Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia

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%).

Conditions

• Fibromyalgia

Interventions

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.

Sponsors & Collaborators

• University of Ulster

  collaborator OTHER

• Universidad de Granada

  lead OTHER

Principal Investigators

• Ciara Hughes, PhD · Ulster University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-26

Primary Completion

2018-11-26

Completion

2018-11-26

Countries

• United Kingdom

Study Locations