Aerobic exercise training in addition to conventional physiotherapy for chronic low back pain

ISRCTN	ISRCTN23753357
DOI	https://doi.org/10.1186/ISRCTN23753357
Secondary identifying numbers	N/A

Submission date: 27/04/2010
Registration date: 30/04/2010
Last edited: 30/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ella Yeung
Scientific

Department of Rehabilitation Sciences
Hong Kong Polytechnic University
Hung Hom
Kowloon
-
Hong Kong

Email	rsella@polyu.edu.hk

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Aerobic exercise training in addition to conventional physiotherapy for chronic low back pain: a randomised controlled trial
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2006
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	46
Key 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
Key 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 workers compensation claims. 5. Have had physiotherapy treatment for back pain in the three months before recruitment
Date of first enrolment	01/03/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Hong Kong

Study participating centre

Department of Rehabilitation Sciences

Kowloon
-
Hong Kong

Sponsor information

Hong Kong Polytechnic University (Hong Kong)
University/education

c/o Ella Yeung
Department of Rehabilitation Sciences
Hung Hom
Kowloon
Kowloon
-
Hong Kong

"ROR"	https://ror.org/0030zas98

Funders

Funder type

University/education

Hong Kong Polytechnic University (Hong Kong) - Administrative costs

No information available

David Trench Rehabilitation Centre (Hong Kong) - Equipment costs

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan