Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain
Condition: Muscular Disease; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Musculoskeletal Pain; Muscular Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Aerobic exercise; Qigong exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Muscular Disease; Fibromyalgia; Exercise Therapy; Qigong; Aerobic Exercise; pediatrics