An interventional study of Diet Only and Diet plus Exercise in Knee Osteoarthritis, sponsored by University of Bath. Status unknown at 1 site in United Kingdom. Open to participants aged 45 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by University of Bath · Not applicable, Interventional, and Treatment
The investigators are looking at the effects of energy restriction, with or without exercise on markers of inflammation in individuals with knee osteoarthritis. There will be a 4 week 'wash-in' period where participants will maintain their normal lifestyle, followed by a 4 week 'intervention period' where participants will be randomised into either the diet alone group or the diet plus exercise group.
Knee Osteoarthritis is a condition that causes pain, reduced physical function and quality of life. Long-term studies have shown that exercise and substantial weight loss can cause improvements in these factors. Individuals with knee Osteoarthritis might have changes in their joint that can be seen with x-ray images. However, this is not guaranteed, and imaging does not always detect changes that occur with interventions that cause improved symptoms. As a result, there is interest in biological markers (biomarkers) as another way of monitoring Osteoarthritis. These markers can be examined in biological tissues, with samples measured in blood easier to obtain than those taken from the fluid within the joint itself. Historically, Osteoarthritis was thought of as a disease caused by mechanical factors but we are now aware that inflammation also plays a part.
Therefore, the investigators aim to test a short -term diet/exercise intervention that has been show to improve inflammation in other populations, in individuals with knee osteoarthritis. Importantly, this will allow the investigators to see if reducing food intake alone or doing this with regular exercise can improve outcomes without substantial weight loss. The investigators will ask individuals to participate in one of two groups where they will first be asked to continue their normal lifestyle for 4 weeks to check the stability of outcomes. The investigators will then ask individuals to either reduce their food intake by 5000 calories per week, or do this while also completing moderate intensity cycling exercise 5 times a week for 4 weeks. At the start and end of each period the investigators will collect a blood sample to assess markers of inflammation and disease related processes. The investigators will also conduct questionnaire measurements, tests of physical function and experimental pain and scan participants to establish body composition.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 32 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Bath is the lead sponsor of 94 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Reduced calorie intake by 5000kcals per week over a 4 week period
Other: Diet Only
Reduced calorie intake by 5000kcals per week over 4 weeks with the addition of five 30 minute exercise sessions per week on a cycle ergometer. The exercise in intensity will be progressive and perceptually based and monitored by the investigators.
Other: Diet plus Exercise
Participants caloric intake will be reduced by 5000kcal per week over 4 weeks
Participants caloric intake will be reduced by 5000kcal per week over 4 weeks. Participants will also be asked to perform 5x30 minute cycling exercise sessions at home. Each week the intensity of exercise will be increased (week 1 = RPE 12, week 2 = RPE 13, week 3 = RPE 14, week 4 = RPE 15)
Change in hsCRP
Measured in mg/L via immunoassay
Time frame: 0, 4 and 8 weeks
Other Systemic Biomarkers
Measured in pg/ml via electrochemiluminescence * Interleukin-1 Beta * Interleukin-1Receptor Antagonist * Interleukin- 4 * Interleukin- 6 * Interleukin- 8 * Interleukin- 10 * Interleukin- 13 * Interleukin-17A * Interleukin-18 * Tumor Necrosis Factor- alpha
Time frame: 0, 4 and 8 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain, Symptoms, Activity of daily living, Sport/Rec, Quality of Life subscales. Each subscale has a minimum score of 0% and a maximum score of 100%, with lower values representing worse outcomes.
Time frame: 0, 4 and 8 weeks
EQ-5D-5L Health Questionnaire
Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. Each of the five dimensions comprising the EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems A unique health state is defined by combining one level from each of the five dimensions.
Time frame: 0, 4 and 8 weeks
SF-36 Questionnaire
Physical functioning, Bodily pain, Role limitations due to physical health problems, Role limitations due to personal or emotional problems, Emotional well-being, Social functioning, Energy/fatigue, and General health perceptions. Scores for each domain range from 0 to 100, with a higher score defining a more favourable health state.
Time frame: 0, 4 and 8 weeks
Visual Analogue Scale (VAS) Pain
0-10 scale Higher scores indicate worse pain
Time frame: 0, 4 and 8 weeks
30-second chair stand test
Repetitions
Time frame: 0, 4 and 8 weeks
40m fast paced walk
meters/second
Time frame: 0, 4 and 8 weeks
Stair climb
seconds
Time frame: 0, 4 and 8 weeks
Timed up and go test
seconds
Time frame: 0, 4 and 8 weeks
Mechanical Detection Threshold
millinewtons (mN)
Time frame: 0, 4 and 8 weeks
Pressure Pain Threshold
Newtons (N)
Time frame: 0, 4 and 8 weeks
Body Mass Index
kg/m2
Time frame: 0, 4 and 8 weeks
Hip and Waist Circumference
centimetres
Time frame: 0, 4 and 8 weeks
Body Composition
Change in body composition via Dual Energy XX-Ray Absorptiometry scan
Time frame: 0, 4 and 8 weeks
Markers of metabolic health
mmol/L * Glucose * Non-Esterified Fatty Acids * Triglycerides * Total cholesterol * Low Density Lipoprotein Cholesterol * High Density Lipoprotein Cholesterol
Time frame: 0, 4 and 8 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Anonymous individual data for all outcomes may be made available.
Started Jan 2022 (actual). Primary completion is estimated for Aug 2023, 19 months after the start.
Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 19 months is close to that.
Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University of Bath