Clinical trial NCT00312234: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscular Disease
Fibromyalgia
Keywords: Muscular Disease
Fibromyalgia
Exercise Therapy
Qigong
Aerobic Exercise
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2006-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Accrual rates
measure: Compliance with therapy
measure: Acceptability of exercise program
measure: Degree of conditioning of subjects at baseline
measure: Proportion of completed exercise tests and questionnaires
measure: Dropout rates
measure: Estimates of the effect sizes for exercise tests and questionnaire data
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Bloorview MacMillan Children's Centre
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Brian Feldman, MSc MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.