Effect of Energy Restriction and Exercise for Knee Osteoarthritis

NCT05518890 | Unknown

• 1 other identifier: 20/SW/0063
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in hsCRP

  Measured in mg/L via immunoassay

  0, 4 and 8 weeks

Secondary Outcomes (15)

• Other Systemic Biomarkers

  0, 4 and 8 weeks

• The Knee Injury and Osteoarthritis Outcome Score (KOOS)

  0, 4 and 8 weeks

• EQ-5D-5L Health Questionnaire

  0, 4 and 8 weeks

• SF-36 Questionnaire

  0, 4 and 8 weeks

• Visual Analogue Scale (VAS) Pain

  0, 4 and 8 weeks

Study Arms (2)

Diet Only

EXPERIMENTAL

Reduced calorie intake by 5000kcals per week over a 4 week period

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.

Other: Diet plus Exercise

Interventions

Diet Only OTHER

Participants caloric intake will be reduced by 5000kcal per week over 4 weeks

Diet Only

Diet plus Exercise OTHER

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)

Diet plus Exercise

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• University of Oxford: collaborator

Study Sites (1)

University of Bath

Bath, BA27AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Bilzon, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel L Deere, MSc

CONTACT

01225 385918; r.deere@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor James Bilzon

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: August 29, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)