Plain English Summary
Background and study aims:
Knee osteoarthritis is a major cause of chronic disability in older adults worldwide. The symptoms can be knee pain and morning stiffness. The patients might feel weakness in their thigh (quadriceps) muscles and have difficulty with the activities of daily living. The results of previous studies suggest that a simple walking programme can reduce pain and improve function and quality of life in patients with knee osteoarthritis. Retro walking might provide additional benefits to those associated with forward walking. The aim of this study is to investigate the effect of retro and forward walking on quadriceps muscle strength, pain, function, and mobility in individuals with knee osteoarthritis.
Who can participate?
Individuals with a diagnosis of knee osteoarthritis, aged 40–70 years old.
What does the study involve?
Participants are randomly allocated to one of three groups (A, B and C). Group A have two sessions (10 minutes each) of retro walking. Group B have two sessions (10 minutes each) of forward walking. Patients in groups A and B also receive a standard physiotherapy training programme. Group C receive only a standard physiotherapy programme.
What are the possible benefits and risks of participating?
The benefits of the retro and forward walking programmes are improvements in knee pain, disability, and quality of life; another benefit of the retro walking programme is increase in the quadriceps strength. The risks of the programmes are minimum or none.
Where is the study run from?
King Saud University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
March 2014 to December 2015
Who is funding the study?
King Saud University (Saudi Arabia)
Who is the main contact?
Mr Shahnawaz Anwer
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of a backward and forward walking programme on the strength, pain, function and mobility of the quadriceps in patients with knee osteoarthritis: a randomised controlled trial
Acronym
Study hypothesis
1. Retro and forward walking as an adjunct to a standard physiotherapy programme has significant effects on quadriceps muscle strength, pain, function, and mobility in patients with osteoarthritis knee.
2. There are significant differences in the effects of retro and forward walking as an adjunct to standard physiotherapy programme on quadriceps muscle strength, pain, function, and mobility in patients with osteoarthritis knee.
Ethics approval
Ethics subcommittee, Rehabilitation Research Chair, King Saud University, Riyadh, Saudi Arabia, 20/04/2014, ref: RRC-2014-010
Study design
Double-blind 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 to request a patient information sheet
Condition
Knee osteoarthritis
Intervention
Participants will be randomised to one of three groups:
1. Group A participants will have two sessions (10 minutes each) of the retro walking programme with 5 minutes of warm up and cool down for 3 days a week for 6 weeks on a flat surface at their maximum pace along with a standard physiotherapy programme. They will gradually increase the walking time up to half an hour. Individuals will do ankle toe movements, hamstring stretching, gastrosoleus stretching and heel-raise exercises during warm up and cool down.
2. Group B participants will have two sessions (10 minutes each) of the forward walking programme with 5 minutes of warm up and cool down for 3 days a week for 6 weeks on a flat surface at their maximum pace along with a standard physiotherapy programme. They will gradually increase the walking time up to half an hour. Individuals will do ankle toe movements, hamstring stretching, gastrosoleus stretching and heel-raise exercises during warm up and cool down.
3. Group C participants (control) will receive only a standard physiotherapy programme.
Outcomes will be measured at baseline and at the end of week 6.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Knee pain, measured with the Numeric Rating Scale
2. Knee function, measured with the Western Ontario and McMaster University Osteoarthris
Index
Outcomes will be measured at baseline and at the end of week 6.
Secondary outcome measures
1. Isometric quadriceps muscle strength, measured with a hand-held dynamometer
2. Mobility, measured with the timed up and go test
Outcomes will be measured at baseline and at the end of week 6.
Overall trial start date
01/03/2014
Overall trial end date
30/12/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Physician-diagnosed knee osteoarthritis, based on the American College of Rheumatology clinical and radiographic diagnostic criteria
2. Age 40–70
3. Kellgren-Lawrence grade of 1–3
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
69
Participant exclusion criteria
1. History of knee surgery within the past 3 months
2. Received physical therapy and an intra-articular injection for the knee within the past 3 months
3. History of a systemic arthritic condition
4. History of any other muscular, joint or neurological condition affecting the function of the lower limb
Recruitment start date
03/08/2014
Recruitment end date
30/10/2015
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
College of Applied Medical Sciences, King Saud University
Building Number 24
G095/1
PO Box 10219
Riyadh
11433
Saudi Arabia
Funders
Funder type
University/education
Funder name
King Saud University
Alternative name(s)
KSU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Saudi Arabia
Results and Publications
Publication and dissemination plan
The full study results will be published in mid 2017.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Shahnawaz Anwer.
Intention to publish date
30/06/2017
Participant level data
Available on request
Results - basic reporting
See additional file ISRCTN12850845_BasicResults_13Jan17.docx
Publication summary
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27072798
Publication citations
Additional files
- ISRCTN12850845_BasicResults_13Jan17.docx Uploaded 25/01/2017