Strengthening Exercises for Fibromyalgia

Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: strengthening exercises using a Swiss ball; Other: strengthening exercises

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023-090
      • Universidade Federal de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Strengthening group; This group perform muscle strengthening exercises using a Swiss ball of 65 cm diameter.	Other: strengthening exercises using a Swiss ball; 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).
ACTIVE_COMPARATOR: Stretching group; Performed stretching exercises	Other: strengthening exercises; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Pain - VAS	Basline, after 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (ESTIMATE): February 14, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2014
• Last Update Submitted That Met QC Criteria: February 13, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Fibromyalgia; Muscle strength exercises
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: CEP/UNIFESP - 1785/11