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

NCT02748291 | Completed DMC

• 1 other identifier: G11122014 SoM ROD
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Pain; Arthritis; Gonarthritis; Sedentary; Knee Osteoarthritis; Motor Activity; Physical Activity

Keywords

Sedentary; Knee osteoarthritis; Knee pain; Gonarthritis; Arthritis; Walking; Pedometer; Physical Activity; Activities of Daily Function; Department of Health Physical Activity Guidelines; Improve pain; Decrease pain; Improve function; Increase function; Activity Monitoring; Monitoring, Ambulatory/instrumentation

Outcome Measures

Primary Outcomes (1)

• Objective assessment of participant aerobic capacity and physical function measured in the 6 Minute Walk Test

  12 weeks

Secondary Outcomes (9)

• Participant subjective opinion on their knee and associated symptoms measured by KOOS (Knee Injury and Osteoarthritis Score)

  12 weeks

• Participant subjective opinion on their knee measured by WOMAC (Western Ontario and McMaster Universities Arthritis Index) Score

  12 weeks

• Participant subjective opinion on their knee measured by OKS (Oxford Knee Score)

  12 weeks

• Pain assessed VAS (Visual Analogue Scale) for knee pain

  12 weeks

• Participant subjective opinion of their general and mental health assessed by SF36 (Short Form Health Survey)

  12 weeks

Study Arms (2)

Walking

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Department of Health (United Kingdom) Physical Activity Guidelines flyer (current standard of care).

Other: Department of Health Physical Activity Guidelines

Interventions

Walking OTHER

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.

Walking

Department of Health Physical Activity Guidelines OTHER

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.

Control

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (4)

• White DK, Tudor-Locke C, Zhang Y, Fielding R, LaValley M, Felson DT, Gross KD, Nevitt MC, Lewis CE, Torner J, Neogi T. Daily walking and the risk of incident functional limitation in knee osteoarthritis: an observational study. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1328-36. doi: 10.1002/acr.22362.

  PMID: 24923633 BACKGROUND

• Maddison R, Ni Mhurchu C, Jiang Y, Vander Hoorn S, Rodgers A, Lawes CM, Rush E. International Physical Activity Questionnaire (IPAQ) and New Zealand Physical Activity Questionnaire (NZPAQ): a doubly labelled water validation. Int J Behav Nutr Phys Act. 2007 Dec 3;4:62. doi: 10.1186/1479-5868-4-62.

  PMID: 18053188 BACKGROUND

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• Talbot LA, Gaines JM, Huynh TN, Metter EJ. A home-based pedometer-driven walking program to increase physical activity in older adults with osteoarthritis of the knee: a preliminary study. J Am Geriatr Soc. 2003 Mar;51(3):387-92. doi: 10.1046/j.1532-5415.2003.51113.x.

  PMID: 12588583 BACKGROUND

Related Links

• Nice.org.uk, (2012). Walking and cycling: local measures to promote walking and cycling as forms of travel or recreation \| Guidance and guidelines

MeSH Terms

Conditions

Osteoarthritis; Pain; Arthritis; Sedentary Behavior; Osteoarthritis, Knee; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Kimberley L Edwards, MMedSci PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sport Exercise & Nutrition Education

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 22, 2016
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)