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Effects of Therapeutic Exercise in Patients With Fibromyalgia

Effects of Therapeutic Exercise in Patients With Fibromyalgia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04817605
Enrollment
30
Registered
2021-03-26
Start date
2021-03-10
Completion date
2022-06-20
Last updated
2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Therapeutic Exercise

Brief summary

Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients. The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers. For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR). Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks. The variables are measured at the beginning and end of treatment.

Interventions

OTHERTherapeutic Exercise

Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Sponsors

Universidad de Zaragoza
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed medically with Fibromyalgia * Diagnosed according to the American College of Rheumatology criteria * Agreement to attend to treatment sessions

Exclusion criteria

* Any kind of contraindications for physical activity * Other kind of diseases that could limit the intervention * Previous surgery last year * Medication modifications in the last 3 months

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityBaselineVAS
Quality of SleepBaselineThe investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline

Secondary

MeasureTime frameDescription
Analysis of tryptophan metabolitesBaselineThe investigators measure the tryptophan metabolites with blood test analysis at baseline
Pressure pain thresholdBaselineThe investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline
Central sensitizationBaselineThe investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026