Exercise in Women With Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: water-based exercise; Behavioral: land-based exercise intervention

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18011
    • University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age: 35-65 years.
• Meeting the American College of Rheumatology criteria: widespread pain for more than 3 months, and pain with 4 kg/cm of pressure reported for 11 or more of 18 tender points.
• Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q ).
• Not to be engaged in regular physical activity >20 minutes on >3 days/week.
• Planning to stay in the same Association during the study.
• Able to ambulate, with or without assistance.
• Able to communicate.
• Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

• Acute or terminal illness.
• Myocardial infarction in the past 3 months.
• Not capable to ambulate.
• Unstable cardiovascular disease or other medical condition.
• Upper or lower extremity fracture in the past 3 months.
• Severe dementia (MMSE<10).
• Unwillingness to either complete the study requirements or to be randomised into control or training group.
• Presence of neuromuscular disease or drugs affecting neuromuscular function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group
EXPERIMENTAL: water-based exercise intervention	Behavioral: water-based exercise; Interventions will consist of aerobic, muscular strength and flexibility exercises in the water
EXPERIMENTAL: land-based exercise intervention	Behavioral: land-based exercise intervention; Interventions will consist of aerobic, muscular strength and flexibility exercises in the land

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall impact of fibromyalgia	The primary outcome will be assessed with the fibromyalgia Impact Questionnaire (FIQ). FIQ is a self-administered questionnaire, comprising 10 subscales of disabilities and symptoms (physical function, work missed day, job ability, feel good, pain, fatigue, sleep, stiffness, anxiety and depression) and has been validated for Spanish fibromyalgia patients. The total scores range from 0 to 100, with a higher score indicating greater effect of the condition on the person's life.	Participants will be followed over 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tenderness	A total of 18 tender points will be assessed according to the American College of Rheumatology criteria for classification of fibromyalgia using a standard pressure algometer (FPK 20; Effegi, Alfonsine, Italy). The tender point count, total count of positive tender points, will be recorded for each participant. The algometer score will be calculated as the sum of the minimum pain-pressure values obtained for each tender point.	Participants will be followed over 24 weeks
Visual analogic scale for pain	Visual analogic scale for pain. This is a simple assessment tool consisting of a 10 cm line with 0 on one end, representing no pain, and 10 on the other, representing the worst pain ever experienced, which a patient marks to indicate the severity of her pain in the present moment. This scale will also be administered before and after each session during the intervention, to assess the acute effect of exercise on pain.	Participants will be followed over 24 weeks
The Pain Catastrophizing Scale	It assesses three factors: rumination, magnification and helplessness associated to pain. It includes 13 items measured on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). Higher scores indicate a greater tendency to catastrophize pain symptoms.	Participants will be followed over 24 weeks
Body composition	Weight and height will be measured, body mass index [weight (kg)/height(m2)] will be calculated, and skeletal muscle mass, total body water and fat free mass will be estimated with bioelectrical impedance analysis (InBody R20; Biospace, Gateshead, UK).	Participants will be followed over 24 weeks
Functional capacity	Participants' functional capacity will be assessed by field-based fitness tests following the standardised Functional Senior Fitness Test Battery	Participants will be followed over 24 weeks
Fatigue	The Multidimensional Fatigue Inventory will be used to measure fatigue severity, and comprises five subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation.	Participants will be followed over 24 weeks
Sleep Quality	Pittsburgh Sleep Quality Index will be used to assess sleep quality and disturbances	Participants will be followed over 24 weeks
Health-related quality of life	We will determine patients' quality of life with the Short-Form Health Survey 36 (SF-36)	Participants will be followed over 24 weeks
Cognitive function	The Mini Mental State Examination (MMSE) will be used to evaluate cognitive capacity and severity of dementia for the exclusion criteria	Participants will be followed over 24 weeks

Collaborators and Investigators

• Sponsor: Universidad de Granada

Publications and helpful links

General Publications

• Carbonell-Baeza A, Ruiz JR, Aparicio VA, Ortega FB, Munguia-Izquierdo D, Alvarez-Gallardo IC, Segura-Jimenez V, Camiletti-Moiron D, Romero A, Estevez-Lopez F, Samos B, Casimiro AJ, Sierra A, Latorre PA, Pulido-Martos M, Femia P, Perez-Lopez IJ, Chillon P, Girela-Rejon MJ, Tercedor P, Lucia A, Delgado-Fernandez M. Land- and water-based exercise intervention in women with fibromyalgia: the al-Andalus physical activity randomised controlled trial. BMC Musculoskelet Disord. 2012 Feb 15;13:18. doi: 10.1186/1471-2474-13-18.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 5, 2011
• First Submitted That Met QC Criteria: December 9, 2011
• First Posted (ESTIMATE): December 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2015
• Last Update Submitted That Met QC Criteria: January 7, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: physical activity; pain; exercise; Fibromyalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: DEP2010-15639; CTCD-201000019242-TRA (OTHER_GRANT: CTCD-201000019242-TRA)