Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia

University of Granada (UGR)

Status: Completed

Conditions: Fibromyalgia

Treatments: Behavioral: Prehabilitation for behavioural change

Study type: Interventional

Funder types: Other

Identifiers

NCT03764397

18/0079

Details and patient eligibility

About

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%).

Enrollment: 12 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Prehabilitation group

Experimental group

Description:

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.

Treatment:

Behavioral: Prehabilitation for behavioural change