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Trial record 2 of 7 for:    14613558 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02748291
Recruitment Status : Unknown
Verified April 2016 by University of Nottingham.
Recruitment status was:  Active, not recruiting
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Pain Arthritis Gonarthritis Sedentary Knee Osteoarthritis Motor Activity Physical Activity Other: Walking Other: Department of Health Physical Activity Guidelines Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Investigation Into the Role of Walking in Treating the Symptoms of Knee Osteoarthritis: The WalkOut Study
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Objective assessment of participant aerobic capacity and physical function measured in the 6 Minute Walk Test [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Participant subjective opinion on their knee and associated symptoms measured by KOOS (Knee Injury and Osteoarthritis Score) [ Time Frame: 12 weeks ]
  2. Participant subjective opinion on their knee measured by WOMAC (Western Ontario and McMaster Universities Arthritis Index) Score [ Time Frame: 12 weeks ]
  3. Participant subjective opinion on their knee measured by OKS (Oxford Knee Score) [ Time Frame: 12 weeks ]
  4. Pain assessed VAS (Visual Analogue Scale) for knee pain [ Time Frame: 12 weeks ]
  5. Participant subjective opinion of their general and mental health assessed by SF36 (Short Form Health Survey) [ Time Frame: 12 weeks ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748291


Locations
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United Kingdom
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Kimberley L Edwards, MMedSci PhD University of Nottingham

Additional Information:
Publications:
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02748291     History of Changes
Other Study ID Numbers: G11122014 SoM ROD
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
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
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases