Knee OsteoarthritisNCT05518890
Effect of Energy Restriction and Exercise for Knee Osteoarthritis
A study testing Diet Only and Diet plus Exercise in people with Knee Osteoarthritis, run by University of Bath at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 69 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Diet Only and Diet plus Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or post-menopausal females
- Clinically diagnosed with knee Osteoarthritis including radiographic confirmation
- Oxford Knee Score ≥20 to ≤35 for index knee
- Aged 45-69 years
- BMI ≥27.5kg/m2 to ≤40.0 kg/m2
- Daily physical activity level <2.00
Who cannot join
- Inability to undertake cycling exercise safely
- Use of prescribed anti-inflammatory medication
- Current smoker (or having quit <6months ago)
- Has a diagnosis of diabetes or other metabolic disorder
- Use of other medications that might interfere with study outcomes
- Recent (within last 3 months) change in body mass of >5%
Show all 11Show fewer
- Currently engaged in an ongoing programme of physiotherapy treatment
- Currently on waiting list or having had surgery for Osteoarthritis on the index knee (prior OA related surgery permitted on other knee as long as this is greater than 12 months prior to enrolment)
- Having had major hip/knee surgery within preceding 12 months
- Individuals with a blood pressure of greater than 180/110
- Currently pregnant or intending to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bath
Bath, BA27AY
Rachel Deere, 01225 385918, r.deere@bath.ac.uk
About this study
Official title: Effect of Short-term Negative Energy Balance With or Without Exercise on Systemic Biomarkers in Patients With Knee Osteoarthritis
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.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Diet Only, Diet plus Exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet OnlyOther
Participants caloric intake will be reduced by 5000kcal per week over 4 weeks
Diet plus ExerciseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Diet Only | Experimental | Reduced calorie intake by 5000kcals per week over a 4 week period Receives: Other: Diet Only |
| Diet plus Exercise | Experimental | 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. Receives: Other: Diet plus Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hsCRP
Measured in mg/L via immunoassay
Measured: 0, 4 and 8 weeks
Secondary outcomes (15)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 4 and 8 weeks
Visual Analogue Scale (VAS) Pain
0-10 scale Higher scores indicate worse pain
Measured: 0, 4 and 8 weeks
30-second chair stand test
Repetitions
Measured: 0, 4 and 8 weeks
40m fast paced walk
meters/second
Measured: 0, 4 and 8 weeks
Stair climb
seconds
Measured: 0, 4 and 8 weeks
Timed up and go test
seconds
Measured: 0, 4 and 8 weeks
Mechanical Detection Threshold
millinewtons (mN)
Measured: 0, 4 and 8 weeks
Pressure Pain Threshold
Newtons (N)
Measured: 0, 4 and 8 weeks
Body Mass Index
kg/m2
Measured: 0, 4 and 8 weeks
Hip and Waist Circumference
centimetres
Measured: 0, 4 and 8 weeks
Body Composition
Change in body composition via Dual Energy XX-Ray Absorptiometry scan
Measured: 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
Measured: 0, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, James Bilzon, University of Bath
- Investigators
- James Bilzon, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518890
- Sponsor's protocol ID
- 20/SW/0063
- Status last verified
- Aug 2022
- First submitted
- 29 Mar 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous individual data for all outcomes may be made available.
Publications
Deere R, Farrow M, Spellanzon B, Chowdhury E, Thompson D, Bilzon JLJ. The effects of short-term dietary calorie restriction combined with aerobic exercise on systemic inflammation in overweight or obese individuals with knee osteoarthritis: a randomised controlled trial. Musculoskelet Sci Pract. 2026 Apr;82:103505. doi: 10.1016/j.msksp.2026.103505. Epub 2026 Feb 6.
PubMed 41759492
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Negative Energy Balance With or Without Exercise on Systemic Biomarkers in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05518890
- Acronym / sponsor ID
- 20/SW/0063
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Only | Experimental | Other: Diet OnlyReduced calorie intake by 5000kcals per week over a 4 week period |
| Diet plus Exercise | Experimental | Other: Diet plus ExerciseReduced 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. |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or post-menopausal females
- Clinically diagnosed with knee Osteoarthritis including radiographic confirmation
- Oxford Knee Score ≥20 to ≤35 for index knee
- Aged 45-69 years
- BMI ≥27.5kg/m2 to ≤40.0 kg/m2
Key exclusion criteria (11 listed)
- Inability to undertake cycling exercise safely
- Use of prescribed anti-inflammatory medication
- Current smoker (or having quit <6months ago)
- Has a diagnosis of diabetes or other metabolic disorder
- Use of other medications that might interfere with study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet OnlyParticipants caloric intake will be reduced by 5000kcal per week over 4 weeks | Other | Diet Only |
| Diet plus ExerciseParticipants 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) | Other | Diet plus Exercise |
Primary outcome
Change in hsCRP
Time frame: 0, 4 and 8 weeks
Measured in mg/L via immunoassay
15 secondary outcomes
Other Systemic Biomarkers
Time frame: 0, 4 and 8 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 0, 4 and 8 weeks
EQ-5D-5L Health Questionnaire
Time frame: 0, 4 and 8 weeks
SF-36 Questionnaire
Time frame: 0, 4 and 8 weeks
Visual Analogue Scale (VAS) Pain
Time frame: 0, 4 and 8 weeks
30-second chair stand test
Time frame: 0, 4 and 8 weeks
40m fast paced walk
Time frame: 0, 4 and 8 weeks
Stair climb
Time frame: 0, 4 and 8 weeks
Timed up and go test
Time frame: 0, 4 and 8 weeks
Mechanical Detection Threshold
Time frame: 0, 4 and 8 weeks
Pressure Pain Threshold
Time frame: 0, 4 and 8 weeks
Body Mass Index
Time frame: 0, 4 and 8 weeks
Hip and Waist Circumference
Time frame: 0, 4 and 8 weeks
Body Composition
Time frame: 0, 4 and 8 weeks
Markers of metabolic health
Time frame: 0, 4 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 41759492Deere R, Farrow M, Spellanzon B, Chowdhury E, Thompson D, Bilzon JLJ. The effects of short-term dietary calorie restriction combined with aerobic exercise on systemic inflammation in overweight or obese individuals with knee osteoarthritis: a randomised controlled trial. Musculoskelet Sci Pract. 2026 Apr;82:103505. doi: 10.1016/j.msksp.2026.103505. Epub 2026 Feb 6.
- Individual participant dataSharing planned: No. Anonymous individual data for all outcomes may be made available.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Bilzon, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Only and Diet plus Exercise in people with Knee Osteoarthritis, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel L Deere, MSc (01225 385918, r.deere@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hsCRP (time frame: 0, 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.