LIfestyle INterventionS for PaIn ReliEf (INSPIRE)
- Conditions
- Osteoarthritis, Knee
- Interventions
- Dietary Supplement: Maltodextrin (Placebo)Behavioral: ExerciseDietary Supplement: Inulin Fibre supplement
- Registration Number
- NCT05670314
- Lead Sponsor
- University of Nottingham
- Brief Summary
This pilot study will be a placebo controlled randomised intervention study in which participants with knee pain will be grouped into the diet intervention, exercise intervention, diet and exercise intervention or placebo arm. The study involves intake of dietary supplements and performing routine exercises which are commonly used and are not pharmacological agents. The end-points of the study are non-clinical outcomes. N= 120. 2x2 intervention with 30 individuals per block: placebo, diet only, exercise only, diet + exercise
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
The participant may not enter the study if ANY of the following apply:
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm Maltodextrin (Placebo) The participants in the placebo/control arm (N=30) will be required to take 10g of maltodextrin for the same period of 6 weeks. Exercise only arm 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. 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. Diet + exercise intervention arm Inulin Fibre supplement The participants in this arm will be required to take 20g of inulin (N=30) for a period of 6 weeks and doing exercise at the same time. Diet only Arm Inulin Fibre supplement The participants in the dietary intervention arm will be required to take 20g of inulin (N=30) for a period of 6 weeks. Diet + exercise intervention arm Exercise The participants in this arm will be required to take 20g of inulin (N=30) for a period of 6 weeks and doing exercise at the same time.
- Primary Outcome Measures
Name Time Method Change in Numerical Rate Score (NRS) for pain Baseline and 6 weeks The Numerical Rate Score (NRS) will be used to assess the changes in the level of pain in response to the intervention between baseline and follow-up.
- Secondary Outcome Measures
Name Time Method Changes in serum Cytokines levels Baseline and 6 weeks Serum levels of cytokines will be measured using ELISA in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of pro and anti-inflammatory cytokines in response to the intervention.
Changes in serum Endocannabinoid levels Baseline and 6 weeks Serum levels of Endocannabinoids will be measured using mass spectrometry in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in levels of Endocannabinoids in response to the intervention.
Changes in DNA methylation on a subset of individuals Baseline and 6 weeks DNA methylation will be measured using specialized ELISA kits in samples collected at baseline and at follow-up (at the end of six weeks).
Changes in serum markers of immune phenotyping (PBMCs) Baseline and 6 weeks Serum levels of PBMCs will be measured using a multiplex technique in samples collected at baseline and at follow-up (at the end of six weeks). This will help us ascertain the change in immunological function in response to the intervention.
Changes in gut microbiome composition and short chain fatty acids Baseline and 6 weeks Changes in gut microbiome composition and serum levels of short-chain fatty acids (SCFAs) in response to the interventions. Gut microbiome composition will be measured using 16S sequencing on stool samples. SCFAs in serum will be measured using mass spectrometry.
Trial Locations
- Locations (1)
University of Nottingham
🇬🇧Nottingham, Nottinghamshire, United Kingdom