NCT03588208

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

July 4, 2018

Last Update Submit

July 4, 2018

Conditions

Keywords

FibromyalgiaPainFunctionQuality of life

Outcome Measures

Primary Outcomes (1)

  • Change in pain

    Measured by numerical pain scale

    Baseline and after 6 and 12 weeks

Secondary Outcomes (4)

  • Change in Health related quality of life

    Baseline and after 6 and 12 weeks

  • Change in Generic quality of life

    Baseline and after 6 and 12 weeks

  • Change in Functional capacity

    Baseline and after 6 and 12 weeks

  • Change in strength

    Baseline and after 6 and 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL
Other: Progressive resistance training programOther: Educational Program

Control Group

ACTIVE COMPARATOR
Other: Educational Program

Interventions

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.

Intervention Group

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

Control GroupIntervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 17, 2018

Study Start

February 1, 2016

Primary Completion

September 2, 2017

Study Completion

March 25, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07