FibromyalgiafibroIA 2NCT07674485
AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial
A study testing AI Combined (mobility and resistance training) and AI mobility in people with Fibromyalgia and Fibromyalgia (FM), run by Instituto Neurociencia Del Dolor.
Trial summary
Fibromyalgia (FM) is a primary chronic pain condition with an estimated prevalence of 3.3% in Chile. It is characterized by widespread musculoskeletal pain, fatigue, and impaired physical function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome
- What is being tested?
- AI Combined (mobility and resistance training) and AI mobility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 21 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older, of any sex/gender, with a documented medical diagnosis of fibromyalgia established in primary or secondary healthcare settings according to the American College of Rheumatology (ACR) criteria (Häuser \& Fitzcharles, 2018).
- Individuals able to understand and complete the self-report questionnaires used in the study.
- Individuals with access to a compatible electronic device (smartphone, tablet, or computer) and an internet connection required for participation in the telerehabilitation intervention.
- Individuals with basic digital literacy skills, defined as the ability to use electronic devices and interact with commonly used applications.
- Individuals who provide written informed consent to participate in the study.
Who cannot join
- Current participation in another structured therapeutic exercise program, whether supervised or unsupervised.
- Moderate to severe functional dependence in activities of daily living, defined as a score <60 on the Barthel Index.
- Absolute contraindications to therapeutic exercise, including hypertensive crisis (≥170/110 mmHg), dyspnea at rest, resting tachycardia, or severe glycemic abnormalities (blood glucose >250 mg/dL or <90 mg/dL in individuals receiving insulin therapy).
- Severe uncontrolled pain, defined as a score ≥8 on the Numeric Pain Rating Scale (NPRS) at rest.
- Medical or neurological conditions that significantly limit the safe performance of physical exercise, as determined by clinical assessment.
- Recent changes in fibromyalgia-specific pharmacological treatment within the previous 4 weeks, to ensure clinical stability throughout the intervention period.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation, With and Without Resistance Training, on Disease Impact and Physical Function in People With Fibromyalgia: A Randomized Controlled Trial (FibroIA 2.0)
Fibromyalgia (FM) is a primary chronic pain condition with an estimated prevalence of 3.3% in Chile. It is characterized by widespread musculoskeletal pain, fatigue, and impaired physical function. Although exercise therapy is considered the first-line intervention, barriers to access and poor adherence limit its effectiveness within the public healthcare system. This study evaluates the effectiveness of an Artificial Intelligence (AI)- and Computer Vision (CV)-assisted telerehabilitation platform called Rehbody. The aim is to determine whether real-time technology-driven feedback can overcome the limitations of traditional face-to-face rehabilitation models by improving disease impact and functional capacity in Chilean patients with fibromyalgia.
Read the detailed description
This superiority randomized controlled trial compares two digital telerehabilitation modalities with usual care. The intervention is delivered through the Rehbody platform, which uses computer vision algorithms to capture movement patterns through the camera of mobile devices, enabling the detection of joint angles and postural errors. The system provides immediate audiovisual feedback, ensuring safe and accurate exercise performance comparable to in-person supervision.
The primary statistical analysis will follow the Intention-to-Treat (ITT) principle using an Analysis of Covariance (ANCOVA) model, with baseline measurements included as covariates to reduce error variance. To assess the integrity of assessor blinding, the Bang Blinding Index will be administered at the end of Week 13. The study adheres to the SPIRIT 2013 and CONSORT 2010 reporting standards.
- Conditions
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome
- Being tested
- AI Combined (mobility and resistance training), AI mobility
- Keywords
- fibromyalgia, exercise, telehealth, artificial intelligence
- 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.
AI Combined (mobility and resistance training)Other
Also called AI exercise, Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation
Frequency: Twice weekly. Intensity: Borg Rating of Perceived Exertion (RPE) scale 4-6/10. Number of exercises: 11.
Sets and repetitions:
2 sets of 10-15 repetitions for mobility exercises. 10-12 repetitions for resistance training exercises. 4 repetitions for stretching exercises.
Rest interval: 20-60 seconds between sets. Total intervention duration: 12 weeks.
