MMIEAD cRCT for renal cachexia

  • Research type

    Research Study

  • Full title

    Multi-Modal Integrative intervention combining Exercise, Anti-inflammatory & Dietary advice (MMIEAD) for kidney cachexia: a mixed-methods feasibility cluster randomised controlled trial and process evaluation.

  • IRAS ID

    354529

  • Contact name

    Joanne Reid

  • Contact email

    j.reid@qub.ac.uk

  • Sponsor organisation

    Queen’s University Belfast

  • Clinicaltrials.gov Identifier

    NCT07107087

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Lay abstract
    Patients with kidney cachexia will experience extreme muscle loss, reduced strength and symptoms including fatigue, reduced appetite and lower quality of life. Patients are also at an increased risk of hospitalization and shortened life expectancy. Previous research suggests that treatments that target several causes of the muscle wasting syndrome (known as cachexia), show better outcomes for patients than treatments using just one method (for example only exercise). We want to see if combining different treatments (exercise, dietary advice and anti-inflammatory supplements) will improve outcomes for patients with kidney failure receiving hemodialysis at risk of developing kidney cachexia, compared to patients who only receive routine kidney care alone. Combined treatments which include anti-inflammatory supplements (including those found in fish oils), alongside exercise and dietary advice, have been successfully trialed in other chronic illnesses, such as cancer for the treatment of cachexia. However, these three treatments have not been tested together in patients with kidney cachexia.

    Patients at risk of kidney cachexia who are receiving haemodialysis at two renal departments (BHSCT and NHSCT) have been assigned to the treatment group (Multi-Modal Integrated intervention combining Exercise, Anti-inflammatory & Dietary advice plus routine care) and one (SEHSCT) has been assigned to the control group (routine care). Over 12 weeks, those in the treatment group will receive an individualised exercise programme, dietary advice and anti-inflammatory (fish oil) nutritional supplements. We will collect data on how successful the trial is (e.g., how many patients took part, completed all components of the study). Additionally, we will collect data on physical functioning, muscle mass, body weight, quality of life and survival. After 12 weeks, we will interview patients and clinicians to evaluate, if any, changes can be made to improve the intervention within what is called a ‘process evaluation’.

  • REC name

    HSC REC A

  • REC reference

    25/NI/0069

  • Date of REC Opinion

    23 Jun 2025

  • REC opinion

    Further Information Favourable Opinion