Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring physical activity, fibromyalgia, pain, exercice, quality of live
Eligibility Criteria
Inclusion Criteria:
Women
- Ages of 40 and 75
- Diagnosis fibromyalgia (code M79.7)
- Anoia region
Exclusion Criteria:
- Pregnant
- Unable to participate in the physical activity program.
Sites / Locations
- Espai Civic Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
physical activity group
Control group
Arm Description
Outcomes
Primary Outcome Measures
The visual analogue scale (VAS)
evaluate pain, with a score of 0 to 10
The Spanish version of the SF-36 questionnaire
used to assess their perceived state of health. It includes eight variables: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
the Fibromyalgia Impact Questionnaire (FIQ)
measures physical functioning, ability to undertake work and general well-being, with a score from 0 to 80.
Secondary Outcome Measures
Full Information
NCT ID
NCT04031391
First Posted
July 19, 2019
Last Updated
July 22, 2019
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Catala de Salut
1. Study Identification
Unique Protocol Identification Number
NCT04031391
Brief Title
Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia
Official Title
Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 22, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
December 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Catala de Salut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Physical activity has been used for a number of years in the treatment of fibromyalgia (FM). The main objective of this study is to compare the effects of physical activity on two groups of women diagnosed with fibromyalgia (FM) in terms of pain, quality of life and the impact of the condition on their daily lives. Methods: this was a randomized clinical trial to assess the effects of physical activity performed by subjects assigned to one of two groups on the scores of three questionnaires (the pain Visual Analogue Scale, the FIQ questionnaire and the SF-36 health questionnaire) administered before and after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
physical activity, fibromyalgia, pain, exercice, quality of live
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, multi-center, clinical trial composed of two groups response variables and a twelve weeks follow up.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physical activity group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
The intervention group: engaged in a therapeutic physical activity program involving low-intensity exercise, strength and balance work for 2 days a week over a 12-week period, with each session lasting 90 minutes. Both the intervention group and the control group separately completed the various baseline surveys which were part of the study. Once the intervention was over, they answered them again, also separately.
The classes were led by an experienced physiotherapist who followed the physical exercise guidelines established by the American College of Sports Medicine (ACSM), although the intensity of the exercises was adapted to the participants' tolerance levels
Primary Outcome Measure Information:
Title
The visual analogue scale (VAS)
Description
evaluate pain, with a score of 0 to 10
Time Frame
two months
Title
The Spanish version of the SF-36 questionnaire
Description
used to assess their perceived state of health. It includes eight variables: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
Time Frame
two months
Title
the Fibromyalgia Impact Questionnaire (FIQ)
Description
measures physical functioning, ability to undertake work and general well-being, with a score from 0 to 80.
Time Frame
two months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women
Ages of 40 and 75
Diagnosis fibromyalgia (code M79.7)
Anoia region
Exclusion Criteria:
Pregnant
Unable to participate in the physical activity program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JACOBO MENDIOROZ PEÑA, MD
Organizational Affiliation
Institut Catala de Salut
Official's Role
Study Chair
Facility Information:
Facility Name
Espai Civic Centre
City
Igualada
State/Province
Barcelona
ZIP/Postal Code
08700
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia
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