Mobility exercises (10-15 minutes):
Overhead Shoulder Raise (Bodyweight) Right Knee Raise with Arm Movement (Standing) Left Knee Raise with Arm Movement (Standing) Full Left Ankle Dorsiflexion-Plantarflexion (Standing) Full Right Ankle Dorsiflexion-Plantarflexion (Standing)
Resistance training exercises (15-20 minutes):
- Weighted Deadlift 7. Chair Squat 8. Weighted Lateral Shoulder Raise 9. Bilateral Dumbbell Bent-Over Row
Stretching exercises (5 minutes):
- Seated Cervical Flexion Stretch 11. Kneeling Prayer Stretch
AI mobilityOther
Also called AI Exercise
Frequency: Twice weekly. Intensity: Borg Rating of Perceived Exertion (RPE) scale 4-6/10. Number of exercises: 7.
Sets and repetitions:
2 sets of 10-15 repetitions for mobility exercises. 4 repetitions for stretching exercises.
Rest interval: 20-60 seconds between sets. Total intervention duration: 12 weeks.
Mobility exercises (10-15 minutes):
Overhead Shoulder Raise (Bodyweight) Right Knee Raise with Arm Movement (Standing) Left Knee Raise with Arm Movement (Standing) Full Left Ankle Dorsiflexion-Plantarflexion (Standing) Full Right Ankle Dorsiflexion-Plantarflexion (Standing)
Stretching exercises (5 minutes):
Seated Cervical Flexion Stretch Kneeling Prayer Stretch
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: AI Mobility | Experimental | Mobility and stretching exercise program delivered through the Rehbody platform (AI/CV-assisted) in addition to usual care. The program includes seven specific exercises. Receives: Other: AI mobility |
| Arm 2: AI Combined (mobility and resistance training) | Experimental | Cumulative intervention consisting of the mobility and stretching program described in Arm 1 plus AI/CV-assisted resistance training delivered through Rehbody, in addition to usual care. Total: 11 exercises. Receives: Other: AI Combined (mobility and resistance training) |
| Usual Care | No intervention | Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
The Fibromyalgia Impact Questionnaire-Revised (FIQ-R) is a 21-item self-reported instrument that assesses physical function, overall impact, and symptom severity in individuals with fibromyalgia. The Chilean validated version demonstrates excellent internal consistency (Cronbach's α = 0.91), good test-retest reliability (ICC = 0.90), and adequate convergent validity through significant correlations with pain intensity, pain interference, symptom severity, and health-related quality of life (Escobar, 2018). Total scores range from 0 to 100, with higher scores indicating greater disease impact. The questionnaire requires approximately 1.3 minutes to complete (Carrasco-Vega et al., 2023). A 14% change in the total FIQ-R score was considered the Minimal Detectable Change (MDC) (Bennett, Friend, et al., 2009). Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25).
Measured: 6 months
30-Second Sit-to-Stand Test (30s-STS) Performance
The 30-Second Sit-to-Stand Test (30s-STS) assesses lower-limb strength through a physical performance measure. It has demonstrated good to excellent test-retest reliability (ICC: 0.85-0.91), adequate known-groups validity for distinguishing individuals with and without fibromyalgia, and a minimal detectable change of ≥3 repetitions (Socorro-Cumplido et al., 2024). The test is associated with handgrip strength, muscle mass, balance, functional capacity, overall physical performance, and mobility- and quality of life-related outcomes (Kakavas et al., 2020; Khuna et al., 2024). Participants are instructed to perform as many sit-to-stand repetitions as possible within 30 seconds without using their arms, while the assessor records the total number of repetitions. The 30s-STS has been validated for remote administration in telehealth settings and for use in the Chilean population. Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25).
