Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain
Primary Purpose
Muscular Disease, Fibromyalgia
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Aerobic exercise
Qigong exercise
Sponsored by
About this trial
This is an interventional treatment trial for Muscular Disease focused on measuring Muscular Disease, Fibromyalgia, Exercise Therapy, Qigong, Aerobic Exercise, pediatrics
Eligibility 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.
Sites / Locations
- Bloorview MacMillan Children's Centre
- Hospital for Sick Children
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00312234
First Posted
April 5, 2006
Last Updated
December 17, 2013
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT00312234
Brief Title
Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Disease, Fibromyalgia
Keywords
Muscular Disease, Fibromyalgia, Exercise Therapy, Qigong, Aerobic Exercise, pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Qigong exercise
Primary Outcome Measure Information:
Title
Accrual rates
Title
Compliance with therapy
Title
Acceptability of exercise program
Title
Degree of conditioning of subjects at baseline
Title
Proportion of completed exercise tests and questionnaires
Title
Dropout rates
Title
Estimates of the effect sizes for exercise tests and questionnaire data
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Feldman, MSc MD FRCPC
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bloorview MacMillan Children's Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2J 4S9
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18821656
Citation
Stephens S, Feldman BM, Bradley N, Schneiderman J, Wright V, Singh-Grewal D, Lefebvre A, Benseler SM, Cameron B, Laxer R, O'Brien C, Schneider R, Silverman E, Spiegel L, Stinson J, Tyrrell PN, Whitney K, Tse SM. Feasibility and effectiveness of an aerobic exercise program in children with fibromyalgia: results of a randomized controlled pilot trial. Arthritis Rheum. 2008 Oct 15;59(10):1399-406. doi: 10.1002/art.24115.
Results Reference
derived
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Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain
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