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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

Spain1 site
  • Institut Català de la Salut

    Tortosa, Tarragona, 43500

Other trials in Spain

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.

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 groups in NCT05719493
Study groupRoleWhat they receive
multicomponent-treatment no benefiting groupNo interventionParticipants in the control group will receive the care from the usual clinical practice
munticomponent-treatment benefiting groupExperimentalPartcipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  1. First posted9 Feb 2023
  2. Study start4 Oct 2021
  3. Primary completion31 May 2024
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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