FibromyalgiaSYNCHRONIZE +NCT05719493
Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)
A study testing multicomponent treatment in people with Fibromyalgia and Chronic Fatigue Syndrome, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome
- What is being tested?
- multicomponent treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 4 Oct 2021to Dec 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People aged 18-65, recent diagnosis of Fibromyalgia (M79.1) (<10 years), or diagnosis of Fibromyalgia and Chronic Fatigue Syndrome (M79 .7 and G93.3), with availability, motivation and interest in the intervention.
Who cannot join
- not meeting the inclusion criteria, being participating in other group interventions aimed at the treatment of these syndromes, presence of severe mental comorbidity or other relevant medical disorders or pathologies that may interfere with the evaluation of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Primary Care Intervention in Fibromyalgia and Chronic Fatigue Syndrome: SYNCHRONIZE + Mixed Methods Study Protocol.
Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.
Read the detailed description
The investigators will perform a mixed study through a randomized clinical trial in Catalonian Primary Care with patients diagnosed of Fibromyalgia (M79.7) or both Fibromyalgia and Chronic Fatigue Syndrome (G93.3). The control group will follow the usual clinical practice and the intervention group, the usual practice plus the studied intervention (12 hours in 4 days). The intervention (based on nutrition, chronobiology and physical exercise) will be designed taking into account participant's opinion through focus groups. In both groups, quality of life (EuroQol-5D), as well as MFI, VAS pain, PSQI, erMEDAS-17, BRIAN, REGICOR-Short, FIQR and HADs questionnaires will be collected, prior to the intervention, and 1, 3, 6 and 12 months post-intervention. Food intake, body composition, resistance and strength will also be evaluated. The effect size will be calculated using Cohen's d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. In addition, a qualitative analysis with a descriptive phenomenological perspective from post-intervention focus groups of participants and professionals will be done.
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Being tested
- multicomponent treatment
- Keywords
- multicomponent intervention, nutrition, chronobiology, physical exercise, quality of life, primary health care
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent treatmentOther
The intervention to be evaluated consists of 4 group sessions carried out in two weeks, 6 hours per week divided in 2 days (a total of 12 hours), of active education in nutrition, chronobiology and physical exercise in people diagnosed with Chronic Fatigue Syndrome and Fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| multicomponent-treatment no benefiting group | No intervention | Participants in the control group will receive the care from the usual clinical practice |
| munticomponent-treatment benefiting group | Experimental | Partcipants in the intervention group will receive the care from the usual practice plus the studied intervention. Receives: Other: multicomponent treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in quality of life
to be evaluated with the EuroQol-5D questionnaire. It will be measured by a scale Likert: 0 (worst health) to 100 (better health) and a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; with five levels of severity in each dimension: no problems, mild problems, moderate problems, severe problems, and extreme problems/impossibility.
Measured: change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention
Secondary outcomes (15)
change in fatigue indicator
to be evaluated with the "Multidimensional Fatigue Inventory" (MFI) questionnaire (Smet et al., 1995). It will measure 20-items. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.
Measured: change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention
change in sleep quality and insomnia indicator
Sleep quality and insomnia will be assessed with the Pittsburgh Sleep Quality Index (PSQI-19 items) (Buysse et al., 1989). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention
change in pain indicator
To assess pain, the VAS questionnaire will be used (Marques et al., 2008). It will be measured by a scale Likert: 0 (absence of pain) to 10 (worst possible pain).
Measured: change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention
change in adherence to the Mediterranean diet
adherence to the Mediterranean diet will be assessed with the erMEDAS-17-item questionnaire (PREDIMED Plus; Schröder et al., 2021). Adherence to dietary habits characteristic of a MedDiet is scored, in each item, with 1 point and the opposite, with 0 points. Total scoring scale goes from 0 to 17 points, where 0 means no adherence and 17, maximum adherence. The score can be also classified into approximate tertiles: low (≤ 7), medium (8-10), and high (11-17).
