An Investigation Into the Role of Walking in Treating the Symptoms of Knee Osteoarthritis: The WalkOut Study (WalkOut)

July 7, 2022 updated by: Kimberley Edwards, University of Nottingham

There are over 8.75 million people in the United Kingdom with osteoarthritis in their knees. The effect of this condition can be debilitating. Symptoms are due to wear and tear of the knee joint. Some people can suffer with knee pain and stiffness. This study will look at whether walking improves the symptoms of knee osteoarthritis.

Investigators will recruit anyone with knee pain over the age of 45 years in Nottingham. Participants will undergo a full assessment by a qualified Doctor. After assessment, Participants meeting the eligibility criteria will be invited to join the study. Participants will be randomly allocated into 2 groups. One group will receive standard health and exercise advice. The other group will be allocated a walking activity. This group will undertake 6,000 walking steps each day. Participants will provide pedometers to monitor this walking activity.

The effect of walking will be compared using questionnaires. These will look at pain levels, quality of life and physical activity. The participants will complete these questionnaires before the study, at the 6 week midpoint and at the end of the 12 week intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND - Over 8.75 million people in the United Kingdom have painful osteoarthritis in one or both knees and a third of people of 45 years old have sought treatment. It has been well established that physical activity in mild - moderate osteoarthritis can provide improvement in symptoms and physical function. Current research is evaluating what modality of physical activity is best to achieve these improvements. A preliminary pedometer study in 2003 demonstrated symptomatic and functional improvement in knee osteoarthritis. A recent observational study has found that increased walking activity, with 6,000 steps per day being optimal, decreased the risk of functional limitation in knee osteoarthritis. Therefore, the purpose of this study is test evaluate the effectiveness of these recent recommendations against current UK physical activity guidelines.

AIMS - The study aims to investigate the role of walking in achieving a subjective improvement in symptomatic osteoarthritis of the knee/s. Furthermore, the study will investigate whether walking improves performance based tests which objectively assess physical function in participants with knee osteoarthritis. Null hypothesis to be tested: There is no difference in a 12 week intervention of walking 6,000 steps, per day, in improving pain and self reported physical function, compared to the current Department of Health physical activity guidelines.

EXPERIMENTAL PROTOCOL AND METHODS - Participants will be recruited through poster advertisement and non-incentivised involvement. Potential participants will be sent a Patient Information Leaflet for the study and a Consent Form. Following consent, the participant will be screened by telephone to ensure participants meet the inclusion criteria and also to exclude participants who would not be eligible on their medical history and activity status alone. Eligible participants from screening will be invited for a formal assessment. The assessment will confirm that information given in the screening remains accurate and a focussed physical examination of the knee. Participants eligible at the end of end of assessment will be randomly allocation into the control and intervention group, both lasting 12 weeks. Block randomisation will be used and this will be prepared by an independent person. Participants, irrespective of their allocation, will complete the following questionnaires: KOOS (KOOS: Knee Injury and Osteoarthritis Outcome Score), IPAQ (IPAQ: International Physical Activity Questionnaire), VAS for knee pain (VAS: Visual Analogue Scale), OKS (OKS: Oxford Knee Score), SF36 (SF36: Short Form Health Survey) and WOMAC (WOMAC: Western Ontario and McMaster Universities Arthritis Index). The intervention group will be allocated a walking activity of 6,000 per day. Participants will be provided with a pedometer and diary so walking activity can be recorded and monitored. Weekly scores will be collected via telephone contact with the participant. The control group will be provided with the standard physical activity advice that participants would receive from their GP (GP: General Practitioner) regarding physical activity levels. Both groups will complete a further IPAQ questionnaire at the mid point of the study at 6 weeks to monitor physical activity levels. At 12 weeks at the end of study, all participants will repeat the initial questionnaires, KOOS, IPAQ, VAS, OKS, SF36 and WOMAC and the performance based tests.

MEASUREABLE ENDPOINTS - Objective outcomes from performance based testing will be assessed, OARSI (OARSI: Osteoarthritis Research Society International) recommended physical function tests (6 minute walk test). Secondary outcomes: Pain, reported physical function in daily activities/sport/recreation, knee related quality of life measures from the above mentioned questionnaires and 4 other OARSI recommended functional tests (30sec chair stand test, 40m fast paced walk test, stair climb test and up and go test) in addition to age, sex, BMI (Body Mass Index), ethnicity and occupation.

