Effects of a walking programme on the strength, pain, function and mobility of the thigh muscles in patients with osteoarthritis of the knee
| ISRCTN | ISRCTN12850845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12850845 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/01/2015
- Registration date
- 26/01/2015
- Last edited
- 09/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Building Number 24, College of Applied Medical Sciences
G095/1, Rehabilitation Research Chair
King Saud University
Riyadh
11433
Saudi Arabia
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| 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 the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics subcommittee, Rehabilitation Research Chair, King Saud University, Riyadh, Saudi Arabia, 20/04/2014, ref: RRC-2014-010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2014 |
| Completion date | 30/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 69 |
| Total final enrolment | 68 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/08/2014 |
| Date of final enrolment | 30/10/2015 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
G095/1
PO Box 10219
Riyadh
11433
Saudi Arabia
Sponsor information
University/education
Building Number 24, College of Applied Medical Sciences
G095/1, Rehabilitation Research Chair
King Saud University
Riyadh
11433
Saudi Arabia
"ROR" |
https://ror.org/02f81g417 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- جامعة الملك سعود, KSU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 30/06/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/04/2016 | Yes | No | |
| Basic results | 13/01/2017 | 25/01/2017 | No | No | |
| Results article | 09/04/2019 | 09/02/2023 | Yes | No |
Additional files
- ISRCTN12850845_BasicResults_13Jan17.docx
- Uploaded 25/01/2017
Editorial Notes
09/02/2023: Publication reference and total final enrolment added.
18/12/2017: Internal review.
25/01/2017: Basic results summary uploaded.
14/04/2016: Publication reference added.
