Effects of Therapeutic Exercise in Patients With Fibromyalgia
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2021
CompletedFirst Submitted
Initial submission to the registry
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedMay 18, 2023
May 1, 2023
1.3 years
March 23, 2021
May 16, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Pain intensity
VAS
Baseline
Pain intensity
VAS
through study completion, an average 10 weeks
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Baseline
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
through study completion, an average 10 weeks
Secondary Outcomes (6)
Pressure pain threshold
Baseline
Pressure pain threshold
through study completion, an average 10 weeks
Central sensitization
Baseline
Central sensitization
through study completion, an average 10 weeks
Analysis of tryptophan metabolites
Baseline
- +1 more secondary outcomes
Study Arms (1)
Exercise Therapy
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed medically with Fibromyalgia
- Diagnosed according to the American College of Rheumatology criteria
- Agreement to attend to treatment sessions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sandra Jiménez Jiménez-del-Barrio
Soria, 42004, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University of Valladolid Faculty of Health Sciences
Study Record Dates
First Submitted
March 23, 2021
First Posted
March 26, 2021
Study Start
March 10, 2021
Primary Completion
June 10, 2022
Study Completion
June 20, 2022
Last Updated
May 18, 2023
Record last verified: 2023-05