Study Results
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View full resultsBasic Information
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COMPLETED
NA
117 participants
INTERVENTIONAL
2022-05-01
2025-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo arm
The participants in the placebo/control arm will be required to take 10g of maltodextrin for the same period of 6 weeks.
Maltodextrin (Placebo)
10g/ day which can be consumed by adding to breakfast cereal/ smoothie/ yogurt or drink of choice
Diet only Arm
The participants in the dietary intervention arm will be required to take 20g of inulin for a period of 6 weeks.
Inulin Fibre supplement
20g/ day. Inulin is easily dissolvable in liquid and can be incorporated into the usual diet - by adding to water, juice, smoothies, cereal, yogurt etc.
Exercise only arm
Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises. The intervention also includes educational sessions integrated into the programme covering the basics of OA, its treatment, self-managing symptoms of OA and the benefits of maintaining a healthy lifestyle. The exercise intervention focuses on core stability and performance, neuromuscular leg strengthening and balance enhancement.
Exercise
Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises.
Diet + exercise intervention arm
The participants in this arm will be required to take 20g of inulin for a period of 6 weeks and doing exercise at the same time.
Inulin Fibre supplement
20g/ day. Inulin is easily dissolvable in liquid and can be incorporated into the usual diet - by adding to water, juice, smoothies, cereal, yogurt etc.
Exercise
Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises.
Interventions
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Inulin Fibre supplement
20g/ day. Inulin is easily dissolvable in liquid and can be incorporated into the usual diet - by adding to water, juice, smoothies, cereal, yogurt etc.
Maltodextrin (Placebo)
10g/ day which can be consumed by adding to breakfast cereal/ smoothie/ yogurt or drink of choice
Exercise
Joint Academy An app-based exercises platform (Joint Academy®) will be used as an intervention given to the treatment arm. The programme consists of a mixture of open and close chain exercises, a combination of concentric, eccentric and focusing on the global strength of legs including the muscles around the hips and knee joints as well as balance enhancement exercises.
Eligibility Criteria
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Inclusion Criteria
* Participant is willing and able to give informed consent for participation in the study
* Participant eligibility includes those aged \>18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2
Exclusion Criteria
* Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
* Are taking the following medications: immunosuppressants, anticoagulants, amiodarone and/or perhexiline
* Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
* Pregnant or breast feeding
* History or current psychiatric illness
* History or current neurological condition (e.g. epilepsy)
* Those undergoing revision, having severe hip OA, inflammatory arthropathies
* Diagnosed non-OA cause of knee pain (e.g. rheumatoid arthritis)
* Neuropathy or diabetes mellitus
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)
19 Years
ALL
Yes
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Ana Valdes, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor in Genetic and Molecular Epidemiology
Locations
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University of Nottingham
Nottingham, Nottinghamshire, United Kingdom
Countries
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References
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Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.
Yu D, Peat G, Bedson J, Jordan KP. Annual consultation incidence of osteoarthritis estimated from population-based health care data in England. Rheumatology (Oxford). 2015 Nov;54(11):2051-60. doi: 10.1093/rheumatology/kev231. Epub 2015 Jul 9.
Moseng T, Vliet Vlieland TPM, Battista S, Beckwee D, Boyadzhieva V, Conaghan PG, Costa D, Doherty M, Finney AG, Georgiev T, Gobbo M, Kennedy N, Kjeken I, Kroon FPB, Lohmander LS, Lund H, Mallen CD, Pavelka K, Pitsillidou IA, Rayman MP, Tveter AT, Vriezekolk JE, Wiek D, Zanoli G, Osteras N. EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis: 2023 update. Ann Rheum Dis. 2024 May 15;83(6):730-740. doi: 10.1136/ard-2023-225041.
Jonsson T, Eek F, Dell'Isola A, Dahlberg LE, Ekvall Hansson E. The Better Management of Patients with Osteoarthritis Program: Outcomes after evidence-based education and exercise delivered nationwide in Sweden. PLoS One. 2019 Sep 19;14(9):e0222657. doi: 10.1371/journal.pone.0222657. eCollection 2019.
Gohir SA, Eek F, Kelly A, Abhishek A, Valdes AM. Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis: The iBEAT-OA Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210012. doi: 10.1001/jamanetworkopen.2021.0012.
Zhang S, Wang D, Zhao J, Zhao H, Xie P, Zheng L, Sheng P, Yuan J, Xia B, Wei F, Zhang Z. Metabolic syndrome increases osteoarthritis risk: findings from the UK Biobank prospective cohort study. BMC Public Health. 2024 Jan 19;24(1):233. doi: 10.1186/s12889-024-17682-z.
Brain K, Burrows TL, Rollo ME, Chai LK, Clarke ED, Hayes C, Hodson FJ, Collins CE. A systematic review and meta-analysis of nutrition interventions for chronic noncancer pain. J Hum Nutr Diet. 2019 Apr;32(2):198-225. doi: 10.1111/jhn.12601. Epub 2018 Oct 7.
Fortuna R, Wang W, Mayengbam S, Tuplin EWN, Sampsell K, Sharkey KA, Hart DA, Reimer RA. Effect of prebiotic fiber on physical function and gut microbiota in adults, mostly women, with knee osteoarthritis and obesity: a randomized controlled trial. Eur J Nutr. 2024 Sep;63(6):2149-2161. doi: 10.1007/s00394-024-03415-w. Epub 2024 May 7.
Woodhams SG, Sagar DR, Burston JJ, Chapman V. The role of the endocannabinoid system in pain. Handb Exp Pharmacol. 2015;227:119-43. doi: 10.1007/978-3-662-46450-2_7.
Ding W, You Z, Chen Q, Yang L, Doheny J, Zhou X, Li N, Wang S, Hu K, Chen L, Xia S, Wu X, Wang C, Zhang C, Chen L, Ritchie C, Huang P, Mao J, Shen S. Gut Microbiota Influences Neuropathic Pain Through Modulating Proinflammatory and Anti-inflammatory T Cells. Anesth Analg. 2021 Apr 1;132(4):1146-1155. doi: 10.1213/ANE.0000000000005155.
Millar B, McWilliams DF, Abhishek A, Akin-Akinyosoye K, Auer DP, Chapman V, Doherty M, Ferguson E, Gladman JRF, Greenhaff P, Stocks J, Valdes AM, Walsh DA. Investigating musculoskeletal health and wellbeing; a cohort study protocol. BMC Musculoskelet Disord. 2020 Mar 21;21(1):182. doi: 10.1186/s12891-020-03195-4.
Karandikar N, Vargas OO. Kinetic chains: a review of the concept and its clinical applications. PM R. 2011 Aug;3(8):739-45. doi: 10.1016/j.pmrj.2011.02.021.
Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.
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Arant KR, Katz JN, Neogi T. Quantitative sensory testing: identifying pain characteristics in patients with osteoarthritis. Osteoarthritis Cartilage. 2022 Jan;30(1):17-31. doi: 10.1016/j.joca.2021.09.011. Epub 2021 Sep 28.
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Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better Management of Patients with Osteoarthritis: Development and Nationwide Implementation of an Evidence-Based Supported Osteoarthritis Self-Management Programme. Musculoskeletal Care. 2015 Jun;13(2):67-75. doi: 10.1002/msc.1085. Epub 2014 Oct 24.
Luan L, El-Ansary D, Adams R, Wu S, Han J. Knee osteoarthritis pain and stretching exercises: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:16-29. doi: 10.1016/j.physio.2021.10.001. Epub 2021 Oct 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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22025
Identifier Type: -
Identifier Source: org_study_id
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