Fibromyalgia Clinical Trial
Official title:
Land- and Water-Based Exercise Intervention in Women With Fibromyalgia: The Al-Andalus Physical Activity Randomised Control Trial
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 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 minutes each) per week during 24 weeks. Both exercise interventions will
consist of aerobic, muscular strength and flexibility exercises.
Discussion The investigators 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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