FibromyalgiaPhase 2NCT01490281

Exercise in Women With Fibromyalgia

A Phase 2 study testing water-based exercise and land-based exercise intervention in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 65 years, women only
Conditions the study is for: Fibromyalgia
What is being tested?: water-based exercise and land-based exercise intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteSpain
Study dates: Nov 2011to Dec 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of Granada
Granada, Granada, 18011

Other trials in Spain

About this study

Official title: 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.

Conditions: Fibromyalgia
Being tested: water-based exercise, land-based exercise intervention
Keywords: Fibromyalgia, exercise, physical activity, pain
Medical subject headings: Fibromyalgia, Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

water-based exerciseBehavioural
Interventions will consist of aerobic, muscular strength and flexibility exercises in the water
land-based exercise interventionBehavioural
Interventions will consist of aerobic, muscular strength and flexibility exercises in the land

Study groups in NCT01490281
Study group	Role	What they receive
water-based exercise intervention	Experimental	Not described Receives: Behavioral: water-based exercise
land-based exercise intervention	Experimental	Not described Receives: Behavioral: land-based exercise intervention
Control group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Participants will be followed over 24 weeks

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: Participants will be followed over 24 weeks
Sleep Quality
Pittsburgh Sleep Quality Index will be used to assess sleep quality and disturbances
Measured: 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)
Measured: 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
Measured: Participants will be followed over 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Dec 2014

First posted12 Dec 2011 (estimated)
Study startNov 2011
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01490281
Sponsor's protocol ID: DEP2010-15639
Other IDs: CTCD-201000019242-TRA
Status last verified: Jan 2015
First submitted: 5 Dec 2011
Last updated: 8 Jan 2015
Results posted: No
Data monitoring committee: Yes

Publications

Alvarez-Gallardo IC, Gavilan-Carrera B, Carbonell-Baeza A, Segura-Jimenez V, Camiletti-Moiron D, Borges-Cosic M, Aparicio V, Delgado-Fernandez M. Land- and water-based supervised exercise intervention for women with fibromyalgia: a CERT-based protocol from the al-Andalus randomized controlled trial. Contemp Clin Trials. 2026 Oct 4:108487. doi: 10.1016/j.cct.2026.108487. Online ahead of print.
PubMed 42830128
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.
PubMed 22336292

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Land- and Water-Based Exercise Intervention in Women With Fibromyalgia: The Al-Andalus Physical Activity Randomised Control Trial
ClinicalTrials.gov ID: NCT01490281
Acronym / sponsor ID: DEP2010-15639
Conditions: Fibromyalgia
Keywords: Fibromyalgia, exercise, physical activity, pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Universidad de GranadaUniversity, hospital or other
Study start: Nov 2011
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 12 Dec 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
water-based exercise intervention	Experimental	Behavioral: water-based exercise
land-based exercise intervention	Experimental	Behavioral: land-based exercise intervention
Control group	No intervention	–

Who may qualify

Ages: 35 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
water-based exerciseInterventions will consist of aerobic, muscular strength and flexibility exercises in the water	Behavioural	water-based exercise intervention
land-based exercise interventionInterventions will consist of aerobic, muscular strength and flexibility exercises in the land	Behavioural	land-based exercise intervention

Primary outcome

Overall impact of fibromyalgia
Time frame: Participants will be followed over 24 weeks
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.

9 secondary outcomes

Tenderness
Time frame: Participants will be followed over 24 weeks
Visual analogic scale for pain
Time frame: Participants will be followed over 24 weeks
The Pain Catastrophizing Scale
Time frame: Participants will be followed over 24 weeks
Body composition
Time frame: Participants will be followed over 24 weeks
Functional capacity
Time frame: Participants will be followed over 24 weeks
Fatigue
Time frame: Participants will be followed over 24 weeks
Sleep Quality
Time frame: Participants will be followed over 24 weeks
Health-related quality of life
Time frame: Participants will be followed over 24 weeks
Cognitive function
Time frame: Participants will be followed over 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
Derived from this study: PubMed 42830128Alvarez-Gallardo IC, Gavilan-Carrera B, Carbonell-Baeza A, Segura-Jimenez V, Camiletti-Moiron D, Borges-Cosic M, Aparicio V, Delgado-Fernandez M. Land- and water-based supervised exercise intervention for women with fibromyalgia: a CERT-based protocol from the al-Andalus randomized controlled trial. Contemp Clin Trials. 2026 Oct 4:108487. doi: 10.1016/j.cct.2026.108487. Online ahead of print.
Derived from this study: PubMed 22336292Carbonell-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.

Related trials for Fibromyalgia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing water-based exercise and land-based exercise intervention in people with Fibromyalgia, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall impact of fibromyalgia (time frame: Participants will be followed over 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01490281, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015; AzTrials last refreshed its copy on 5 Nov 2026.