Exercise in Women With Fibromyalgia

NCT01490281 | Completed Phase 2 DMC

• 2 other identifiers: DEP2010-15639CTCD-201000019242-TRA
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; exercise; physical activity; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Tenderness

  Participants will be followed over 24 weeks

• Visual analogic scale for pain

  Participants will be followed over 24 weeks

• The Pain Catastrophizing Scale

  Participants will be followed over 24 weeks

• Body composition

  Participants will be followed over 24 weeks

• Functional capacity

  Participants will be followed over 24 weeks

Study Arms (3)

water-based exercise intervention

EXPERIMENTAL

Behavioral: water-based exercise

land-based exercise intervention

EXPERIMENTAL

Behavioral: land-based exercise intervention

Control group

NO INTERVENTION

Interventions

water-based exercise BEHAVIORAL

Interventions will consist of aerobic, muscular strength and flexibility exercises in the water

water-based exercise intervention

land-based exercise intervention BEHAVIORAL

Interventions will consist of aerobic, muscular strength and flexibility exercises in the land

land-based exercise intervention

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, Granada, 18011, Spain

Location

Related Publications (1)

• 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.

  PMID: 22336292 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Coordinator, Junior Research Fellow

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 12, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

ES (1)