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Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00312234
First Posted: April 7, 2006
Last Update Posted: December 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children
  Purpose

This study is comparing two different exercise programs, Qi Gong (gentle stretching, and breathing) with an aerobics program (boxing and dancing) to see if children with chronic pain or fibromyalgia are able to take part in the program. We would also like to know if it is easy to take part in an exercise program.

We hypothesize that children with chronic musculoskeletal pain and FM, who engage in Qigong fitness training, will be more compliant, and have an equivalent or possibly superior improvement on measures of motor function (peak power, endurance, and metabolic efficiency) compared to children given an aerobic fitness exercise program.


Condition Intervention Phase
Muscular Disease Fibromyalgia Behavioral: Aerobic exercise Behavioral: Qigong exercise Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Feasibility and Impact of Qigong as Compared to Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain: A Pilot Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Brian Feldman, The Hospital for Sick Children:

Primary Outcome Measures:
  • Accrual rates
  • Compliance with therapy
  • Acceptability of exercise program
  • Degree of conditioning of subjects at baseline
  • Proportion of completed exercise tests and questionnaires
  • Dropout rates
  • Estimates of the effect sizes for exercise tests and questionnaire data

Estimated Enrollment: 30
Study Start Date: August 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Background: Childhood fibromyalgia (FM) and chronic musculoskeletal pain are common and sometimes devastating pediatric disorders resulting in widespread pain, fatigue, tenderness and significant disability. Exercises, including vigorous aerobics, and complementary and alternative health strategies - like Qigong - have shown to be safe and effective in the treatment of adult FM and chronic pain. Qigong may be more tolerable than more vigorous exercise. No data is available for this treatment in children.

Research Question: To test the feasibility of studying Qigong exercise versus aerobic fitness exercise to reduce symptoms and disability in children with FM or chronic pain.

Methods: Randomized single-blind pilot study of 30 childhood FM/chronic pain patients allocated to either 12 weeks of supervised Qigong therapy or 12 weeks of supervised graded aerobic exercise training (cardio-karate).

Expected Results: Physical exercise training - whether Qigong or aerobic exercise - represents a potentially feasible, safe and effective alternative therapy and may increase the ability for these children to resume their normal activities of daily life. Exercise training may therefore emerge as a pivotal mode of therapy for all children with FM/chronic pain. Results from our study will allow us to plan a definitive study.

Specific Objectives: 1. To study the feasibility of enrolling, randomizing and studying participants with FM/chronic pain using validated measures of symptoms, physical and psychosocial function, quality of life and exercise testing. 2. Acquire pilot data that will allow for the estimation of an effect size for the comparison of 2 forms of exercise - standard aerobic fitness exercise, and a specially designed Qigong program. This effect size estimate will be used in designing a subsequent definitive randomized controlled trial.

  Eligibility

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 8-18 years
  • Diagnosis of childhood fibromyalgia or chronic musculoskeletal pain (ACR criteria)

Exclusion Criteria:

  • Co-morbidity with cardiac, pulmonary or metabolic disease.
  • Children who engage in more than 3 hours of structured extracurricular physical activity programs weekly, unless a physiotherapy pool program with emphasis on joint range of motion and stretching.
  • Children who are unable to cooperate with testing procedures.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312234


Locations
Canada, Ontario
Bloorview MacMillan Children's Centre
Toronto, Ontario, Canada, M2J 4S9
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Brian Feldman, MSc MD FRCPC The Hospital for Sick Children
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Feldman, Division Head, Rheumatology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00312234     History of Changes
Other Study ID Numbers: 1000007434
First Submitted: April 5, 2006
First Posted: April 7, 2006
Last Update Posted: December 18, 2013
Last Verified: December 2013

Keywords provided by Brian Feldman, The Hospital for Sick Children:
Muscular Disease
Fibromyalgia
Exercise Therapy
Qigong
Aerobic Exercise
pediatrics

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms