FibromyalgiaNCT07777393
Fibromyalgia-Related Quality of Life and Exercise Motivation
An observational study of Fibromyalgia, run by University of Beira Interior at 1 site in Portugal.
Trial summary
The objective of this study is to evaluate possible correlations between motivation to engage in physical exercise and quality of life related to fibromyalgia, as well as the level of knowledge about fibromyalgia, and understand the factors that facilitate and the barriers to physical exercise. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fibromyalgia
- How many people
- 93 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2025to 20 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with fibromyalgia
Who may be able to join
- medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria
- at least 18 years old
- Portuguese nationality
Who cannot join
- medical condition that affects their ability to understand the text
- illiteracy
Trial locations and contacts
1 site in 1 country.
Portugal1 site
University of Beira Interior
Covilha, Castelo Branco District, 6230-001
About this study
Official title: Fibromyalgia-Related Quality of Life and Exercise Motivation: Exploring Barriers and Facilitators to Physical Activity
The objective of this study is to evaluate possible correlations between motivation to engage in physical exercise and quality of life related to fibromyalgia, as well as the level of knowledge about fibromyalgia, and understand the factors that facilitate and the barriers to physical exercise.
Read the detailed description
This is a cross-sectional study in which data will be collected via an online questionnaire from Portuguese citizens with fibromyalgia. Recruitment will take place nationwide, with the project being publicized through organizations and associations related to fibromyalgia. The following questionnaires will be administered: questions regarding knowledge of fibromyalgia, the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), the Tampa Kinesiophobia Scale, the Portuguese version of the Behavioral Regulation in Exercise Questionnaire (BREQ-4), and the Importance of Characteristics Associated with Exercise.
- Conditions
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Portuguese citizens with fibromyalgia | The form will be completed remotely and consists of 7 sections. These are: Acceptance of the Free, Informed, and Enlightened Consent Form (CLIE); Sociodemographic Information; Assessment of knowledge about the medical condition; The Fibromyalgia Impact Questionnaire Revised (FIQ-R) to assess the degree of impact of fibromyalgia; Tampa Kinesiophobia Scale to assess kinesiophobia; Motivation for physical exercise will be assessed using the Portuguese version of the Behavioral Regulation in Exercise Questionnaire (BREQ-4); and the importance of characteristics associated with exercise will be assessed using an adapted questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREQ-4
Motivation for physical exercise will be assessed using the Portuguese version of the Behavioral Regulation in Exercise Questionnaire (BREQ-4). The questionnaire consists of 21 items, with responses rated on a 5-point Likert scale, where 0: Not true for me; 2: Sometimes true for me; 5: Often true for me. The 21 items are divided into seven factors according to their respective items, which are: amotivation; external regulation ; introjected regulation by avoidance; introjected regulation by approach; identified regulation; integrated regulation and intrinsic motivation. Results will be obtained for each factor/regulation, and the final score that is, the relative autonomy index.
Measured: Day 1
Secondary outcomes (4)
Fibromyalgia Impact Questionnaire Revised
The questionnaire consists of 21 questions, all in an 11-point numerical scale format (0-10). This instrument assesses three domains: 9 items for function, 2 items for overall impact, and 10 items for symptoms. The domain scores are calculated by summing the respective items and dividing by 3 (function domain), 1 (impact domain), and 2 (symptoms domain), and range from 0-30, 0-20, and 0-50, respectively. The total score is calculated by summing the domain scores, resulting in a range of 0 to 100; the higher the score, the greater the impact of fibromyalgia.
Measured: Day 1
Fibromyalgia knowledge
This 20-question questionnaire was developed by researchers and contains statements to be answered as true or false, based on scientific studies; the statements were categorized into: general aspects of fibromyalgia; general treatments; physical exercise; and self-care. The more correct answers a person gives, the greater their knowledge of the condition.
