Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 2:04 PM
Study NCT ID:
NCT05719493
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2023-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)
Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Study Overview
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.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SYNCHRONIZE +
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: