Muscular DiseasePhase 2NCT00312234
Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain
A Phase 2 study testing Aerobic exercise and Qigong exercise in people with Muscular Disease and Fibromyalgia, run by The Hospital for Sick Children at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Muscular Disease, Fibromyalgia
- What is being tested?
- Aerobic exercise and Qigong exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2005to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-18 years
- Diagnosis of childhood fibromyalgia or chronic musculoskeletal pain (ACR criteria)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Bloorview MacMillan Children's Centre
Toronto, Ontario, M2J 4S9
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
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.
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.
Read the 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.
- Conditions
- Muscular Disease, Fibromyalgia
- Being tested
- Aerobic exercise, Qigong exercise
- Keywords
- Muscular Disease, Fibromyalgia, Exercise Therapy, Qigong, Aerobic Exercise, pediatrics
- Medical subject headings
- Muscular Diseases, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Qigong exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startAug 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscular DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Feldman, The Hospital for Sick Children
- Investigators
- Brian Feldman, MSc MD FRCPC, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312234
- Sponsor's protocol ID
- 1000007434
- Status last verified
- Dec 2013
- First submitted
- 5 Apr 2006
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
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.
PubMed 18821656
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00312234
- Acronym / sponsor ID
- 1000007434
- Conditions
- Muscular Disease, Fibromyalgia
- Keywords
- Muscular Disease, Fibromyalgia, Exercise Therapy, Qigong, Aerobic Exercise, pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 7 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 8-18 years
- Diagnosis of childhood fibromyalgia or chronic musculoskeletal pain (ACR criteria)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise | Behavioural | – |
| Qigong exercise | Behavioural | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Derived from this study: PubMed 18821656Stephens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Feldman, MSc MD FRCPC principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic exercise and Qigong exercise in people with Muscular Disease and Fibromyalgia, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rates. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00312234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.