Measured: 6 months
Secondary outcomes (3)
Pain Catastrophizing
It will be assessed using The 4-item Pain Catastrophizing Scale (PCS-4) is a shortened version of the original 13-item Pain Catastrophizing Scale designed to assess catastrophic thinking related to pain in individuals with musculoskeletal conditions. The Spanish version has been validated in the Chilean population and demonstrates a unidimensional structure, high internal consistency (Cronbach's α = 0.84; McDonald's ω = 0.84), and evidence of validity through associations with pain intensity, pain interference, and kinesiophobia (Bascour-Sandoval et al., 2022). The questionnaire is self-administered and consists of four items rated on a 5-point Likert scale from 0 ("not at all") to 4 ("all the time"). Total scores range from 0 to 16, with higher scores indicating greater levels of pain catastrophizing. Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25).
Measured: 6 months
Exercise adherence
Exercise adherence refers to the extent to which participants comply with prescribed therapeutic exercise recommendations and sessions. It will be assessed using Section B of the Exercise Adherence Rating Scale (EARS), a six-item self-report instrument that evaluates adherence behaviors related to home-based exercise programs. Total scores range from 0 to 24, with higher scores indicating greater adherence to the prescribed exercise program. The Spanish version has demonstrated excellent psychometric properties, including high internal consistency (Cronbach's α = 0.93) and excellent test-retest reliability (ICC = 0.95) (Pérez-Huerta et al., 2025). Although the instrument has not been specifically validated in the Chilean population, it will be used as a complementary measure to support the interpretation of clinical outcomes. Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25).
Measured: 6 months
Sociodemographic and Baseline Clinical Characteristics
Sociodemographic and clinical characteristics will be collected to describe the study population and assess baseline comparability across trial arms. Sociodemographic variables will include age, gender, marital status, educational level, employment status, Previous exercise experience and access to technology. Clinical variables will include time since fibromyalgia diagnosis, pharmacological treatment, and comorbidities.
These variables will be analyzed descriptively. Continuous variables will be summarized using measures of central tendency and dispersion, whereas categorical variables will be reported as frequencies and proportions.
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start4 Jan 2027 (estimated)
- Primary completion28 Mar 2027 (estimated)
- Study completion21 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three-arm parallel-group randomized controlled trial with a 1:1:1 allocation ratio, superiority design, 3-month follow-up, and intention-to-treat analysis will be conducted. Participants will be randomly assigned to one of the three study groups. The study protocol has been developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines, ensuring that all critical aspects of the design, conduct, and reporting of the clinical trial are adequately addressed (Chan et al., 2013).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Neurociencia Del Dolor
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad San Sebastián, University of Alcala
- Responsible party
- Sponsor
- Investigators
- Daniel Pecos Martín, PhD, Study director, University of AlcalaJosé Manuel Gómez Pulido, PhD, Study director, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674485
- Sponsor's protocol ID
- FibroIA 2
- Acronym
- fibroIA 2
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it's not necessary
Publications
Perez-Huerta BD, Diaz-Pulido B, Godinez-Jaimes F, Gomez-Rodriguez R, Godfrey EL, Sanchez-Sanchez B. Cultural adaptation and psychometric validation of the exercise adherence Rating scale Mexican Spanish version (EARS-Mx). Musculoskelet Sci Pract. 2025 Jun;77:103308. doi: 10.1016/j.msksp.2025.103308. Epub 2025 Mar 7.
PubMed 40090120Bascour-Sandoval C, Albayay J, Martinez-Molina A, Opazo-Sepulveda A, Lacoste-Abarzua C, Bielefeldt-Astudillo D, Gajardo-Burgos R, Galvez-Garcia G. Psychometric Properties of the PCS and the PCS-4 in Individuals With Musculoskeletal Pain. Psicothema. 2022 May;34(2):323-331. doi: 10.7334/psicothema2021.21.
PubMed 35485547Carrasco-Vega E, Martinez-Moya M, Barni L, Guiducci S, Nacci F, Gonzalez-Sanchez M. Questionnaires for the subjective evaluation of patients with fibromyalgia: a systematic review. Eur J Phys Rehabil Med. 2023 Jun;59(3):353-363. doi: 10.23736/S1973-9087.23.07762-6. Epub 2023 May 15.
PubMed 37184415Socorro-Cumplido JL, Chaler J, Almirall M, Sanchez-Raya J, Cano M, Roman-Vinas B. Psychometric properties of performance based tests in patients with Fibromyalgia: A systematic review. J Pain. 2025 Apr;29:104749. doi: 10.1016/j.jpain.2024.104749. Epub 2024 Nov 28.
