NCT01253395

Brief Summary

Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

2 years

First QC Date

December 1, 2010

Last Update Submit

December 2, 2010

Conditions

Fibromyalgia

Keywords

ExercisePain

Outcome Measures

Primary Outcomes (1)

  • Pain severity

    Validated measure of clinical pain.

    Week 3

Secondary Outcomes (1)

  • Muscle strength

    Week 3

Study Arms (2)

Strength training

EXPERIMENTAL

Supervised strength training.

Behavioral: Strength training

Aerobic exercise

ACTIVE COMPARATOR

Supervised aerobic exercise.

Behavioral: Aerobic exercise

Interventions

Strength trainingBEHAVIORAL

Daily supervised strength training.

Strength training
Aerobic exerciseBEHAVIORAL

Daily supervised aerobic exercise.

Aerobic exercise

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Hooten WM, Rosenberg CJ, Eldrige JS, Qu W. Knee extensor strength is associated with pressure pain thresholds in adults with fibromyalgia. PLoS One. 2013;8(4):e59930. doi: 10.1371/journal.pone.0059930. Epub 2013 Apr 2.

    PMID: 23565175DERIVED

  • Hooten MW, Qu W, Townsend CO, Judd JW. Effects of strength vs aerobic exercise on pain severity in adults with fibromyalgia: a randomized equivalence trial. Pain. 2012 Apr;153(4):915-923. doi: 10.1016/j.pain.2012.01.020. Epub 2012 Feb 15.

    PMID: 22341565DERIVED

MeSH Terms

Conditions

FibromyalgiaMotor ActivityPain

Interventions

Resistance TrainingExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • William M Hooten, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

April 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

US(1)