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OpenTrials
Completed

NCT Number: NCT02063750

Strengthening Exercises for Fibromyalgia

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Universidade Federal de Sao Paulo

São Paulo, 04023-090, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Changes in Pain - VAS

    Time frame: Basline, after 6 and 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 14, 2014
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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