PubMed 39615810Duran J, Tejos-Bravo M, Cid V, Ferreccio C, Calvo M. Chronic pain in Chile: first prevalence report of noncancer chronic pain, fibromyalgia, and neuropathic pain and its associated factors. Pain. 2023 Aug 1;164(8):1852-1859. doi: 10.1097/j.pain.0000000000002886. Epub 2023 Mar 9.
PubMed 36893316Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
PubMed 27916278Smith BH, Fors EA, Korwisi B, Barke A, Cameron P, Colvin L, Richardson C, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: applicability in primary care. Pain. 2019 Jan;160(1):83-87. doi: 10.1097/j.pain.0000000000001360.
PubMed 30586075
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation, With and Without Resistance Training, on Disease Impact and Physical Function in People With Fibromyalgia: A Randomized Controlled Trial (FibroIA 2.0)
- ClinicalTrials.gov ID
- NCT07674485
- Acronym / sponsor ID
- fibroIA 2 / FibroIA 2
- Conditions
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome
- Keywords
- fibromyalgia, exercise, telehealth, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Instituto Neurociencia Del DolorUniversity, hospital or other
- Collaborators
- Universidad San Sebastián, University of Alcala
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 21 Jun 2027 (estimated)
- First posted
- 29 Jun 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.
Fibromyalgia (FM) is a primary chronic pain condition with an estimated prevalence of 3.3% in Chile. It is characterized by widespread musculoskeletal pain, fatigue, and impaired physical function. Although exercise therapy is considered the first-line intervention, barriers to access and poor adherence limit its effectiveness within the public healthcare system. This study evaluates the effectiveness of an Artificial Intelligence (AI)- and Computer Vision (CV)-assisted telerehabilitation platform called Rehbody. The aim is to determine whether real-time technology-driven feedback can overcome the limitations of traditional face-to-face rehabilitation models by improving disease impact and functional capacity in Chilean patients with fibromyalgia.
Detailed description
This superiority randomized controlled trial compares two digital telerehabilitation modalities with usual care. The intervention is delivered through the Rehbody platform, which uses computer vision algorithms to capture movement patterns through the camera of mobile devices, enabling the detection of joint angles and postural errors. The system provides immediate audiovisual feedback, ensuring safe and accurate exercise performance comparable to in-person supervision.
The primary statistical analysis will follow the Intention-to-Treat (ITT) principle using an Analysis of Covariance (ANCOVA) model, with baseline measurements included as covariates to reduce error variance. To assess the integrity of assessor blinding, the Bang Blinding Index will be administered at the end of Week 13. The study adheres to the SPIRIT 2013 and CONSORT 2010 reporting standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A three-arm parallel-group randomized controlled trial with a 1:1:1 allocation ratio, superiority design, 3-month follow-up, and intention-to-treat analysis will be conducted. Participants will be randomly assigned to one of the three study groups. The study protocol has been developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines, ensuring that all critical aspects of the design, conduct, and reporting of the clinical trial are adequately addressed (Chan et al., 2013).
| Arm | Type | Receives |
|---|---|---|
| Arm 1: AI Mobility | Experimental | Other: AI mobilityMobility and stretching exercise program delivered through the Rehbody platform (AI/CV-assisted) in addition to usual care. The program includes seven specific exercises. |
| Arm 2: AI Combined (mobility and resistance training) | Experimental | Other: AI Combined (mobility and resistance training)Cumulative intervention consisting of the mobility and stretching program described in Arm 1 plus AI/CV-assisted resistance training delivered through Rehbody, in addition to usual care. Total: 11 exercises. |
| Usual Care | No intervention | –Continuation of usual care, including medical management, pharmacological treatment, and conventional physiotherapy when applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older, of any sex/gender, with a documented medical diagnosis of fibromyalgia established in primary or secondary healthcare settings according to the American College of Rheumatology (ACR) criteria (Häuser \& Fitzcharles, 2018).
- Individuals able to understand and complete the self-report questionnaires used in the study.
