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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02748291
Other study ID # G11122014 SoM ROD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date September 2016

Study information

Verified date July 2022
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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.
Department of Health Physical Activity Guidelines
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. 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. Adults should also undertake physical activity to improve muscle strength on at least two days a week. All adults should minimise the amount of time spent being sedentary (sitting) for extended periods.

Locations

Country Name City State
United Kingdom University of Nottingham Nottingham Nottinghamshire

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Objective assessment of participant aerobic capacity and physical function measured in the 6 Minute Walk Test 12 weeks
Secondary Participant subjective opinion on their knee and associated symptoms measured by KOOS (Knee Injury and Osteoarthritis Score) 12 weeks
Secondary Participant subjective opinion on their knee measured by WOMAC (Western Ontario and McMaster Universities Arthritis Index) Score 12 weeks
Secondary Participant subjective opinion on their knee measured by OKS (Oxford Knee Score) 12 weeks
Secondary Pain assessed VAS (Visual Analogue Scale) for knee pain 12 weeks
Secondary Participant subjective opinion of their general and mental health assessed by SF36 (Short Form Health Survey) 12 weeks
Secondary Objective assessment of participant physical function measured by OARSI (Osteoarthritis Research Society International) recommended functional tests for knee osteoarthritis - 30 second chair stand test 12 weeks
Secondary 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 12 weeks
Secondary Objective assessment of participant physical function measured by OARSI (Osteoarthritis Research Society International) recommended functional tests for knee osteoarthritis - stair climb test 12 weeks
Secondary Objective assessment of participant physical function measured by OARSI (Osteoarthritis Research Society International) recommended functional tests for knee osteoarthritis - up and go test 12 weeks
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