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Open Access Study protocol

Land- and water-based exercise intervention in women with fibromyalgia: the al-andalus physical activity randomised controlled trial

Ana Carbonell-Baeza12*, Jonatan R Ruiz13, Virginia A Aparicio14, Francisco B Ortega34, Diego Munguía-Izquierdo5, Inmaculada C Álvarez-Gallardo1, Víctor Segura-Jiménez1, Daniel Camiletti-Moirón14, Alejandro Romero1, Fernando Estévez-López1, Blanca Samos1, Antonio J Casimiro6, Ángela Sierra7, Pedro A Latorre8, Manuel Pulido-Martos9, Pedro Femia10, Isaac J Pérez-López1, Palma Chillón1, María J Girela-Rejón1, Pablo Tercedor1, Alejandro Lucía11 and Manuel Delgado-Fernández1*

Author Affiliations

1 Department of Physical Education and Sport, School of Sport Sciences, University of Granada, Granada, Spain

2 Department of Physical Education, School of Education, University of Cadiz, Cadiz, Spain

3 Department of Biosciences and Nutrition at NOVUM, Unit for Preventive Nutrition, Karolinska Institutet, Huddinge, Sweden

4 Department of Physiology, School of Pharmacy, University of Granada, Granada, Spain

5 Deparment of Physical Education and Sports, University Pablo de Olavide, Seville, Spain

6 Department of Didactics for Language and Literature, Social Science and Physical and Sports Education, University of Almeria, Almeria, Spain

7 Department of Physical Education, Music and Arts, University of Huelva, Huelva, Spain

8 Department of Didactics of Music, Plastic and Corporal Expression, University of Jaen, Jaen, Spain

9 Department of Psychology, University of Jaen, Jaen, Spain

10 Biostatistics, School of Medicine, University of Granada, Granada, Spain

11 Department of Biomedicine, European University of Madrid, Madrid, Spain

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BMC Musculoskeletal Disorders 2012, 13:18  doi:10.1186/1471-2474-13-18

Published: 15 February 2012

Abstract

Background

The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome), and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes) in women with fibromyalgia.

Methods/Design

One hundred eighty women with fibromyalgia (age range: 35-65 years) will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain). Patients will be randomly assigned to a usual care (control) group (n = 60), a water-based exercise intervention group (n = 60) or a land-based exercise intervention group (n = 60). Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each) per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention) on the studied variables.

Discussion

Our study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia.

Trial registration

ClinicalTrials.gov ID: NCT01490281