Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

NCT ID: NCT04031391

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-22
• Study Completion Date: 2018-12-15

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

physical activity group

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

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

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Catala de Salut

OTHER_GOV

Sponsor Role: collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JACOBO MENDIOROZ PEÑA, MD

Role: STUDY_CHAIR

Institut Catala de Salut

Locations

Espai Civic Centre

Igualada, Barcelona, Spain

Countries

Spain

Other Identifiers

7Z17/032

Identifier Type: -

Identifier Source: org_study_id