Please select the eligibility criteria that correspond to the clinical trial below.
Title: Land- and Water-Based Exercise Intervention in Women With Fibromyalgia: The Al-Andalus Physical Activity Randomised Control Trial
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.


Options:
A: Inclusion Criteria:

* Meets American College of Rheumatology (ACR) criteria for FM
* Inactive at study entry
* Willing to become more physically active
* Understands and willing to follow study recommendations regarding lifestyle modification
* Able to participate in the study for 2 years
* Agrees to not make any changes to current FM-related treatments

Exclusion Criteria:

* Any comorbidity that may worsen a participant's physical functioning, independent of FM (e.g., significant cardiovascular disease, history of arrhythmias, morbid obesity, autoimmune diseases, uncontrolled or untreated hypertension, significant renal or prostate disease, stroke, seizure disorder, any other significant neurological diseases)
* Significant peripheral neuropathy
* Any current psychiatric disorder that involves a history of psychosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar disorder, or severe personality disorder. Participants with mood disorder are not excluded.
* Alcohol or substance abuse within the 2 years prior to study entry
* Current suicide risk or suicide attempt within the 2 years prior to study entry
* Severe physical disability that may interfere with physical activity
* Currently participates in structured exercise or plans to participate in an exercise program
* Any investigational medications or devices within 4 weeks prior to study entry
* Any expected life change, such as relocation, within the next 2 years that may prevent study participation
B: Inclusion Criteria:

- Established diagnosis of fibromyalgia, age \> 18 years. Exclusion Criteria: cardiac, pulmonary or orthopedic condition that would limit exercise.

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C: 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.
D: Inclusion Criteria:

* Age greater than or equal to 18 years
* A diagnosis of fibromyalgia according to American College of Rheumatology criteria
* Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity
* Pain medications must have been stable for at least 14 days.
* Ability to follow the protocol (with reference to cognitive and situational conditions, (e.g. stable housing, ability to attend follow-up visits, motivation and commitment to self practice of CFQ Qigong for 45-60 minutes per day).
* Willing and able to give written informed consent

Exclusion Criteria:

* Presence of clinically significant medical disorder on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician
* Already practicing CFQ Qigong on a regular basis
* Unable to commit to 45-60 minutes of CFQ Qigong practice per day

Answer: C