Strengthening Exercises for Fibromyalgia

NCT02063750 | Completed Phase 4

• 1 other identifier: CEP/UNIFESP - 1785/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: We evaluated the effectiveness of strengthening exercises using the Swiss ball in patients with fibromyalgia (FM). Material and Method: Sixty FM patients were randomized into two groups: an intervention group (IG), in which patients performed muscle strength exercises using the Swiss ball, and a stretching group (SG), in which patients performed stretching exercises. All patients participated in 40-minute training sessions three times per week for 12 weeks. The IG performed the following eight strengthening exercises using a Swiss ball: lateral rise, simultaneous biceps curl, squat, two arms triceps extension, abdominal, one arm dumbbell row, reverse crucifix and crucifix. The SG performed exercises targeting the same muscle groups trained in IG. Outcome measures were as follows: visual analogue scale (VAS) for pain, 1 repetition maximum test for muscle strength; fibromyalgia impact questionnaire (FIQ) to evaluate disease impact, and short form health survey (SF-36) to assess quality of life. All participants underwent an evaluation at baseline, at 6 weeks and at 12 weeks of training. The assessor was blind to patient allocation.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Muscle strength exercises; Pain; Quality of life

Outcome Measures

Primary Outcomes (1)

• Changes in Pain - VAS

  Basline, after 6 and 12 weeks

Secondary Outcomes (3)

• Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire

  Baseline, after 6 and 12 weeks

• Changes in muscle strength using the maximum repetition (1 RM)

  Baseline, after 6 and 12 weeks

• Changes in consumption of analgesics

  After 6 and 12 weeks from baseline

Study Arms (2)

Strengthening group

EXPERIMENTAL

This group perform muscle strengthening exercises using a Swiss ball of 65 cm diameter.

Other: strengthening exercises using a Swiss ball

Stretching group

ACTIVE COMPARATOR

Performed stretching exercises

Other: strengthening exercises

Interventions

strengthening exercises using a Swiss ball OTHER

This group performed eight muscle strengthening exercises using a Swiss ball of 65 cm diameter and dumbbells with different loads. Each training session was 40 minutes long and was performed three times a week for 12 weeks. The exercises were performed in three sets of 12 repetitions, with an interval of one to two minutes of recovery between exercises, which alternated between upper limbs, lower limbs and abdomen. The load used was 60 % of one repetition maximum (1RM).

Strengthening group

strengthening exercises OTHER

The stretching group performed stretching exercises that targeted the same muscles trained in the IG. The participants remained in the stretched position for three sets of 30 s for each exercise. The total session time was 40 minutes.

Stretching group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female with fibromyalgia according to the classification criteria of the American College of Rheumatology;
• aged between 20 and 65 years old.

You may not qualify if:

• uncontrolled hypertension;
• decompensated cardiac disease;
• history of syncope or exercise-induced arrhythmias and decompensated diabetes;
• severe psychiatric illness;
• history of regular exercise at least twice a week for the last 6 months;
• any other condition that could prevent the patient from performing physical exercises.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-090, Brazil

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rheumatology Division

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

BR (1)