Measured: change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention
change in physical exercise practice and sedentary lifestyle
physical exercise practice and sedentary lifestyle will be assessed with the REGICOR-Short questionnaire (Molina et al., 2017). The short questionnaire estimates energy expenditure in total physical activity and by intensity (light, moderate, vigorous) following REGICOR-Short algoritmes, and includes 2 questions about sedentary behavior and a question about occupational physical activity. We will evaluate change in amount of time dedicated to physical activity (minutes or hours) and physical activity intensity per week (energy expenditure or METs x min/week), and change in sedentarism (number of hours per week doing sedentary activities).
Measured: change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention
change in circadian biological rhythm
the circadian biological rhythm will be assessed with the "Biological Rhythms Interview of Assessment in Neuropsychiatry" (BRIAN) questionnaire (Giglio et al., 2008). The BRIAN includes 18-items to investigate four main areas related to circadian rhythm disturbance: sleep, activities, social rhythms and eating patterns. Items are rated using a 4-point scale, (1)= no difficulty, (2)= mild difficulty, (3)= moderate difficulty, and (4) =severe difficulty. The BRIAN scores thus range from 1 to 72, where the higher scores suggest severe circadian rhythm disturbance.
Measured: change from circadian biological rhythm at 1, 3, 6 and 12 months after the beginning of the intervention
change in functional impact of fibromyalgia
to be evaluatedwith the Revised Questionnaire on the Impact of Fibromyalgia (FIQR). It will be measured by a scale Likert: 0 (best) to 100 (worst).
Measured: change from functional impact of fibromyalgia at 1, 3, 6 and 12 months after the beginning of the intervention
change in mood indicator (anxiety)
To be evaluated with the Hospital Anxiety and Depression Scale (HADS) questionnaire. The scale llikert punctuates from 0 to 21 (8 to 10 indicates a doubtful case of anxiety; more than 11 indicates a probable case of anxiety)
Measured: change from mood indicator (anxiety) at 1, 3, 6 and 12 months after the beginning of the intervention
change in food intake
Will be evaluate through R24h and FFQ (Rodríguez et al., 2008). The R24h will be evaluated qualitatively (number of intakes/day; intake composition, etc.) while the FFQ register weekly and monthly intake of different food (times per week; times per month), and will evaluated qualitatively.
Measured: change from food intake at at 1, 3, 6 and 12 months after the beginning of the intervention
change in body mass index (BMI)
Weight and height will be combined to report BMI in Kg/m2.
Measured: change from BMI at 1, 3, 6 and 12 months after the beginning of the intervention
change in body fat
Body fat (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.
Measured: change from body fat at 1, 3, 6 and 12 months after the beginning of the intervention
change in skeletal muscle
Skeletal muscle (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.
Measured: change from skeletal muscle at 1, 3, 6 and 12 months after the beginning of the intervention
change in endurance
Endurance will be evaluated with the ''6-min walk test' (Rikli and Jones, 1999). This test involves determining the maximum distance (m) that can be walked in 6 min .
Measured: change from endurance at 1, 3, 6 and 12 months after the beginning of the intervention
change in lower body muscular strength
The ''30-s chair stand test''(Rikli and Jones, 1999) involves counting the number of times within 30 s that an individual can rise to a full stand from a seated position with the back straight and the feet flat on the floor, without pushing off with the arms.
Measured: change from lower body muscular strength at 1, 3, 6 and 12 months after the beginning of the intervention
change in upper body muscular strength
The handgrip strength will be assessed using a "hand dynamometer". The subject continuously and gradually squeezes for at least 2 s. Each patient completes two attempts with each hand, with the arm fully extended, forming an angle of 30- with respect to the trunk. The maximum score in kilograms for each hand is recorded.
Measured: change from upper body muscular strength at at 1, 3, 6 and 12 months after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start4 Oct 2021
- Primary completion31 May 2024
- Study completionDec 2025 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719493
- Sponsor's protocol ID
- SLT/21/000009
- Acronym
- SYNCHRONIZE +
- Status last verified
- Dec 2024
- First submitted
- 30 Jan 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Primary Care Intervention in Fibromyalgia and Chronic Fatigue Syndrome: SYNCHRONIZE + Mixed Methods Study Protocol.
- ClinicalTrials.gov ID
- NCT05719493
- Acronym / sponsor ID
- SYNCHRONIZE + / SLT/21/000009
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Keywords
- multicomponent intervention, nutrition, chronobiology, physical exercise, quality of life, primary health care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Feb 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.
Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.
