Strengthening Exercises for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063750
• Other study ID #: CEP/UNIFESP - 1785/11
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2014
• Last updated: February 13, 2014
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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).
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Pain - VAS		Basline, after 6 and 12 weeks	No
Secondary	Changes in quality of life - Fibromyalgia Impact Questionnaire (FIQ) questionnaire		Baseline, after 6 and 12 weeks	No
Secondary	Changes in muscle strength using the maximum repetition (1 RM)		Baseline, after 6 and 12 weeks	No
Secondary	Changes in consumption of analgesics		After 6 and 12 weeks from baseline	No