Nutritional management in motor neuron disease Nervous System Diseases Motor neuron disease
Conditions
Interventions
Participants will be randomly assigned to the control group or the intervention group. The control group will continue to receive their usual care, and be restricted to only completing food diaries on
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/06/2024: 1. Age 18 years or older 2. Diagnosis of clinically definite, lab supported, clinically probable, or possible ALS by the Gold Coast criteria and additionally the PMA variant where appropriate investigation has excluded mimics of motor neuron disease 3. Within 2.5 years of onset of first muscle weakness 4. Stabilised on riluzole for 1 month or not on riluzole Previous inclusion criteria: 1. Age 18 years or older 2. Diagnosis of clinically definite, lab supported, clinically probable, or possible ALS by the El-Escorial criteria and additionally the PMA variant where appropriate investigation has excluded mimics of motor neuron disease 3. Within 2 years of onset of first muscle weakness 4. Stabilised on riluzole for 1 month or not on riluzole
Exclusion criteria
Exclusion criteria: 1. Co-morbidity that would affect survival or metabolic state (e.g. unstable thyroid disease or unstable diabetes mellitus) 2. BMI >=35kg/m² 3. Lacking capacity to provide fully informed written consent, verbal consent (for those who cannot provide written consent), or consent via the use of a communication aid. 4. Previous participation in the HighCALS PGfAR research programme 5. Unable to understand written and spoken English 6. Using a gastrostomy tube for feeding (those using a gastrostomy tube for fluid or medication are not excluded)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily functional abilities will be assessed using the The Amyotrophic Lateral Sclerosis Rating Scale (ALSFRSR), a validated rating scale. This will be assessed at baseline, month1, 3, 6, 9 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.CAFS, calculated using survival and ALSFRSR scores, at baseline, month 1, 3, 6, 9 and 12 2. Quality of life via WHOQOL-BREF questionnaire at baseline, month 1, 3, 6, 9 and 12 3. Health status via EQ-5D-3L questionnaire at baseline, month 1, 3, 6, 9 and 12 4. Total calorie intake using food diaries at week 1, month 1, 3, 6, 9 and 12 5. Healthcare resource use questionnaire at baseline, month 3, 6, 9 and 12 6. Adverse events at month 1, 3, 6, 9 and 12 7. Slow vital capacity / FEV6 using spirometer at baseline, month 1, 3, 6, 9 and 12 8. Mid arm circumference at baseline, month 1, 3, 6, 9 and 12 9. Triceps skin fold thickness at baseline, month 1, 3, 6, 9 and 12 10. Calf circumference at baseline, month 1, 3, 6, 9 and 12 11. Weight measured at baseline, month 1, 3, 6, 9 and 12 12. Height measured at baseline, month 1, 3, 6, 9 and 12 13. Acceptability of intervention questionnaire at months 3 and 12 14. Overall survival at months 1, 3, 6, 9, 12 and last patient/last visit 15. Fasting lipids via blood sample at baseline, month 1,3,6,9 and 12 16. Albumin via blood sample at baseline, month 1,3,6,9 and 12 17. Lactate via blood sample at baseline, month 1,3,6,9 and 12 18. Renal function via blood sample at baseline, month 1,3,6,9 and 12 19. Creatinine via blood sample at baseline, month 1,3,6,9 and 12 20. C-reactive protein via blood sample at baseline, month 1,3,6,9 and 12 21. Neurofilament serum via blood sample at baseline, months 6 and 12 22. HbA1c via blood sample at baseline, month 1,3,6,9 and 12 23. Thyroid function via blood sample at baseline | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactElaine;Gemma Scott;Hackney
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Outcome results
None listed