Contact information
Type
Scientific
Primary contact
Dr Ella Yeung
ORCID ID
Contact details
Department of Rehabilitation Sciences
Hong Kong Polytechnic University
Hung Hom
Kowloon
-
Hong Kong
rsella@polyu.edu.hk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Aerobic exercise training in addition to conventional physiotherapy for chronic low back pain: a randomised controlled trial
Acronym
Study hypothesis
The hypothesis of the study was to determine if the addition of aerobic exercise to conventional physiotherapy treatment for patients with chronic LBP had an additive effect on reducing pain and disability.
Ethics approval
1. Hong Kong Polytechnic University Human Subjects Ethics Sub-committee approved on the 20th of December 2005 (ref: HSEARS20051220001)
2. Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster approved on the 17th of January 2006 (ref: UW 06-013 T/1038)
Study design
Single centre interventional randomised controlled trial
Group assignments: computer-generated random number table; blocks of 4
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Chronic low back pain
Intervention
Participants in the intervention and control group received 8 weeks of intervention. All participants were supervised by a physiotherapist for each treatment session. Participants in the intervention group received conventional physiotherapy program and a progressive aerobic training program. The control group only received conventional physiotherapy treatment. Evaluations were performed at the 8-week intervention and at 12 months follow up.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Pain as measured with a 100mm visual analogue scale (VAS), evaluated at baseline and at 8 weeks
2. Functional disability using Aberdeen Low Back Pain Disability Scale (ALBPS). The disability scale ranged between 0 and 72, with higher scores representing greater back pain severity. The scores were converted to a scale of 0 to 100 for comparison. These were evaluated at baseline, 8 weeks and 12 months.
Secondary outcome measures
Physical fitness parameters measured at baseline and at 8 weeks. The parameters evaluated were aerobic capacity, muscular endurance, flexibility and body fat composition.
Overall trial start date
01/03/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Participants who had low back pain (LBP) symptoms for at least 12 weeks
2. Medically fit for physical fitness testing
3. Either sex, age 18-60
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
1. Cardiorespiratory conditions that affected the ability to participate in an aerobic exercise training program
2. Evidence of possible systemic disease
3. Inflammatory disease or malignancy
4. Treated on workersÂ’ compensation claims.
5. Have had physiotherapy treatment for back pain in the three months before recruitment
Recruitment start date
01/03/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Department of Rehabilitation Sciences
Kowloon
-
Hong Kong
Funders
Funder type
University/education
Funder name
Hong Kong Polytechnic University (Hong Kong) - Administrative costs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
David Trench Rehabilitation Centre (Hong Kong) - Equipment costs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary