Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

NCT04031391 | Completed

• 1 other identifier: 7Z17/032
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

physical activity; fibromyalgia; pain; exercice; quality of live

Outcome Measures

Primary Outcomes (3)

• The visual analogue scale (VAS)

  evaluate pain, with a score of 0 to 10

  two months

• 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

• 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

Study Arms (2)

physical activity group

EXPERIMENTAL

Other: Physical activity

Control group

NO INTERVENTION

Interventions

Physical activity 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

physical activity group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• Ages of 40 and 75
• Diagnosis fibromyalgia (code M79.7)
• Anoia region

You may not qualify if:

• Pregnant
• Unable to participate in the physical activity program.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Catala de Salut: collaborator

Study Sites (1)

Espai Civic Centre

Igualada, Barcelona, 08700, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• JACOBO MENDIOROZ PEÑA, MD

  Institut Catala de Salut

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, multi-center, clinical trial composed of two groups response variables and a twelve weeks follow up.

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 24, 2019
• Study Start: July 22, 2017
• Primary Completion: August 30, 2017
• Study Completion: December 15, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)