N.B. 6,000 steps roughly equates to 2.5 miles/4.3 km. This distance is based on 71 steps to cover 100m (Investigator's 100m pace). At a steady pace, on flat terrain, 1 mile can be covered in 15minutes. The distance and timing to complete 6,000 steps will vary between participants depending on their stride length and pace.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Following current NICE (The National Institute for Health Care Excellence) guidelines (United Kingdom) for diagnosing knee osteoarthritis:

  • Anyone over the age of 45 with painful knee/s
  • No morning stiffness or stiffness that lasts less than 30 minutes

Exclusion Criteria:

  • Exercise/activity > than current Department of Health physical activity guidelines
  • Stiffness > 30mins in the morning
  • Self-reported knee pathology (cruciate, meniscal, soft tissue, joint replacement)

  • Cardiac disease - any:

    • Acute coronary syndrome < 12 months
    • Unexplained arrhythmia
    • Angioplasty/cardiac surgery
    • Congestive Cardiac Failure
    • Valvular disease
    • Cardiomyopathy
    • Myocarditis
    • Uncontrolled Hypertension

  • Thrombolic events - any:

    • Cerebrovascular accident/transient ischaemic attack last 12 months
    • Deep vein thrombosis/pulmonary embolus last 6 months
  • Asthma/Chronic Obstructive Pulmonary Disease Peak Expiratory Flow Rate < 300L/min/frequent exacerbations
  • Anaemia Haemoglobin <90d/L
  • Mental illness/learning disabilities/terminal illness
  • Does not understand English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Walking
Randomised participants will be instructed to walk 6,000 steps per day and throughout the day for 12 weeks. Step counts will be monitored by an issued pedometer. A 12 week paper diary will be provided for daily recording of step counts.
Other: Walking

The intervention group will be asked to walk a minimum 6,000 steps per day (7 days a week).

Participants will be provided with a pedometer and daily diary to record step counts.

Weekly scores will be collected via telephone contact.

Followup questionnaires will be at 6, 12 and 24 months.
Active Comparator: Control
Department of Health (United Kingdom) Physical Activity Guidelines flyer (current standard of care).
Other: Department of Health Physical Activity Guidelines
  1. Adults should aim to be active daily. Over a week, activity should add up to at least 150 minutes (2½ hours) of moderate intensity activity in bouts of 10 minutes or more - one way to approach this is to do 30 minutes on at least 5 days a week.
  2. Alternatively, comparable benefits can be achieved through 75 minutes of vigorous intensity activity spread across the week or combinations of moderate and vigorous intensity activity.
  3. Adults should also undertake physical activity to improve muscle strength on at least two days a week.
  4. All adults should minimise the amount of time spent being sedentary (sitting) for extended periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective assessment of participant aerobic capacity and physical function measured in the 6 Minute Walk Test
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Participant subjective opinion on their knee and associated symptoms measured by KOOS (Knee Injury and Osteoarthritis Score)
Time Frame: 12 weeks
12 weeks
Participant subjective opinion on their knee measured by WOMAC (Western Ontario and McMaster Universities Arthritis Index) Score
Time Frame: 12 weeks
12 weeks
Participant subjective opinion on their knee measured by OKS (Oxford Knee Score)
Time Frame: 12 weeks
12 weeks
Pain assessed VAS (Visual Analogue Scale) for knee pain
Time Frame: 12 weeks
12 weeks
Participant subjective opinion of their general and mental health assessed by SF36 (Short Form Health Survey)
Time Frame: 12 weeks
12 weeks
Objective assessment of participant physical function measured by OARSI (Osteoarthritis Research Society International) recommended functional tests for knee osteoarthritis - 30 second chair stand test
Time Frame: 12 weeks
12 weeks
Objective assessment of participant physical function measured by OARSI (Osteoarthritis Research Society International) recommended functional tests for knee osteoarthritis - 40 metre fast paced walk test
Time Frame: 12 weeks
12 weeks
Objective assessment of participant physical function measured by OARSI (Osteoarthritis Research Society International) recommended functional tests for knee osteoarthritis - stair climb test
Time Frame: 12 weeks
12 weeks
Objective assessment of participant physical function measured by OARSI (Osteoarthritis Research Society International) recommended functional tests for knee osteoarthritis - up and go test
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Kimberley L Edwards, MMedSci PhD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G11122014 SoM ROD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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