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Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Prehabilitation for behavioural change
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Lifestyle, Education, Self-management, Physical Activity, Proof-of-concept study

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The VINE center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prehabilitation group

Arm Description

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.

Outcomes

Primary Outcome Measures

Acceptability and credibility of the prehabilitation intervention
The treatment acceptability and credibility questionnaire
Number of sessions attended
Percentage of participants attending to more than 80% of the education sessions
Number of drop outs and reasons for early withdrawal
Percentage of participants that do complete the study
Number of questionnaires completed and returned
Percentage of participants that complete and return, at least, 80% of the questionnaires

Secondary Outcome Measures

Severity of fibromyalgia (also know as, impact of fibromyalgia)
the Revised FM Impact Questionnaire
Pain intensity
0-10 NRS
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.
Fatigue
the Multidimensional Fatigue Inventory
health related quality of life
the Short-Form Health Survey
physical activity
the International Physical Activity Questionnaire
Sedentary Behaviour
Sedentary Behaviour Questionnaire
exercise self-efficacy
the Exercise Self Efficacy Questionnaire
sleep quality
the Pittsburgh Sleep Quality Index questionnaire

Full Information

First Posted
November 27, 2018
Last Updated
December 3, 2018
Sponsor
Universidad de Granada
Collaborators
University of Ulster
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1. Study Identification

Unique Protocol Identification Number
NCT03764397
Brief Title
Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia
Official Title
Development and Piloting of a Prehabilitation Behavioural Change and Physical Activity Intervention for Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
November 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
University of Ulster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Lifestyle, Education, Self-management, Physical Activity, Proof-of-concept study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation for behavioural change
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability and credibility of the prehabilitation intervention
Description
The treatment acceptability and credibility questionnaire
Time Frame
Time point(s): once, right after the education programme. Time frame: An average of the past 4 weeks
Title
Number of sessions attended
Description
Percentage of participants attending to more than 80% of the education sessions
Time Frame
Time point(s): once, right after the education programme. Time frame: The past 4 weeks
Title
Number of drop outs and reasons for early withdrawal
Description
Percentage of participants that do complete the study
Time Frame
Time point(s): once, right after the education programme. Time frame: The 4 past weeks
Title
Number of questionnaires completed and returned
Description
Percentage of participants that complete and return, at least, 80% of the questionnaires
Time Frame
Time point(s): once, right after the education programme. Time frame: The 4 past weeks
Secondary Outcome Measure Information:
Title
Severity of fibromyalgia (also know as, impact of fibromyalgia)
Description
the Revised FM Impact Questionnaire
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Title
Pain intensity
Description
0-10 NRS
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Title
Pain catastrophizing
Description
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 Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Title
Fatigue
Description
the Multidimensional Fatigue Inventory
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: The past week
Title
health related quality of life
Description
the Short-Form Health Survey
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Title
physical activity
Description
the International Physical Activity Questionnaire
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past 7 days
Title
Sedentary Behaviour
Description
Sedentary Behaviour Questionnaire
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: the past week
Title
exercise self-efficacy
Description
the Exercise Self Efficacy Questionnaire
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.
Title
sleep quality
Description
the Pittsburgh Sleep Quality Index questionnaire
Time Frame
Time point(s): 3 (baseline, 4th and 10th weeks). Time frame: "in general", an average of the past 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ciara Hughes, PhD
Organizational Affiliation
Ulster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The VINE center
City
Belfast
ZIP/Postal Code
BT14 7DX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
To be decided

Learn more about this trial

Prehabilitation for Being Active. A Feasibility Study in Fibromyalgia

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