WALK - A pilot randomised controlled trial evaluating community walking for knee osteoarthritis

Not Applicable

• Conditions: Knee osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12618001097235
• Lead Sponsor: Menzies Institute for Medical Research, University of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-02
• Study Completion: 2019-12-16
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1)Males and females aged 45 or over;
2)Have clinically diagnosed knee OA (according to the American College of Rheumatology criteria);
3)Have had symptomatic knee OA for at least 6 months with a pain visual analogue scale (VAS) score of at least 40mm/100mm over the last 7 days;
4)Have a bone marrow lesion (BML) present on MRI (prevalence 88% at screening in our recent clinical trial).
5)Have no difficulty in walking a city block (75-100 metres).
6)Be willing to participate in a walking program for 6 months, and can attend on days/times of the week that scheduled walking classes are running.

Exclusion Criteria

1)Severe knee pain (on standing greater than 80mm/100mm on VAS);
2)Participation in any form of exercise at a moderate/vigorous level for >150 min/week or walking >10,000 steps/day – will be assessed for 7 consecutive days during screening using Actigraph accelerometers (meta-analysis data demonstrates that few knee OA sufferers meet these levels of activity (13% and 19% respectively));
3)Any condition that precludes safe participation in exercise (i.e. fails the safety for exercise clearance; see below for the procedure for this);
4)Other forms of arthritis in which disease is active and concomitant medication is used (e.g., rheumatoid arthritis);
5)Participants who have undergone significant trauma to the ‘study’ knee in the previous 12 months (injury, arthroscopy or open surgery);
6)Receiving intra-articular therapy (e.g. corticosteroids, hyaluronic acid) in the study knee in the last 6 months;
7)Anticipated need for knee or hip surgery within the next 6 months;
8)Contra-indication to MRI (for example, implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, claustrophobia, knee too large for scanner);
9)Plan to commence exercise or another new treatment for knee OA in the next 6 months.
10)Use of a gait aid.
11)Inability to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Design: Any required changes to the study protocol (determined as the 'required changes needed' during the study and documented on a tracked changes version of the study protocol by study staff)<br><br><br><br><br>[During screening and every week of intervention from baseline to 6 months. ];Recruitment and Screening: Time and number of people screened to enrol 48 participants.[Time from recruitment commencement to when 48 participants are enrolled.];Balance of characteristics in each group including age, sex, BMI, and knee pain levels self-reported by VAS. [At 6 months from commencement of intervention. ]