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Effects of Therapeutic Exercise in Patients With Fibromyalgia

Primary Purpose

Therapeutic Exercise, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic Exercise
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Therapeutic Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sandra Jiménez Jiménez-del-Barrio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Therapy

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity
VAS
Pain intensity
VAS
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2021
Last Updated
May 16, 2023
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04817605
Brief Title
Effects of Therapeutic Exercise in Patients With Fibromyalgia
Official Title
Effects of Therapeutic Exercise in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutic Exercise, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
VAS
Time Frame
Baseline
Title
Pain intensity
Description
VAS
Time Frame
through study completion, an average 10 weeks
Title
Quality of Sleep
Description
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Time Frame
Baseline
Title
Quality of Sleep
Description
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Time Frame
through study completion, an average 10 weeks
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline
Time Frame
Baseline
Title
Pressure pain threshold
Description
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment
Time Frame
through study completion, an average 10 weeks
Title
Central sensitization
Description
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline
Time Frame
Baseline
Title
Central sensitization
Description
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS)
Time Frame
through study completion, an average 10 weeks
Title
Analysis of tryptophan metabolites
Description
The investigators measure the tryptophan metabolites with blood test analysis at baseline
Time Frame
Baseline
Title
Analysis of tryptophan metabolites
Description
The investigators measure the tryptophan metabolites with blood test analysis at baseline
Time Frame
through study completion, an average 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sandra Jiménez Jiménez-del-Barrio
City
Soria
ZIP/Postal Code
42004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Therapeutic Exercise in Patients With Fibromyalgia

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