- Individuals with access to a compatible electronic device (smartphone, tablet, or computer) and an internet connection required for participation in the telerehabilitation intervention.
- Individuals with basic digital literacy skills, defined as the ability to use electronic devices and interact with commonly used applications.
- Individuals who provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Current participation in another structured therapeutic exercise program, whether supervised or unsupervised.
- Moderate to severe functional dependence in activities of daily living, defined as a score <60 on the Barthel Index.
- Absolute contraindications to therapeutic exercise, including hypertensive crisis (≥170/110 mmHg), dyspnea at rest, resting tachycardia, or severe glycemic abnormalities (blood glucose >250 mg/dL or <90 mg/dL in individuals receiving insulin therapy).
- Severe uncontrolled pain, defined as a score ≥8 on the Numeric Pain Rating Scale (NPRS) at rest.
- Medical or neurological conditions that significantly limit the safe performance of physical exercise, as determined by clinical assessment.
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 |
|---|---|---|
| AI Combined (mobility and resistance training)Also: AI exercise, Artificial Intelligence- and Computer Vision-Assisted TelerehabilitationFrequency: Twice weekly. Intensity: Borg Rating of Perceived Exertion (RPE) scale 4-6/10. Number of exercises: 11. Sets and repetitions: 2 sets of 10-15 repetitions for mobility exercises. 10-12 repetitions for resistance training exercises. 4 repetitions for stretching exercises. Rest interval: 20-60 seconds between sets. Total intervention duration: 12 weeks. Mobility exercises (10-15 minutes): Overhead Shoulder Raise (Bodyweight) Right Knee Raise with Arm Movement (Standing) Left Knee Raise with Arm Movement (Standing) Full Left Ankle Dorsiflexion-Plantarflexion (Standing) Full Right Ankle Dorsiflexion-Plantarflexion (Standing) Resistance training exercises (15-20 minutes): 6. Weighted Deadlift 7. Chair Squat 8. Weighted Lateral Shoulder Raise 9. Bilateral Dumbbell Bent-Over Row Stretching exercises (5 minutes): 10. Seated Cervical Flexion Stretch 11. Kneeling Prayer Stretch | Other | Arm 2: AI Combined (mobility and resistance training) |
| AI mobilityAlso: AI ExerciseFrequency: Twice weekly. Intensity: Borg Rating of Perceived Exertion (RPE) scale 4-6/10. Number of exercises: 7. Sets and repetitions: 2 sets of 10-15 repetitions for mobility exercises. 4 repetitions for stretching exercises. Rest interval: 20-60 seconds between sets. Total intervention duration: 12 weeks. Mobility exercises (10-15 minutes): Overhead Shoulder Raise (Bodyweight) Right Knee Raise with Arm Movement (Standing) Left Knee Raise with Arm Movement (Standing) Full Left Ankle Dorsiflexion-Plantarflexion (Standing) Full Right Ankle Dorsiflexion-Plantarflexion (Standing) Stretching exercises (5 minutes): Seated Cervical Flexion Stretch Kneeling Prayer Stretch | Other | Arm 1: AI Mobility |
Primary outcome
Fibromyalgia Impact Questionnaire-Revised (FIQ-R)
Time frame: 6 months
The Fibromyalgia Impact Questionnaire-Revised (FIQ-R) is a 21-item self-reported instrument that assesses physical function, overall impact, and symptom severity in individuals with fibromyalgia. The Chilean validated version demonstrates excellent internal consistency (Cronbach's α = 0.91), good test-retest reliability (ICC = 0.90), and adequate convergent validity through significant correlations with pain intensity, pain interference, symptom severity, and health-related quality of life (Escobar, 2018). Total scores range from 0 to 100, with higher scores indicating greater disease impact. The questionnaire requires approximately 1.3 minutes to complete (Carrasco-Vega et al., 2023). A 14% change in the total FIQ-R score was considered the Minimal Detectable Change (MDC) (Bennett, Friend, et al., 2009). Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25).
