Clinical trial NCT03764397: Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia
Official title: Development and Piloting of a Prehabilitation Behavioural Change and Physical Activity Intervention for Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Lifestyle
Education
Self-management
Physical Activity
Proof-of-concept study
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University of Ulster
First posted: 2018-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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%).


Eligibility criteria: Inclusion Criteria:

* Participants must have been diagnosed with FM by a medical practitioner, which will be confirmed by the research team -i.e., the modified 2011 preliminary FM criteria questionnaire (Appendix 14) by satisfying 'widespread pain index' (WPI) and 'symptom severity scale' (SS) as follows, either WPI ≥7 and the SS ≥5, or the WPI is 3-6 and the SS ≥9.

Exclusion Criteria:

* Younger than 16 years old.
* Not able to communicate in English.
* Mobilise dependently/aided.
* Have any medical condition that would make exercise participation unsafe (for example; heart disease, stroke, respiratory disease, severe mobility problems, severe arthritis or inflammatory joint disease).
* Are involved in ongoing litigation involving FM.
* Are currently under active treatment by a physiotherapist or involved in any other research studies.
* Are pregnant.

Primary outcomes:
measure: Acceptability and credibility of the prehabilitation intervention
timeFrame: Time point(s): once, right after the education programme. Time frame: An average of the past 4 weeks
measure: Number of sessions attended
timeFrame: Time point(s): once, right after the education programme. Time frame: The past 4 weeks
measure: Number of drop outs and reasons for early withdrawal
timeFrame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
measure: Number of questionnaires completed and returned
timeFrame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
Secondary outcomes:
measure: Severity of fibromyalgia (also know as, impact of fibromyalgia)
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
measure: Pain intensity
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
measure: Pain catastrophizing
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
measure: Fatigue
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
measure: health related quality of life
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
measure: physical activity
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days
measure: Sedentary Behaviour
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week
measure: exercise self-efficacy
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
measure: sleep quality
timeFrame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: The VINE center
Study officials:
affiliation: Ulster University
name: Ciara Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References: