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Exercise for Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01253395
First received: December 1, 2010
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention
Fibromyalgia
 Behavioral: Strength training
Behavioral: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Pain severity [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Validated measure of clinical pain.


Secondary Outcome Measures:
  • Muscle strength [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Assessment of muscle strength using a dynometer.


Enrollment: 72
Study Start Date: April 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strength training
Supervised strength training.
 Behavioral: Strength training
Daily supervised strength training.
Active Comparator: Aerobic exercise
Supervised aerobic exercise.
 Behavioral: Aerobic exercise
Daily supervised aerobic exercise.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

- Established diagnosis of fibromyalgia, age > 18 years. Exclusion Criteria: cardiac, pulmonary or orthopedic condition that would limit exercise.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253395

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: William M Hooten, MD Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: W. Michael Hooten, Md, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01253395     History of Changes
Other Study ID Numbers: 005-4167
Study First Received: December 1, 2010
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Exercise
Pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013