Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Development and Piloting of a Prehabilitation Behavioural Change and Physical Activity Intervention for Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764397
• Other study ID #: 18/0079
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: November 26, 2018

Study information

• Verified date: December 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The VINE center	Belfast

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Severity of fibromyalgia (also know as, impact of fibromyalgia)	the Revised FM Impact Questionnaire	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Secondary	Pain intensity	0-10 NRS	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Secondary	Pain catastrophizing	Pain catastrophizing is the tendency to describe a pain experience in more exaggerated terms than the average person, to ruminate on it more (e.g., "I kept thinking 'this is terrible'"), and/or to feel more helpless about the experience ("I thought it was never going to get better"). Pain catastrophizing will be measured by means of the Pain Catastrophizing Scale is a 13-item questionnaire in which patients are asked to reflect on past painful experiences and indicate their thoughts or feelings about pain, on a 5-point scale. For this study, the total score (range 0-52) was used, where higher scores represent a more negative appraisal of pain.	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Secondary	Fatigue	the Multidimensional Fatigue Inventory	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Secondary	health related quality of life	the Short-Form Health Survey	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Secondary	physical activity	the International Physical Activity Questionnaire	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days
Secondary	Sedentary Behaviour	Sedentary Behaviour Questionnaire	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week
Secondary	exercise self-efficacy	the Exercise Self Efficacy Questionnaire	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Secondary	sleep quality	the Pittsburgh Sleep Quality Index questionnaire	Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.