30-Second Sit-to-Stand Test (30s-STS) Performance
Time frame: 6 months
The 30-Second Sit-to-Stand Test (30s-STS) assesses lower-limb strength through a physical performance measure. It has demonstrated good to excellent test-retest reliability (ICC: 0.85-0.91), adequate known-groups validity for distinguishing individuals with and without fibromyalgia, and a minimal detectable change of ≥3 repetitions (Socorro-Cumplido et al., 2024). The test is associated with handgrip strength, muscle mass, balance, functional capacity, overall physical performance, and mobility- and quality of life-related outcomes (Kakavas et al., 2020; Khuna et al., 2024). Participants are instructed to perform as many sit-to-stand repetitions as possible within 30 seconds without using their arms, while the assessor records the total number of repetitions. The 30s-STS has been validated for remote administration in telehealth settings and for use in the Chilean population. Assessments will be conducted at baseline (Week 0), post-intervention (Week 13), and follow-up (Week 25).
3 secondary outcomes
Pain Catastrophizing
Time frame: 6 months
Exercise adherence
Time frame: 6 months
Sociodemographic and Baseline Clinical Characteristics
Time frame: Week 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 40090120Perez-Huerta BD, Diaz-Pulido B, Godinez-Jaimes F, Gomez-Rodriguez R, Godfrey EL, Sanchez-Sanchez B. Cultural adaptation and psychometric validation of the exercise adherence Rating scale Mexican Spanish version (EARS-Mx). Musculoskelet Sci Pract. 2025 Jun;77:103308. doi: 10.1016/j.msksp.2025.103308. Epub 2025 Mar 7.
- Background: PubMed 35485547Bascour-Sandoval C, Albayay J, Martinez-Molina A, Opazo-Sepulveda A, Lacoste-Abarzua C, Bielefeldt-Astudillo D, Gajardo-Burgos R, Galvez-Garcia G. Psychometric Properties of the PCS and the PCS-4 in Individuals With Musculoskeletal Pain. Psicothema. 2022 May;34(2):323-331. doi: 10.7334/psicothema2021.21.
- Background: PubMed 37184415Carrasco-Vega E, Martinez-Moya M, Barni L, Guiducci S, Nacci F, Gonzalez-Sanchez M. Questionnaires for the subjective evaluation of patients with fibromyalgia: a systematic review. Eur J Phys Rehabil Med. 2023 Jun;59(3):353-363. doi: 10.23736/S1973-9087.23.07762-6. Epub 2023 May 15.
- Background: PubMed 39615810Socorro-Cumplido JL, Chaler J, Almirall M, Sanchez-Raya J, Cano M, Roman-Vinas B. Psychometric properties of performance based tests in patients with Fibromyalgia: A systematic review. J Pain. 2025 Apr;29:104749. doi: 10.1016/j.jpain.2024.104749. Epub 2024 Nov 28.
- Background: PubMed 36893316Duran J, Tejos-Bravo M, Cid V, Ferreccio C, Calvo M. Chronic pain in Chile: first prevalence report of noncancer chronic pain, fibromyalgia, and neuropathic pain and its associated factors. Pain. 2023 Aug 1;164(8):1852-1859. doi: 10.1097/j.pain.0000000000002886. Epub 2023 Mar 9.
- Background: PubMed 27916278Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.
- Background: PubMed 30586075Smith BH, Fors EA, Korwisi B, Barke A, Cameron P, Colvin L, Richardson C, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: applicability in primary care. Pain. 2019 Jan;160(1):83-87. doi: 10.1097/j.pain.0000000000001360.
- Individual participant dataSharing planned: No. it's not necessary
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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.
Daniel Pecos Martín, PhD study director
University of Alcala
José Manuel Gómez Pulido, PhD study director
University of Alcala
Questions about this trial
What is this clinical trial studying?
A study testing AI Combined (mobility and resistance training) and AI mobility in people with Fibromyalgia and Fibromyalgia (FM), run by Instituto Neurociencia Del Dolor.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romualdo Luciano Ordóñez Vega, Master, and PhD student (+56982256426, kine.ordonez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire-Revised (FIQ-R) (time frame: 6 months). The study lists 2 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 NCT07674485, which also lists 7 linked publications.
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 1 Jul 2026.