Measured: Day 1
Tampa Scale for Kinesiophobia
Responses are provided using a 4-point Likert scale (1: strongly disagree; 2: disagree; 3: agree; 4: strongly agree). The results are obtained by summing the scores and range from 0 to 52; the higher the score, the greater the perceived fear.
Measured: Day 1
Barriers and characteristics associated to exercise
Twenty questions related to barriers, to which the volunteer must respond with "true" or "false" for each statement regarding the lack of physical activity in their daily life. 14 items to be rated on a 4-point Likert scale based on the degree of importance of characteristics associated with exercise (0: not important; 2: somewhat important; 3: important; 4: very important).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2025
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Luiza Laurentino de Albuquerque, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777393
- Sponsor's protocol ID
- D28343
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: In accordance with the Declaration of Helsinki, participant privacy and the confidentiality of personal information will be protected throughout the study. The informed consent obtained from participants does not include authorization for public sharing of individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia-Related Quality of Life and Exercise Motivation: Exploring Barriers and Facilitators to Physical Activity
- ClinicalTrials.gov ID
- NCT07777393
- Acronym / sponsor ID
- D28343
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 20 Aug 2026 (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.
The objective of this study is to evaluate possible correlations between motivation to engage in physical exercise and quality of life related to fibromyalgia, as well as the level of knowledge about fibromyalgia, and understand the factors that facilitate and the barriers to physical exercise.
Detailed description
This is a cross-sectional study in which data will be collected via an online questionnaire from Portuguese citizens with fibromyalgia. Recruitment will take place nationwide, with the project being publicized through organizations and associations related to fibromyalgia. The following questionnaires will be administered: questions regarding knowledge of fibromyalgia, the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), the Tampa Kinesiophobia Scale, the Portuguese version of the Behavioral Regulation in Exercise Questionnaire (BREQ-4), and the Importance of Characteristics Associated with Exercise.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portuguese citizens with fibromyalgia | – | –The form will be completed remotely and consists of 7 sections. These are: Acceptance of the Free, Informed, and Enlightened Consent Form (CLIE); Sociodemographic Information; Assessment of knowledge about the medical condition; The Fibromyalgia Impact Questionnaire Revised (FIQ-R) to assess the degree of impact of fibromyalgia; Tampa Kinesiophobia Scale to assess kinesiophobia; Motivation for physical exercise will be assessed using the Portuguese version of the Behavioral Regulation in Exercise Questionnaire (BREQ-4); and the importance of characteristics associated with exercise will be assessed using an adapted questionnaire. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with fibromyalgia
Key inclusion criteria (3 listed)
- medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria
- at least 18 years old
- Portuguese nationality
Key exclusion criteria (2 listed)
- medical condition that affects their ability to understand the text
- illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BREQ-4
Time frame: Day 1
Motivation for physical exercise will be assessed using the Portuguese version of the Behavioral Regulation in Exercise Questionnaire (BREQ-4). The questionnaire consists of 21 items, with responses rated on a 5-point Likert scale, where 0: Not true for me; 2: Sometimes true for me; 5: Often true for me. The 21 items are divided into seven factors according to their respective items, which are: amotivation; external regulation ; introjected regulation by avoidance; introjected regulation by approach; identified regulation; integrated regulation and intrinsic motivation. Results will be obtained for each factor/regulation, and the final score that is, the relative autonomy index.
4 secondary outcomes
Fibromyalgia Impact Questionnaire Revised
Time frame: Day 1
Fibromyalgia knowledge
Time frame: Day 1
Tampa Scale for Kinesiophobia
Time frame: Day 1
Barriers and characteristics associated to exercise
Time frame: Day 1
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 14 Sep 2026.
- Individual participant dataSharing planned: No. In accordance with the Declaration of Helsinki, participant privacy and the confidentiality of personal information will be protected throughout the study. The informed consent obtained from participants does not include authorization for public sharing of individual-level data.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by University of Beira Interior at 1 site in Portugal.
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 3 inclusion and 2 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 14 Sep 2026. 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 Portugal. 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?
BREQ-4 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.