Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia

NCT ID: NCT03764397

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2018-11-26

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%).

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prehabilitation group

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.

Group Type: EXPERIMENTAL

Prehabilitation for behavioural change

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulster

OTHER

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Fernando Estévez-López

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ciara Hughes, PhD

Role: PRINCIPAL_INVESTIGATOR

Ulster University

Locations

The VINE center

Belfast, , United Kingdom

Countries

United Kingdom

References

Courel-Ibanez J, Estevez-Lopez F, Hughes C, Adams N, Fullen BM, Davison G, Montgomery A, Cramp F, Maestre C, Martin D, McVeigh JG. Proof of concept of prehabilitation: a combination of education and behavioural change, to promote physical activity in people with fibromyalgia. BMJ Open. 2023 Jul 14;13(7):e070609. doi: 10.1136/bmjopen-2022-070609.

Reference Type: DERIVED

PMID: 37451740 (View on PubMed)

Other Identifiers

18/0079

Identifier Type: -

Identifier Source: org_study_id