A Functional Exercise Program Improves Pain and Health Related Quality of Life in Patients With Fibromyalgia

NCT03682588 | Completed DMC

• 1 other identifier: 719.779
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is a syndrome characterized mainly by chronic generalized pain that affects the physical fitness and functional capacity of patients. There is increasing evidence of the benefits of physical exercise in improving fibromyalgia symptoms, making these interventions part of therapeutic arsenal. Objective: To evaluate the effectiveness of a program of functional exercises in reducing pain, improving functional capacity, increasing muscle strength, improving flexibility, balance and quality of life of patients with fibromyalgia. Intervention: The intervention group performed functional physical training for 45 minutes twice a week for 14 weeks. The control group will perform stretching exercises with the same duration and frequency. evaluation instruments: Visual Analog Scale for pain; Fibromyalgia Impact Questionnaire; Time-up and go test; 1Repetitian Maximum test; Sit and reach test; Berg Balance Scale; and Short Form-36 and amount of analgesics used during the intervention period was evaluated.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Exercise; Functional training

Outcome Measures

Primary Outcomes (1)

• Change in pain

  Evaluated using the Visual Analogue Scale for pain. Scores ranges from 0 to 10 with higher values represent a worse pain.

  Baseline, after 7, 14, 26 and 38 weeks

Secondary Outcomes (7)

• Change in Muscular Strength

  Baseline, after 7, 14, 26 and 38 weeks

• Change in functional performance

  Baseline, after 7, 14, 26 and 38 weeks

• Change in balance

  Baseline, after 7, 14, 26 and 38 weeks

• Change in Flexibility

  Baseline, after 7, 14, 26 and 38 weeks

• Change in General quality of life

  Baseline, after 7, 14, 26 and 38 weeks

Study Arms (2)

Functional exercise group

EXPERIMENTAL

Functional exercise program with 14 exercises, two times/week, during 14 weeks. Two sets of 10 repetitions each, with 30 seconds interval.

Other: Physical activity

Stretching exercise group

ACTIVE COMPARATOR

Stretching exercise program with 17 exercises, two times/week, during 14 weeks and each movement was repeated by three times and held for 20 seconds each

Other: Physical activity

Interventions

Physical activity OTHER

The Functional exercise group performed functional exercise training for 45 minutes twice a week for 14 weeks. The Stretching exercise group performed stretching exercises with the same duration and frequency.

Also known as: Functional exercise group and Stretching exercise group

Functional exercise group; Stretching exercise group

Eligibility Criteria

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

You may qualify if:

• Female sex
• Classification of fibromyalgia based on the criteria of the American College of Rheumatology
• Age 18 to 65 years;
• Pain intensity between 4 and 8cm on a visual analog scale ranging from 0 to 10cm
• Stable medication for at least three months

You may not qualify if:

• Uncontrolled cardiorespiratory disease
• Health condition for which physical exercise was contraindicated
• Serious psychiatric disorder
• Uncontrolled diabetes mellitus
• Inflammatory rheumatic disease
• History of regular physical exercise (30min, 3 times a week) in the previous 3 months

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Rheumatology outpatient clinics of a university hospital;

São Paulo, São Paulo, CEP 04039-002, Brazil

Location

Related Publications (1)

• Fernandes G, Nery M, Meireles SM, Santos R, Natour J, Jennings F. A functional exercise program improves pain and health related quality of life in patients with fibromyalgia: a randomized controlled trial. Adv Rheumatol. 2024 Oct 24;64(1):81. doi: 10.1186/s42358-024-00422-7.

  PMID: 39449056 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jamil Natour, Professor

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomised electronically generated randomisation table. Secret allocation (sealed opaque envelopes).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: September 24, 2018
• Study Start: October 1, 2018
• Primary Completion: September 2, 2019
• Study Completion: January 6, 2020
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

BR (1)