NCT07107087

A Cluster Randomised Controlled Trial of a Multimodal Integrated Intervention for Kidney Cachexia

Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) for Kidney Cachexia: a Mixed-methods Feasibility Cluster Randomised Controlled Trial and Process Evaluation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Queen's University, Belfast · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This lay description has been written in conjunction with, and the content approved by our Patient and Public Involvement collaborators. 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 hospitalisation 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 haemodialysis at risk of developing kidney cachexia, compared to patients who only receive routine kidney care alone. However, there is currently no routine treatment for kidney cachexia. Individual treatments, such as exercise, have not been successful to slow the progression of wasting in chronic diseases. Our recent review of scientific literature highlighted dual treatments of exercise and dietary advice is effective to varying degrees. Combined treatments which include anti-inflammatory supplements (including those found in fish oils), alongside exercise and dietary advice, have been successfully trialled in other chronic illnesses, such as cancer for the treatment of cachexia. However, this bundle of three treatments has not been tested in patients with kidney cachexia. It is important to test whether such a combination of treatments will be practical for patients and clinicians. Our study will assess how well this intervention works in the healthcare system and if it shows potential to help patients with kidney cachexia. Patients at risk of kidney cachexia who are receiving haemodialysis at two renal departments have been assigned to the treatment group (Multi-Modal Integrated intervention combining Exercise, Anti-inflammatory \& Dietary advice plus routine care) and two have 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'.

Conditions

• Cachexia
• CKD

Interventions

Type	Name	Description
OTHER	Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD)	In addition to their standard care, the intervention group will receive MMIEAD - an individualised exercise programme, oral omega-3 supplementation and dietary advice.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-08-06
• Last updated: 2025-08-06