Exercise in Women With Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Universidad de Granada.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jonatan Ruiz Ruiz, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT01490281
First received: December 5, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Behavioral: water-based exercise
Behavioral: land-based exercise intervention
Behavioral: Control group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Land- and Water-Based Exercise Intervention in Women With Fibromyalgia: The Al-Andalus Physical Activity Randomised Control Trial

Resource links provided by NLM:


Further study details as provided by Universidad de Granada:

Primary Outcome Measures:
  • Overall impact of fibromyalgia [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Tenderness [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Visual analogic scale for pain [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    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.

  • The Pain Catastrophizing Scale [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Body composition [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    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).

  • Functional capacity [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    Participants' functional capacity will be assessed by field-based fitness tests following the standardised Functional Senior Fitness Test Battery

  • Fatigue [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Sleep Quality [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index will be used to assess sleep quality and disturbances

  • Health-related quality of life [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    We will determine patients' quality of life with the Short-Form Health Survey 36 (SF-36)

  • Cognitive function [ Time Frame: Participants will be followed over 24 weeks ] [ Designated as safety issue: No ]
    The Mini Mental State Examination (MMSE) will be used to evaluate cognitive capacity and severity of dementia for the exclusion criteria


Estimated Enrollment: 180
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: Control group Behavioral: Control group
General physical activity guidelines

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490281

Contacts
Contact: Manuel Delgado, PhD 003495824473 manueldf@ugr.es

Locations
Spain
University of Granada Recruiting
Granada, Spain, 18011
Contact: Manuel Delgado    0034244373      
Principal Investigator: Manuel Delgado, PhD         
Sub-Investigator: Ana Carbonell, PhD         
Sub-Investigator: Jonatan R Ruiz, PhD         
Sponsors and Collaborators
Universidad de Granada
  More Information

No publications provided by Universidad de Granada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonatan Ruiz Ruiz, Co-Coordinator, Junior Research Fellow, Universidad de Granada
ClinicalTrials.gov Identifier: NCT01490281     History of Changes
Other Study ID Numbers: DEP2010-15639, CTCD-201000019242-TRA
Study First Received: December 5, 2011
Last Updated: December 9, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Universidad de Granada:
Fibromyalgia
exercise
physical activity
pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014