Exercise in Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Land- and Water-Based Exercise Intervention in Women With Fibromyalgia: The Al-Andalus Physical Activity Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490281
• Other study ID #: DEP2010-15639
• Secondary ID: CTCD-20100001924
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2011
• Last updated: January 7, 2015
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• water-based exercise
Interventions will consist of aerobic, muscular strength and flexibility exercises in the water
• land-based exercise intervention
Interventions will consist of aerobic, muscular strength and flexibility exercises in the land

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index will be used to assess sleep quality and disturbances	Participants will be followed over 24 weeks	No
Secondary	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	No
Secondary	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	No