FibromyalgiaNCT05993663
Effectiveness of an Intervention Based on Arts In Health in the Quality of Life of People With Fibromyalgia.
A study testing Arts in health group intervention in people with Fibromyalgia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The aim of this intervention is to measure the impact of a 12-session intervention with Arts in Health methodology on the quality of life of the population with fibromyalgia. The main questions it aims to answer are: To know if the methodology of Arts in Health is effective for the improvement of the functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Arts in health group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2023to 30 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with fibromyalgia (M79.1) or diagnosed with fibromyalgia and chronic fatigue syndrome (T78.40 and M79.7)
- Over 18 years old.
- They agree to participate in the study and sign the informed consent.
Who cannot join
- Serious concomitant rheumatological pathology, that is to say, that this involves a much more important functional disability than that caused by the fibromyalgia pathology itself.
- Serious psychiatric pathology [according to V Diagnostical and Statical Manual of Mental Disorders (DSM-V) criteria] that could make it difficult to participate in the sessions and follow the study. Or that due to his psychiatric diagnosis, participation in a group was not advisable because of the negative impact it could cause.
- Having previously participated in the group education project for people with fibromyalgia in Figueres Health Care Center.
- Users who present a language barrier that makes good communication impossible.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
ABS Figueres
Figueres, Girona, 17600
Maria Carrillo, Manager, 972 67 76 31, eap_figueres.girona.ics@gencat.cat
Judit Ferragutcasas Butiñà, physician
About this study
Official title: Museums as Health Spaces: Design and Evaluation of the Effectiveness of an Arts in Health Intervention to Improve the Quality of Life and Functional Capacity Regarding the Pain of People With Fibromyalgia. Mixed Methodology Study.
The aim of this intervention is to measure the impact of a 12-session intervention with Arts in Health methodology on the quality of life of the population with fibromyalgia.
The main questions it aims to answer are:
Read more
- To know if the methodology of Arts in Health is effective for the improvement of the functional capacity of people with fibromyalgia
- Which are the most effective techniques within this intervention
During the intervention, the participants will take part in mindfulness sessions, dance, visual thinking strategies, aimed at a greater understanding of the disease and the development of healthy habits.
The results of this intervention are compared with a control group, in which the same scales and instruments will be passed in the same period of time. To complete the information gathering, a focus group will be held to obtain qualitative information about the experience of the participants.
Read the detailed description
Arts in Health is a methodology that seeks to use the power of arts and culture to improve people's health and well-being. To develop it, collaboration is promoted between health professionals and those in the artistic and cultural fields.
In accordance with the Arts in Health strategy of the Catalan Health Institute, the primary health care professionals in Figueres have started a joint project along Museu de l'Empordà, a local museum, to address fibromyalgia from this perspective.
The objectives are to quantitatively analyze the effectiveness of an Arts in Health intervention to improve the functional capacity with respect to pain and the quality of life of people with fibromyalgia. Also, qualitatively assess the experience of the participants and explore how they value the impact of cultural activities on health.
Joint work has been carried out to produce a guide where, through different modalities of Art, the symptoms and needs of people suffering from fibromyalgia will be addressed. Affected people have also collaborated in this process. With the results of this work, the content of the Intervention has been designed.
From here, a mixed methodology study is proposed through a randomized clinical trial for people affected by fibromyalgia. For the quantitative analysis, quality of life tests and a disability perception test due to pain, (FIQ-R), will be taken before, at the end and 6 months after the intervention. For the qualitative analysis, focus groups will be formed at the end of the intervention.
- Conditions
- Fibromyalgia
- Being tested
- Arts in health group intervention
- Keywords
- Fibromyalgia, Arts in Health, Mindfulness, Visual Thinking Strategies, Revised Fibromyalgia Impact Questionnaire (FIQ-R)
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arts in health group interventionBehavioural
12 sessions using the Arts in Health methodology with the aim of having a better understanding of the disease, developing healthy lifestyle habits and greater emotional intelligence. Visual thinking strategies, game based activities, mindfulness and dance will be used
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size. Receives: Behavioral: Arts in health group intervention |
| Control group | No intervention | Control groups. Participants in these groups won't receive any group intervention, just regular health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Measured: The first and last days of the intervention and 6 months after intervention.
Life quality
Quality of life perceived by the participants, measured with the EUROQOL
Measured: The first and last days of the intervention and 6 months after intervention.
Secondary outcomes (6)
Anxiety
Assessment of anxiety with the Goldberg scale
Measured: 1 month before the intervention, last intervention day and 6 months after intervention.
Emotional well-being
Assessment of emotional well-being with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)
Measured: 1 month before the intervention, last intervention day and 6 months after intervention.
Depression
Depression
Measured: 1 month before the intervention, last intervention day and 6 months after intervention.
Social support
Assessment of perceived social support with the Oslo Social Support Scale (OSLO-3) scale
Measured: 1 month before the intervention, last intervention day and 6 months after intervention.
Drug consumption
Painkillers and psychotropic drugs consumed
Measured: During the 6 months before the intervention and the 6 months after the intervention.
Health care professional appointments.
Assistance to health services
Measured: During the 6 months before the intervention, during the interventions and the 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start2 Oct 2023 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Agència de Salut Pública de Catalunya (ASPCAT), Institut Català de la Salut, Servei de Museus i Protecció de Béns Mobles, Museu de l'Empordà, Adhoc Cultura
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993663
- Sponsor's protocol ID
- 23/133-P
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bravo C, Skjaerven LH, Guitard Sein-Echaluce L, Catalan-Matamoros D. Effectiveness of movement and body awareness therapies in patients with fibromyalgia: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2019 Oct;55(5):646-657. doi: 10.23736/S1973-9087.19.05291-2. Epub 2019 May 15.
PubMed 31106558Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
PubMed 2306288Bellato E, Marini E, Castoldi F, Barbasetti N, Mattei L, Bonasia DE, Blonna D. Fibromyalgia syndrome: etiology, pathogenesis, diagnosis, and treatment. Pain Res Treat. 2012;2012:426130. doi: 10.1155/2012/426130. Epub 2012 Nov 4.
PubMed 23213512Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
PubMed 21285161Glombiewski JA, Sawyer AT, Gutermann J, Koenig K, Rief W, Hofmann SG. Psychological treatments for fibromyalgia: a meta-analysis. Pain. 2010 Nov;151(2):280-295. doi: 10.1016/j.pain.2010.06.011. Epub 2010 Aug 19.
PubMed 20727679Bernardy K, Fuber N, Kollner V, Hauser W. Efficacy of cognitive-behavioral therapies in fibromyalgia syndrome - a systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2010 Oct;37(10):1991-2005. doi: 10.3899/jrheum.100104. Epub 2010 Aug 3.
PubMed 20682676Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
PubMed 27377815Mayorga Buiza, M. J. et al. Impacto de un programa de educación sanitaria en pacientes con fibromialgia. Rev. la Soc. Española del Dolor 17, 227-232 (2010).
García-Campayo, J. et al. Intervención psicoeducativa en pacientes con fibromialgia en Atención Primaria: Efectividad y diferencias entre terapia individual y grupal. Cuad. Med. Psicosomática 73, 32-41 (2005)
van Koulil S, Effting M, Kraaimaat FW, van Lankveld W, van Helmond T, Cats H, van Riel PL, de Jong AJ, Haverman JF, Evers AW. Cognitive-behavioural therapies and exercise programmes for patients with fibromyalgia: state of the art and future directions. Ann Rheum Dis. 2007 May;66(5):571-81. doi: 10.1136/ard.2006.054692. Epub 2006 Aug 17.
PubMed 16916856Drozd M, Marzęda M, Blicharz A, Czarnota J, Piecewicz-Szczęsna H. Unclear etiology and current hypotheses of the pathogenesis of fibromyalgia. J Educ Health Sport [Internet]. 2020 Sep. 15 [cited 2023 Jun. 8];10(9):338-44.
Daykin, N. (2016). Arts for Health and Wellbeing. An Evaluation Framework.
Fancourt D, Finn S. What is the evidence on the role of the arts in improving health and well-being? A scoping review [Internet]. Copenhagen: WHO Regional Office for Europe; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK553773/
PubMed 32091683Clift S, Camic PM. Oxford Textbook of Creative Arts, Health, and Wellbeing: International Perspectives on Practice, Policy, and Research. Oxford: Oxford University Press; 2016
Siles S, Castillejo M, Fernández J, Larraín A, Azcona C. Prácticas artísticas en contextos de salud comunitaria: cinco experiencias de arte y salud en los Centros Municipales de Salud Comunitaria de Madrid. Arteterapia [Internet]. 2020 [consultat el 07 de març de 2023]; 15: 135-146. Avaliable at: https://revistas.ucm.es/index.php/ARTE/article/view/65388/4564456554480
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Museums as Health Spaces: Design and Evaluation of the Effectiveness of an Arts in Health Intervention to Improve the Quality of Life and Functional Capacity Regarding the Pain of People With Fibromyalgia. Mixed Methodology Study.
- ClinicalTrials.gov ID
- NCT05993663
- Acronym / sponsor ID
- 23/133-P
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Arts in Health, Mindfulness, Visual Thinking Strategies, Revised Fibromyalgia Impact Questionnaire (FIQ-R)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Agència de Salut Pública de Catalunya (ASPCAT), Institut Català de la Salut, Servei de Museus i Protecció de Béns Mobles, Museu de l'Empordà, Adhoc Cultura
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Aug 2023 (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 aim of this intervention is to measure the impact of a 12-session intervention with Arts in Health methodology on the quality of life of the population with fibromyalgia.
The main questions it aims to answer are:
- To know if the methodology of Arts in Health is effective for the improvement of the functional capacity of people with fibromyalgia
- Which are the most effective techniques within this intervention
During the intervention, the participants will take part in mindfulness sessions, dance, visual thinking strategies, aimed at a greater understanding of the disease and the development of healthy habits.
The results of this intervention are compared with a control group, in which the same scales and instruments will be passed in the same period of time. To complete the information gathering, a focus group will be held to obtain qualitative information about the experience of the participants.
Detailed description
Arts in Health is a methodology that seeks to use the power of arts and culture to improve people's health and well-being. To develop it, collaboration is promoted between health professionals and those in the artistic and cultural fields.
In accordance with the Arts in Health strategy of the Catalan Health Institute, the primary health care professionals in Figueres have started a joint project along Museu de l'Empordà, a local museum, to address fibromyalgia from this perspective.
The objectives are to quantitatively analyze the effectiveness of an Arts in Health intervention to improve the functional capacity with respect to pain and the quality of life of people with fibromyalgia. Also, qualitatively assess the experience of the participants and explore how they value the impact of cultural activities on health.
Joint work has been carried out to produce a guide where, through different modalities of Art, the symptoms and needs of people suffering from fibromyalgia will be addressed. Affected people have also collaborated in this process. With the results of this work, the content of the Intervention has been designed.
From here, a mixed methodology study is proposed through a randomized clinical trial for people affected by fibromyalgia. For the quantitative analysis, quality of life tests and a disability perception test due to pain, (FIQ-R), will be taken before, at the end and 6 months after the intervention. For the qualitative analysis, focus groups will be formed at the end of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Arts in health group interventionIntervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size. |
| Control group | No intervention | –Control groups. Participants in these groups won't receive any group intervention, just regular health care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with fibromyalgia (M79.1) or diagnosed with fibromyalgia and chronic fatigue syndrome (T78.40 and M79.7)
- Over 18 years old.
- They agree to participate in the study and sign the informed consent.
Key exclusion criteria (4 listed)
- Serious concomitant rheumatological pathology, that is to say, that this involves a much more important functional disability than that caused by the fibromyalgia pathology itself.
- Serious psychiatric pathology [according to V Diagnostical and Statical Manual of Mental Disorders (DSM-V) criteria] that could make it difficult to participate in the sessions and follow the study. Or that due to his psychiatric diagnosis, participation in a group was not advisable because of the negative impact it could cause.
