FibromyalgiaNCT03764397
Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia
A study testing Prehabilitation for behavioural change in people with Fibromyalgia, run by Universidad de Granada at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Prehabilitation for behavioural change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2018to 26 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Development and Piloting of a Prehabilitation Behavioural Change and Physical Activity Intervention for Fibromyalgia Syndrome
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.
Read more
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
- Being tested
- Prehabilitation for behavioural change
- Keywords
- Lifestyle, Education, Self-management, Physical Activity, Proof-of-concept study
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation for behavioural changeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prehabilitation for behavioural change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and credibility of the prehabilitation intervention
The treatment acceptability and credibility questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
the Revised FM Impact Questionnaire
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Pain intensity
0-10 NRS
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
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.
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Fatigue
the Multidimensional Fatigue Inventory
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
health related quality of life
the Short-Form Health Survey
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
physical activity
the International Physical Activity Questionnaire
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days
Sedentary Behaviour
Sedentary Behaviour Questionnaire
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week
exercise self-efficacy
the Exercise Self Efficacy Questionnaire
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
sleep quality
the Pittsburgh Sleep Quality Index questionnaire
Measured: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start26 Nov 2018
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Principal investigator, Fernando Estévez-López, Universidad de Granada
- Investigators
- Ciara Hughes, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764397
- Sponsor's protocol ID
- 18/0079
- Status last verified
- Dec 2018
- First submitted
- 27 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Publications
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.
PubMed 37451740
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Piloting of a Prehabilitation Behavioural Change and Physical Activity Intervention for Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT03764397
- Acronym / sponsor ID
- 18/0079
- Conditions
- Fibromyalgia
- Keywords
- Lifestyle, Education, Self-management, Physical Activity, Proof-of-concept study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University of Ulster
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: Prehabilitation for behavioural changeA 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation for behavioural changeThe 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. | Behavioural | Prehabilitation group |
Primary outcome
Acceptability and credibility of the prehabilitation intervention
Time frame: Time point(s): once, right after the education programme. Time frame: An average of the past 4 weeks
The treatment acceptability and credibility questionnaire
Number of sessions attended
Time frame: Time point(s): once, right after the education programme. Time frame: The past 4 weeks
Percentage of participants attending to more than 80% of the education sessions
Number of drop outs and reasons for early withdrawal
Time frame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
Percentage of participants that do complete the study
Number of questionnaires completed and returned
Time frame: Time point(s): once, right after the education programme. Time frame: The 4 past weeks
Percentage of participants that complete and return, at least, 80% of the questionnaires
9 secondary outcomes
Severity of fibromyalgia (also know as, impact of fibromyalgia)
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Pain intensity
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Pain catastrophizing
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Fatigue
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
health related quality of life
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
physical activity
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days
Sedentary Behaviour
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week
exercise self-efficacy
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
sleep quality
Time frame: Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Derived from this study: PubMed 37451740Courel-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.
- Individual participant dataSharing planned: Undecided. To be decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciara Hughes, PhD principal investigator
Ulster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation for behavioural change in people with Fibromyalgia, run by Universidad de Granada at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and credibility of the prehabilitation intervention (time frame: Time point(s): once, right after the education programme. Time frame: An average of the past 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.