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Completed

NCT Number: NCT03588208

Progressive Resistance Training for Fibromyalgia

Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
  • Feminine gender;
  • Age between 18 and 65 years;
  • Pain between 3 and 8 cm in the Numerical Pain Scale (END);
  • Have not changed treatment for fibromyalgia in the past three months;
  • Agree to participate in the study and sign the informed consent form.

Exclusion criteria

  • Cognitive deficit that does not allow the understanding of the evaluation instruments;
  • Other diseases that make it impossible to perform the exercises;
  • Physical activity started or changed in the last three months;
  • Physical therapy in the last six months;
  • In litigation.

Treatment and study plan

Progressive resistance training program

Other

Progressive resistance training program were performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training.

Educational program

Other

Structured education program were performed during one hour class once a week for five weeks

Primary outcomes

  1. Change in pain

    Time frame: Baseline and after 6 and 12 weeks

    Measured by numerical pain scale

Secondary outcomes

  1. Change in Health related quality of life

    Time frame: Baseline and after 6 and 12 weeks

    Measured by Fibromyalgia Impact Questionnaire

  2. Change in Generic quality of life

    Time frame: Baseline and after 6 and 12 weeks

    Measured by the Medical Outcome Survey Short Form 36

  3. Change in Functional capacity

    Time frame: Baseline and after 6 and 12 weeks

    Measured by the 6-minute Walk Test

  4. Change in strength

    Time frame: Baseline and after 6 and 12 weeks

    Measured by the 1 repetition maximum

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 17, 2018
Registry last updated
Jul 17, 2018

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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