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%).
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
A 4-week prehabilitation educational programme (i.e., a behavioral change intervention) and to pilot that prehabilitation in combination with a 6-week gentle self-paced walking programme (with weekly telephone support) in people with FM.
Behavioral: Prehabilitation for behavioural change
The 4-week prehabilitation educational programme will consist of a meeting for one session (approximately 1 - 1.5 hours) per week. This behavioural change programme will involve a mixture of interactive and didactic sessions, facilitated by a physiotherapist, psychologists, and other health professionals. The purpose of the initial prehabilitation programme is to gain participant 'buy-in' to the programme, to assist participants engage with exercise, to help participants overcome barriers to exercise and improve self-efficacy for exercise. The prehabilitation phase will also enable participants to understand why and how to perform gentle self-paced exercise. After the prehabilitation programme, participants will be advised to engage in a 6-week gentle self-paced walking programme; i.e., a simple pedometer-driven walking programme with weekly telephone support.
Acceptability and credibility of the prehabilitation intervention
The treatment acceptability and credibility questionnaire
Time frame: Time point(s): once, right after the education programme. Time frame: An average of the past 4 weeks
Number of sessions attended
Percentage of participants attending to more than 80% of the education sessions
Time frame: Time point(s): once, right after the education programme. Time frame: The past 4 weeks
Number of drop outs and reasons for early withdrawal
Percentage of participants that do complete the study
Time frame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
Number of questionnaires completed and returned
Percentage of participants that complete and return, at least, 80% of the questionnaires
Time frame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
Severity of fibromyalgia (also know as, impact of fibromyalgia)
the Revised FM Impact Questionnaire
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Pain intensity
0-10 NRS
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Pain catastrophizing
Pain catastrophizing is the tendency to describe a pain experience in more exaggerated terms than the average person, to ruminate on it more (e.g., "I kept thinking 'this is terrible'"), and/or to feel more helpless about the experience ("I thought it was never going to get better"). Pain catastrophizing will be measured by means of the Pain Catastrophizing Scale is a 13-item questionnaire in which patients are asked to reflect on past painful experiences and indicate their thoughts or feelings about pain, on a 5-point scale. For this study, the total score (range 0-52) was used, where higher scores represent a more negative appraisal of pain.
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Fatigue
the Multidimensional Fatigue Inventory
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
health related quality of life
the Short-Form Health Survey
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
physical activity
the International Physical Activity Questionnaire
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days
Sedentary Behaviour
Sedentary Behaviour Questionnaire
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week
exercise self-efficacy
the Exercise Self Efficacy Questionnaire
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
sleep quality
the Pittsburgh Sleep Quality Index questionnaire
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Plan to share: Undecided — To be decided
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Universidad de Granada