- Having previously participated in the group education project for people with fibromyalgia in Figueres Health Care Center.
- Users who present a language barrier that makes good communication impossible.
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 |
|---|---|---|
| Arts in health group intervention12 sessions using the Arts in Health methodology with the aim of having a better understanding of the disease, developing healthy lifestyle habits and greater emotional intelligence. Visual thinking strategies, game based activities, mindfulness and dance will be used | Behavioural | Intervention group |
Primary outcome
Functional capacity
Time frame: The first and last days of the intervention and 6 months after intervention.
Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Life quality
Time frame: The first and last days of the intervention and 6 months after intervention.
Quality of life perceived by the participants, measured with the EUROQOL
6 secondary outcomes
Anxiety
Time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
Emotional well-being
Time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
Depression
Time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
Social support
Time frame: 1 month before the intervention, last intervention day and 6 months after intervention.
Drug consumption
Time frame: During the 6 months before the intervention and the 6 months after the intervention.
Health care professional appointments.
Time frame: During the 6 months before the intervention, during the interventions and the 6 months after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 31106558Bravo C, Skjaerven LH, Guitard Sein-Echaluce L, Catalan-Matamoros D. Effectiveness of movement and body awareness therapies in patients with fibromyalgia: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2019 Oct;55(5):646-657. doi: 10.23736/S1973-9087.19.05291-2. Epub 2019 May 15.
- Background: PubMed 2306288Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
- Background: PubMed 23213512Bellato E, Marini E, Castoldi F, Barbasetti N, Mattei L, Bonasia DE, Blonna D. Fibromyalgia syndrome: etiology, pathogenesis, diagnosis, and treatment. Pain Res Treat. 2012;2012:426130. doi: 10.1155/2012/426130. Epub 2012 Nov 4.
- Background: PubMed 21285161Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
- Background: PubMed 20727679Glombiewski JA, Sawyer AT, Gutermann J, Koenig K, Rief W, Hofmann SG. Psychological treatments for fibromyalgia: a meta-analysis. Pain. 2010 Nov;151(2):280-295. doi: 10.1016/j.pain.2010.06.011. Epub 2010 Aug 19.
- Background: PubMed 20682676Bernardy K, Fuber N, Kollner V, Hauser W. Efficacy of cognitive-behavioral therapies in fibromyalgia syndrome - a systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2010 Oct;37(10):1991-2005. doi: 10.3899/jrheum.100104. Epub 2010 Aug 3.
- Background: PubMed 27377815Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
- BackgroundMayorga Buiza, M. J. et al. Impacto de un programa de educación sanitaria en pacientes con fibromialgia. Rev. la Soc. Española del Dolor 17, 227-232 (2010).
- BackgroundGarcía-Campayo, J. et al. Intervención psicoeducativa en pacientes con fibromialgia en Atención Primaria: Efectividad y diferencias entre terapia individual y grupal. Cuad. Med. Psicosomática 73, 32-41 (2005)
- Background: PubMed 16916856van Koulil S, Effting M, Kraaimaat FW, van Lankveld W, van Helmond T, Cats H, van Riel PL, de Jong AJ, Haverman JF, Evers AW. Cognitive-behavioural therapies and exercise programmes for patients with fibromyalgia: state of the art and future directions. Ann Rheum Dis. 2007 May;66(5):571-81. doi: 10.1136/ard.2006.054692. Epub 2006 Aug 17.
- BackgroundDrozd M, Marzęda M, Blicharz A, Czarnota J, Piecewicz-Szczęsna H. Unclear etiology and current hypotheses of the pathogenesis of fibromyalgia. J Educ Health Sport [Internet]. 2020 Sep. 15 [cited 2023 Jun. 8];10(9):338-44.
- BackgroundDaykin, N. (2016). Arts for Health and Wellbeing. An Evaluation Framework.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arts in health group intervention in people with Fibromyalgia, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judit Ferragutcasas Butiña (600234302, jferragutcasa.girona.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: The first and last days of the intervention and 6 months after intervention.). 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 NCT05993663, which also lists 48 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 15 Aug 2023.