Progressive Resistance Training for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588208
• Other study ID #: CEP UNIFESP 482056
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: March 25, 2018

Study information

• Verified date: July 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 25, 2018
• Est. primary completion date: September 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Progressive resistance training program
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
Structured education program were performed during one hour class once a week for five weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Measured by numerical pain scale	Baseline and after 6 and 12 weeks
Secondary	Change in Health related quality of life	Measured by Fibromyalgia Impact Questionnaire	Baseline and after 6 and 12 weeks
Secondary	Change in Generic quality of life	Measured by the Medical Outcome Survey Short Form 36	Baseline and after 6 and 12 weeks
Secondary	Change in Functional capacity	Measured by the 6-minute Walk Test	Baseline and after 6 and 12 weeks
Secondary	Change in strength	Measured by the 1 repetition maximum	Baseline and after 6 and 12 weeks