Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031391
• Other study ID #: 7Z17/032
• Status: Completed
• Phase: N/A
• Start date: July 22, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: July 2019
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 15, 2018
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Physical activity
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

Locations

Country	Name	City	State
Spain	Espai Civic Centre	Igualada	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Institut Catala de Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The visual analogue scale (VAS)	evaluate pain, with a score of 0 to 10	two months
Primary	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	two months
Primary	the Fibromyalgia Impact Questionnaire (FIQ)	measures physical functioning, ability to undertake work and general well-being, with a score from 0 to 80.	two months