Strengthening Exercises for Fibromyalgia

• ClinicalTrials.gov Identifier: NCT02063750
• Recruitment Status: Completed
• First Posted: February 14, 2014
• Last Update Posted: February 14, 2014
• Sponsor: Federal University of São Paulo
• Information provided by (Responsible Party): Jamil Natour, Federal University of São Paulo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: strengthening exercises using a Swiss ball; Other: strengthening exercises	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Strengthening Exercises Using the Swiss Ball for Patients With Fibromyalgia: a Randomized Controlled Trial
• Study Start Date: January 2011
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Changes in Pain - VAS [ Time Frame: Basline, after 6 and 12 weeks ]

Secondary Outcome Measures :

1. Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire [ Time Frame: Baseline, after 6 and 12 weeks ]
2. Changes in muscle strength using the maximum repetition (1 RM) [ Time Frame: Baseline, after 6 and 12 weeks ]
3. Changes in consumption of analgesics [ Time Frame: After 6 and 12 weeks from baseline ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Universidade Federal de Sao Paulo

Sao Paulo, SP, Brazil, 04023-090

Sponsors and Collaborators

Federal University of São Paulo

More Information

• Responsible Party: Jamil Natour, Head of Rheumatology Division, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT02063750
• Other Study ID Numbers: CEP/UNIFESP - 1785/11
• First Posted: February 14, 2014
• Last Update Posted: February 14, 2014
• Last Verified: February 2014

Keywords provided by Jamil Natour, Federal University of São Paulo:

Fibromyalgia; Muscle strength exercises; Pain; Quality of life

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases