Supervised land- and water-based exercis intervention in women with fibromyalgia: CERT- based exercise study protocol of the al-Andalus physical activity randomised controlled trial

Abstract

Background: Exercise is recommended for managing fibromyalgia; however, the scant details provided about exercise programs (EP) in the available literature make standardization, replicability, and interpretation of results difficult. The aim of the present report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the land- and water-based EP implemented in the al-Andalus Randomized Controlled Trial (RCT). Methods: Women aged 35-65 with fibromyalgia (n=180) were planned to be recruited in Southern Spain (Andalucia). The study design was composed of three groups: the usual care (control) group, the land- and the water-based supervised exercise intervention groups (n=60 for each group). Participants allocated in the exercise intervention groups undertook a 24-week supervised multicomponent (strength, aerobic and flexibility) EP (three non-consecutive sessions per week, 45-60 min/session). The rationale of the exercise program is described in detail following the CERT criteria detailing its 16 key items. Discussion: This study details the supervised EP of the al-Andalus RCT project, which may serve: 1) exercise professionals who would like to implement an evidence-based supervised EP for people with fibromyalgia in land- and water-based settings, and 2) as an example of the application of the CERT criteria.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This project was funded by the Spanish Ministry of Science and Innovation [I+D+i DEP2010-15639]. ICAG was supported by the Spanish Ministry of Economy and Competitiveness [BES-2011-047133]. BGC was supported by the Spanish Ministry of Education [FPU15/00002] and the Spanish Ministry of Universities Next Generation Margarita Salas Grant Program. VSJ was supported by the Spanish Ministry of Education [AP-2010-0963]. MBC was supported by the Spanish Ministry of Education [FPU14/02518].

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Medical Ethics Committee of Hospital Virgen de las Nieves (Granada, Spain) gave ethical approval for this work

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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