An interventional study of Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) in Cachexia and CKD, sponsored by Queen's University, Belfast. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Treatment
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). The investigators 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. The investigators will collect data on how successful the trial is (e.g., how many patients took part, completed all components of the study). Additionally, the investigators will collect data on physical functioning, muscle mass, body weight, quality of life and survival. After 12 weeks, the investigators will interview patients and clinicians to evaluate, if any, changes can be made to improve the intervention within what is called a 'process evaluation'.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's planned enrollment of 40 is below the median of 74 across 226 interventional studies indexed under Cachexia.
Browse Cachexia studies →Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individualised exercise programme: Participants will receive an exercise handbook and exercise diary to complete for a 12-week progressive home-based training programme (aerobic and resistance training). The intradialytic component will be an optional supervised 30-minute session up to 3 times per week. Dietary advice: Each patient in the intervention group will receive a 60-minute personalised dietetic assessment. Patients will be reviewed by the dietician at the start of the intervention and at 6-weeks and 12-weeks. Patients will also complete a 3-day food diary on five occasions throughout the 12 weeks of the interventions (weeks 1,3,6,9,12). Oral omega-3 supplement: Each patient will receive a 12-week supply of omega-3 oral capsules using a daily dose (1000mg twice daily) which has a proven safety profile, tolerability. Weekly contact: Patients in the intervention arm, will be contacted weekly (or more if preferred) by telephone. An adherence to MMIEAD log will be completed.
Other: Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD)
Patients in the control arm will not be offered the MMIEAD intervention. All study sites have been surveyed to ensure the intervention components are not provided in standard care. Patients who have been allocated to the control group will be advised to adhere to routine standard care throughout the study. As the recruitment sites cover four Trusts, a description of standard care per Trust will be collected as part of the process evaluation.
In addition to their standard care, the intervention group will receive MMIEAD - an individualised exercise programme, oral omega-3 supplementation and dietary advice.
Recruitment; measured as the number of fully enrolled patients as a proportion of approached eligible individuals
Time frame: From enrollment to the end of treatment at 12 weeks
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 75 non-industry interventional studies with no phase under Cachexia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 11 months is below that.
Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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