Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia

NCT03764397 | Completed DMC

• 1 other identifier: 18/0079
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Lifestyle; Education; Self-management; Physical Activity; Proof-of-concept study

Outcome Measures

Primary Outcomes (4)

• Acceptability and credibility of the prehabilitation intervention

  The treatment acceptability and credibility questionnaire

  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 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 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 point(s): once, right after the education programme. Time frame: The 4 past weeks

Secondary Outcomes (9)

• Severity of fibromyalgia (also know as, impact of fibromyalgia)

  Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week

• Pain intensity

  Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week

• Pain catastrophizing

  Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.

• Fatigue

  Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week

• health related quality of life

  Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.

Study Arms (1)

Prehabilitation group

EXPERIMENTAL

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

Interventions

Prehabilitation for behavioural change 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.

Prehabilitation group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• University of Ulster: collaborator

Study Sites (1)

The VINE center

Belfast, BT14 7DX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37451740 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ciara Hughes, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 5, 2018
• Study Start: November 26, 2018
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

GB (1)