Strengthening Exercises for Fibromyalgia

NCT ID: NCT02063750

Last Updated: 2014-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Strengthening group

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

Group Type: EXPERIMENTAL

strengthening exercises using a Swiss ball

Intervention Type: 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).

Stretching group

Performed stretching exercises

Group Type: ACTIVE_COMPARATOR

strengthening exercises

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Jamil Natour

Head of Rheumatology Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CEP/UNIFESP - 1785/11

Identifier Type: -

Identifier Source: org_study_id