NCT00312234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

April 5, 2006

Last Update Submit

December 17, 2013

Conditions

Keywords

Muscular DiseaseFibromyalgiaExercise TherapyQigongAerobic Exercisepediatrics

Outcome Measures

Primary Outcomes (7)

  • 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

Interventions

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 8-18 years
  • Diagnosis of childhood fibromyalgia or chronic musculoskeletal pain (ACR criteria)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bloorview MacMillan Children's Centre

Toronto, Ontario, M2J 4S9, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Muscular DiseasesFibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Brian Feldman, MSc MD FRCPC

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Rheumatology

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 7, 2006

Study Start

August 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations