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Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +) (SYNCHRONIZE +)

Primary Purpose

Fibromyalgia, Chronic Fatigue Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
multicomponent treatment
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fibromyalgia focused on measuring multicomponent intervention, nutrition, chronobiology, physical exercise, quality of life, primary health care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Institut Català de la SalutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

multicomponent-treatment no benefiting group

munticomponent-treatment benefiting group

Arm Description

Participants in the control group will receive the care from the usual clinical practice

Partcipants in the intervention group will receive the care from the usual practice plus the studied intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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).
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).
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.
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).
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)
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.
change in body mass index (BMI)
Weight and height will be combined to report BMI in Kg/m2.
change in body fat
Body fat (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.
change in skeletal muscle
Skeletal muscle (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.
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 .
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.
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.

Full Information

First Posted
January 30, 2023
Last Updated
February 8, 2023
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Català de la Salut, Department of Health, Generalitat de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05719493
Brief Title
Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)
Acronym
SYNCHRONIZE +
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Català de la Salut, Department of Health, Generalitat de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Fatigue Syndrome
Keywords
multicomponent intervention, nutrition, chronobiology, physical exercise, quality of life, primary health care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multicomponent-treatment no benefiting group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive the care from the usual clinical practice
Arm Title
munticomponent-treatment benefiting group
Arm Type
Experimental
Arm Description
Partcipants in the intervention group will receive the care from the usual practice plus the studied intervention.
Intervention Type
Other
Intervention Name(s)
multicomponent treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in quality of life
Description
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.
Time Frame
change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention
Secondary Outcome Measure Information:
Title
change in fatigue indicator
Description
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.
Time Frame
change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in sleep quality and insomnia indicator
Description
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.
Time Frame
change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in pain indicator
Description
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).
Time Frame
change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in adherence to the Mediterranean diet
Description
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).
Time Frame
change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in physical exercise practice and sedentary lifestyle
Description
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).
Time Frame
change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in circadian biological rhythm
Description
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.
Time Frame
change from circadian biological rhythm at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in functional impact of fibromyalgia
Description
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).
Time Frame
change from functional impact of fibromyalgia at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in mood indicator (anxiety)
Description
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)
Time Frame
change from mood indicator (anxiety) at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in food intake
Description
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.
Time Frame
change from food intake at at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in body mass index (BMI)
Description
Weight and height will be combined to report BMI in Kg/m2.
Time Frame
change from BMI at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in body fat
Description
Body fat (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.
Time Frame
change from body fat at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in skeletal muscle
Description
Skeletal muscle (measured in %) will be measured by bioimpedance with a OMRON BF511 body composition monitor.
Time Frame
change from skeletal muscle at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in endurance
Description
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 .
Time Frame
change from endurance at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in lower body muscular strength
Description
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.
Time Frame
change from lower body muscular strength at 1, 3, 6 and 12 months after the beginning of the intervention
Title
change in upper body muscular strength
Description
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.
Time Frame
change from upper body muscular strength at at 1, 3, 6 and 12 months after the beginning of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere M Zaragoza, BSc
Phone
+34 934824253
Email
pmonteagudo@idiapjgol.org
First Name & Middle Initial & Last Name or Official Title & Degree
Noèlia Carrasco-Querol, PhD
Phone
+34 977588911
Email
ncarrasco@idiapjgol.info
Facility Information:
Facility Name
Institut Català de la Salut
City
Tortosa
State/Province
Tarragona
ZIP/Postal Code
43500
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noèlia Carrasco-Querol, PhD
Phone
+34 977588911
Email
ncarrasco@idiapjgol.info
First Name & Middle Initial & Last Name & Degree
Noèlia Carrasco-Querol, PhD
First Name & Middle Initial & Last Name & Degree
Gemma González Serra
First Name & Middle Initial & Last Name & Degree
Alessandra Q. Gonçalves, PhD
First Name & Middle Initial & Last Name & Degree
Nerea Bueno Hernández
First Name & Middle Initial & Last Name & Degree
Marta Pastor Cazalla
First Name & Middle Initial & Last Name & Degree
Pau Bestratén del Pino
First Name & Middle Initial & Last Name & Degree
Pilar Montesó Curto, PhD
First Name & Middle Initial & Last Name & Degree
Rosa Caballol Angelats
First Name & Middle Initial & Last Name & Degree
Inmaculada Fusté Anguera
First Name & Middle Initial & Last Name & Degree
Elisabet Castro Blanco
First Name & Middle Initial & Last Name & Degree
José Fernández-Sáez, PhD
First Name & Middle Initial & Last Name & Degree
Maria Rosa Dalmau Llorca, PhD
First Name & Middle Initial & Last Name & Degree
Carina Aguilar Martín, PhD
First Name & Middle Initial & Last Name & Degree
Anna Vila Martí, PhD

12. IPD Sharing Statement

Learn more about this trial

Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)

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