lIfestyle iNterventionS for PaIn ReliEf (INSPIRE)

University of Nottingham

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Dietary Supplement: Maltodextrin (Placebo); Dietary Supplement: Inulin Fibre supplement; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05670314

22025

Details and patient eligibility

About

This is a 2x2 factorial design randomised controlled trial 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. N= 117. 2x2 intervention with individuals per block: placebo (n=27), diet only (n=26), exercise only (n=40), diet + exercise (n=24)

Enrollment: 117 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants with any pain in or around a knee on most days for more than 3 months
• 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

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 4 patient groups, including a placebo group

Placebo arm

Placebo Comparator group

Description:

The participants in the placebo/control arm will be required to take 10g of maltodextrin for the same period of 6 weeks.

Treatment:

Dietary Supplement: Maltodextrin (Placebo)

Diet only Arm

Experimental group

Description:

The participants in the dietary intervention arm will be required to take 20g of inulin for a period of 6 weeks.

Treatment:

Dietary Supplement: Inulin Fibre supplement

Exercise only arm

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Diet + exercise intervention arm

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Dietary Supplement: Inulin Fibre supplement