Detailed description
The investigators will perform a mixed study through a randomized clinical trial in Catalonian Primary Care with patients diagnosed of Fibromyalgia (M79.7) or both Fibromyalgia and Chronic Fatigue Syndrome (G93.3). The control group will follow the usual clinical practice and the intervention group, the usual practice plus the studied intervention (12 hours in 4 days). The intervention (based on nutrition, chronobiology and physical exercise) will be designed taking into account participant's opinion through focus groups. In both groups, quality of life (EuroQol-5D), as well as MFI, VAS pain, PSQI, erMEDAS-17, BRIAN, REGICOR-Short, FIQR and HADs questionnaires will be collected, prior to the intervention, and 1, 3, 6 and 12 months post-intervention. Food intake, body composition, resistance and strength will also be evaluated. The effect size will be calculated using Cohen's d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. In addition, a qualitative analysis with a descriptive phenomenological perspective from post-intervention focus groups of participants and professionals will be done.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multicomponent-treatment no benefiting group | No intervention | –Participants in the control group will receive the care from the usual clinical practice |
| munticomponent-treatment benefiting group | Experimental | Other: multicomponent treatmentPartcipants in the intervention group will receive the care from the usual practice plus the studied intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People aged 18-65, recent diagnosis of Fibromyalgia (M79.1) (<10 years), or diagnosis of Fibromyalgia and Chronic Fatigue Syndrome (M79 .7 and G93.3), with availability, motivation and interest in the intervention.
Key exclusion criteria (1 listed)
- not meeting the inclusion criteria, being participating in other group interventions aimed at the treatment of these syndromes, presence of severe mental comorbidity or other relevant medical disorders or pathologies that may interfere with the evaluation of the intervention
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 |
|---|---|---|
| multicomponent treatmentThe intervention to be evaluated consists of 4 group sessions carried out in two weeks, 6 hours per week divided in 2 days (a total of 12 hours), of active education in nutrition, chronobiology and physical exercise in people diagnosed with Chronic Fatigue Syndrome and Fibromyalgia. | Other | munticomponent-treatment benefiting group |
Primary outcome
change in quality of life
Time frame: change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention
to be evaluated with the EuroQol-5D questionnaire. It will be measured by a scale Likert: 0 (worst health) to 100 (better health) and a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; with five levels of severity in each dimension: no problems, mild problems, moderate problems, severe problems, and extreme problems/impossibility.
15 secondary outcomes
change in fatigue indicator
Time frame: change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention
change in sleep quality and insomnia indicator
Time frame: change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention
change in pain indicator
Time frame: change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention
change in adherence to the Mediterranean diet
Time frame: change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention
change in physical exercise practice and sedentary lifestyle
Time frame: change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention
change in circadian biological rhythm
Time frame: change from circadian biological rhythm at 1, 3, 6 and 12 months after the beginning of the intervention
change in functional impact of fibromyalgia
Time frame: change from functional impact of fibromyalgia at 1, 3, 6 and 12 months after the beginning of the intervention
change in mood indicator (anxiety)
Time frame: change from mood indicator (anxiety) at 1, 3, 6 and 12 months after the beginning of the intervention
change in food intake
Time frame: change from food intake at at 1, 3, 6 and 12 months after the beginning of the intervention
change in body mass index (BMI)
Time frame: change from BMI at 1, 3, 6 and 12 months after the beginning of the intervention
change in body fat
Time frame: change from body fat at 1, 3, 6 and 12 months after the beginning of the intervention
change in skeletal muscle
Time frame: change from skeletal muscle at 1, 3, 6 and 12 months after the beginning of the intervention
change in endurance
Time frame: change from endurance at 1, 3, 6 and 12 months after the beginning of the intervention
change in lower body muscular strength
Time frame: change from lower body muscular strength at 1, 3, 6 and 12 months after the beginning of the intervention
change in upper body muscular strength
Time frame: change from upper body muscular strength at at 1, 3, 6 and 12 months after the beginning of the intervention
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 18 Dec 2024.
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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.
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?
A study testing multicomponent treatment in people with Fibromyalgia and Chronic Fatigue Syndrome, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. 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?
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?
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?
change in quality of life (time frame: change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention). 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 18 Dec 2024.