Condition category
Musculoskeletal Diseases
Date applied
27/04/2010
Date assigned
30/04/2010
Last edited
30/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 workers’ 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

Sponsor information

Organisation

Hong Kong Polytechnic University (Hong Kong)

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes