Condition category
Musculoskeletal Diseases
Date applied
08/09/2008
Date assigned
08/01/2009
Last edited
28/09/2009
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 Deirdre Hurley

ORCID ID

Contact details

UCD Health Sciences Centre
Belfield
Dublin
D14
Ireland
+ 353 (0)1 7166515
deirdre.hurleyosing@ucd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2007-1

Study information

Scientific title

A single-blinded randomised controlled trial exploring the effectiveness of a walking programme and a supervised general exercise programme versus usual physiotherapy for chronic low back pain

Acronym

SWIFT Trial

Study hypothesis

In people referred for physiotherapy for chronic low back pain (LBP) there is no difference in clinical outcome and costs between those receiving a walking programme, a supervised general exercise programme and usual physiotherapy.

Ethics approval

Research Ethics Committees:
1. Connolly Hospital Blanchardstown, Dublin: 21st September 2007
2. Beaumont Hospital, Dublin: 9th October 2007 (ref: 07/63)
3. Mater Hospital, Dublin: 21st November 2007 (ref: 1/378/1135)
4. Adelaide and Meath Hospital, Dublin: 14th September 2007 (ref: 2007/09/09)

Study design

Single-blind multicentre randomised controlled trial

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 the contact details below to request a patient information sheet

Condition

Chronic low back pain

Intervention

1. Walking programme (WP):
Within two weeks of randomisation participants will commence participation in the WP at each participating hospital through an appointment with a Chartered Physiotherapist. The focus will be on increasing physical activity through a graded walking programme. As with the SEC (see below), each participant will attend the physiotherapy department for an individual initial assessment, where there will be discussion and agreement between the therapist and the patient on short and long-term goals; recording of the patient's exercise capabilities and perceived barriers to recovery and the individual's treatment expectations. Each subject will be given a pedometer to wear for seven days to record habitual daily activity levels. The subject will then re-attend and using the information recorded from the pedometer, a starting point for the eight week progressive walking programme will be established; the minimum being a 10-minute walk (approx 1200 steps) on at least four days per week to be decided with, where possible, one day's rest between walks. The aim of the programme is to progress to the ACSM guidelines of 30 minutes moderate intensity walking on five days per week by week five and then to maintain this level for the remainder of the programme. All participants will use their Yamax Digiwalker Pedometer as a motivational feedback tool, providing immediate information on activity levels. Adherence with the walking programme will be assessed by the frequency, distance, number of steps taken and duration of walks recorded in a training diary.

The subjects will be contacted once per week by the Chartered Physiotherapist who performed the initial assessment by telephone to progress their walking frequency and duration and provide encouragement, and will reattend the Physiotherapy Department at the end of the intervention for reassessment and discharge from physiotherapy.

2. Supervised exercise class (SEC):
Within two weeks of randomisation, participants will commence the SEC. This class will follow a group-based format based on the 'Back to Fitness' programme used in the recently published UK BEAM trial. Each participant will attend the physiotherapy department for an initial individual assessment prior to the class, where there will be discussion and agreement between the therapist and the patient on short and long-term goals; recording of the patient's exercise capabilities and perceived barriers to recovery and the individual's treatment expectations. Participants will then attend the physiotherapy department of the relevant participating hospital once a week for 8 weeks for a one-hour supervised group exercise class led by a Chartered Physiotherapist. The physiotherapist will advise patients according to their individual goals and exercise capabilities, and help identify which exercise(s) they could continue independently of the treatment sessions, i.e. foster the development of self-management strategies. Subjects will also be required to rate their perceived exertion during the class on the Borg scale. Patients will be encouraged to accept responsibility for determining and carrying out their weekly programme of activity.

3. Usual physiotherapy (UP - control group):
Within two weeks of randomisation, participants randomised to the UP group will commence individual physiotherapy at the discretion of the treating physiotherapist in the participating hospital. All physiotherapy treatments will be recorded for the study period in previously designed treatment record forms. On the basis of a previous RCT by the research team in the Republic of Ireland Public Physiotherapy Health Service the anticipated mean (SD) number of treatments is 5.8 (3) over a mean (SD) of 7.7 weeks (5.8) weeks. A multimodal approach of education/advice, manipulative therapy and exercise therapy will be permitted on the basis of the results of previous surveys of physiotherapy practice in the UK and Ireland by the researchers. As part of this it is expected that subjects will be provided with an individualised exercise programme at the discretion of the treating therapist but will not be permitted to attend group exercise classes during the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Oswestry Disability Index, measured at 3, 6 and 12 months by postal follow-up.

Secondary outcome measures

1. Pain using a Numerical Rating Scale
2. Health-related quality of life measured by the EuroQol questionnaire
3. Psychosocial beliefs using the Fear Avoidance Beliefs Questionnaire and the Back Beliefs Questionnaire
4. Number of days reported sick leave over the past year for those in paid employment only
5. Physical activity levels using the International Physical Activity Questionnaire (IPAQ), an exercise diary and the activPalTM accelerometer
6. Patient satisfaction will be assessed using Likert scales assessing satisfaction with outcome and satisfaction with care
7. Self efficacy questionnaire

The outcomes will be measured at 3, 6 and 12 months by postal follow-up.

Overall trial start date

01/10/2008

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with chronic (greater than or equal to three months) or recurrent (greater than or equal to three episodes in previous 12 months) LBP of mechanical origin with/without radiation to the lower limb
2. Males/females between 18 - 65 years
3. No spinal surgery within the previous 12 months
4. Patients deemed suitable by their General Practitioner (GP)/hospital consultant to carry out an exercise programme
5. Patients willing to attend for an 8-week treatment programme of exercise classes
6. Access to a telephone (for follow-up support)
7. Fluency in English (verbal and written)
8. Low levels of physical activity measured by the International Physical Activity Questionnaire (IPAQ) (less than 600 MET-minutes/week)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

246

Participant exclusion criteria

1. Currently or having received treatment for chronic low back pain (CLBP) within previous three months
2. Red flags indicating serious spinal pathology, e.g. cancer, cauda equina lesion
3. Radicular pain indicative of nerve root compression
4. Patients diagnosed with severe spinal stenosis, spondylolisthesis, fibromyalgia
5. History of systemic/inflammatory disease, e.g. rheumatoid arthritis
6. Patients with any confounding conditions such as a neurological disorder or currently receiving treatment for cancer
7. Patients with acute (less than six weeks) or subacute LBP (6 - 12 weeks), provided that they have experienced less than three LBP episodes during previous 12 months
8. Unstable angina/uncontrolled cardiac dysrhythmias/severe aortic stenosis/acute systemic infection accompanied by fever
9. Medico-legal issues

Recruitment start date

01/10/2008

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Ireland

Trial participating centre

UCD Health Sciences Centre
Dublin
D14
Ireland

Sponsor information

Organisation

Health Research Board (HRB) (Ireland)

Sponsor details

73 Lower Baggot Street
Dublin
D2
Ireland
+353 (0)1 234 5000
help@hrb.ie

Sponsor type

Government

Website

http://www.hrb.ie/display_content.php?page_id=8

Funders

Funder type

Government

Funder name

Health Research Board (HRB) (Ireland) (ref: 2007-79)

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

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

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19573247

Publication citations

  1. Protocol

    Hurley DA, O'Donoghue G, Tully MA, Moffett JK, van Mechelen W, Daly L, Boreham CA, McDonough SM, A walking programme and a supervised exercise class versus usual physiotherapy for chronic low back pain: a single-blinded randomised controlled trial. (The Supervised Walking In comparison to Fitness Training for Back Pain (SWIFT) Trial)., BMC Musculoskelet Disord, 2009, 10, 79, doi: 10.1186/1471-2474-10-79.

Additional files

Editorial Notes