Effect of Energy Restriction and Exercise for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Effect of Short-term Negative Energy Balance With or Without Exercise on Systemic Biomarkers in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518890
• Other study ID #: 20/SW/0063
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2022
• Source: University of Bath
• Contact: Rachel L Deere, MSc
• Phone: 01225 385918
• Email: r.deere[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 will be randomised into either the diet alone group or the diet plus exercise group.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Diet Only
Participants caloric intake will be reduced by 5000kcal per week over 4 weeks
• Diet plus Exercise
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)

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath

Sponsors (2)

Lead Sponsor	Collaborator
University of Bath	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hsCRP	Measured in mg/L via immunoassay	0, 4 and 8 weeks
Secondary	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	0, 4 and 8 weeks
Secondary	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.	0, 4 and 8 weeks
Secondary	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.	0, 4 and 8 weeks
Secondary	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.	0, 4 and 8 weeks
Secondary	Visual Analogue Scale (VAS) Pain	0-10 scale Higher scores indicate worse pain	0, 4 and 8 weeks
Secondary	30-second chair stand test	Repetitions	0, 4 and 8 weeks
Secondary	40m fast paced walk	meters/second	0, 4 and 8 weeks
Secondary	Stair climb	seconds	0, 4 and 8 weeks
Secondary	Timed up and go test	seconds	0, 4 and 8 weeks
Secondary	Mechanical Detection Threshold	millinewtons (mN)	0, 4 and 8 weeks
Secondary	Pressure Pain Threshold	Newtons (N)	0, 4 and 8 weeks
Secondary	Body Mass Index	kg/m2	0, 4 and 8 weeks
Secondary	Hip and Waist Circumference	centimetres	0, 4 and 8 weeks
Secondary	Body Composition	Change in body composition via Dual Energy XX-Ray Absorptiometry scan	0, 4 and 8 weeks
Secondary	Markers of metabolic health	mmol/L; Glucose; Non-Esterified Fatty Acids; Triglycerides; Total cholesterol; Low Density Lipoprotein Cholesterol; High Density Lipoprotein Cholesterol	0, 4 and 8 weeks