Trial record 1 of 1 for:    NCT01253395
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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014