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

Fibromyalgia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312234
• Other study ID #: 1000007434
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2006
• Last updated: December 17, 2013
• Start date: August 2005
• Est. completion date: August 2007

Study information

• Verified date: December 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Muscular Disease
• Muscular Diseases
• Musculoskeletal Pain
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Aerobic exercise

• Qigong exercise

Locations

Country	Name	City	State
Canada	Bloorview MacMillan Children's Centre	Toronto	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rates
Primary	Compliance with therapy
Primary	Acceptability of exercise program
Primary	Degree of conditioning of subjects at baseline
Primary	Proportion of completed exercise tests and questionnaires
Primary	Dropout rates
Primary	Estimates of the effect sizes for exercise tests and questionnaire data