SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy

Not Applicable

Terminated

• Conditions: Liver Cirrhosis, Alcoholic
• Interventions: Behavioral: Supervised exercise; Behavioral: SMS-messages; Other: Usual Care

• Registration Number: NCT02811887
• Lead Sponsor: Marius Henriksen

Brief Summary

To investigate whether simple reminders about healthy lifestyle sent via mobile phone text messages can improve the liver cirrhosis severity and prognosis (as assessed by the MELD score supported by the Child-Pugh score) among patients with liver cirrhosis that have been through a 12-week supervised and facility-based physical exercise training program and in-patient rehabilitation.

Detailed Description

Physical exercise and other interventions focused on lifestyle factors have not only the potential to increase physical functioning and capacity, but also to affect fundamental aspects of disease, increase quality of life, and may even increase survival in patients with liver cirrhosis.

Instruction and advice about a healthy lifestyle and physical activity are attractive as it limits time spent on supervised rehabilitation at an outpatient clinic. Further, self-management can be attractive to society as it can conserve health care resources. However, instructions and advice can only be effective if the patients adhere to them, and there is a need for initiatives that enhance the motivation to follow the advice and change undesirable behaviours.

Mobile phone short-message service (SMS) messages are increasingly used to deliver interventions and enhance healthy behaviour. The technology is simple, cost-effective, can be automated, and can reach any mobile phone owner. In a recent systematic review, SMS-messages have been shown effective in a broad range of healthy behaviours, which was also highlighted in a randomized trial showing positive effects of lifestyle-focused SMS-messages on cardiovascular risk factors in patients with coronary heart disease. An SMS-message-based lifestyle intervention therefore seems like a feasible and effective means of enhancing motivation to follow advice about healthy lifestyle and physical activity among patients with liver cirrhosis.

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-23
• Study Start: 2016-08
• Primary Completion: 2019-10
• Study Completion: 2019-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Adult, i.e. age 18 years or above.
2. Is attending the liver cirrhosis rehabilitation clinic at Bispebjerg hospital; i.e., has alcohol-induced liver cirrhosis or hepatorenal syndrome and has at least once experienced severe decompensation in the form of hepatic encephalopathy or variceal haemorrhage.
3. Has attended at least 50% of the scheduled sessions in the 12 week run-in physical exercise program
4. Is the owner of a mobile phone capable of receiving SMS-messages
5. Has signed informed consent
6. Reads and speaks Danish

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Exclusion Criteria

1. Any condition that in the opinion of the investigator puts an otherwise eligible participant at increased risk by participation or otherwise make the person unfit for participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Supervised exercise	12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic
SMS-messages	SMS-messages	12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic + regular text messages via SMS over a 12-week period
SMS-messages	Supervised exercise	12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic + regular text messages via SMS over a 12-week period
Usual care	Usual Care	12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic

Primary Outcome Measures

Name	Time	Method
Change in The Model for End-Stage Liver Disease (MELD) score	week -12, 0, 12, 24	The MELD is a reliable measure of mortality risk in patients with end-stage liver disease. The MELD is based on a mathematical equation.; The MELD score is calculated using the following formula: MELD Score = 9.57 x ln (creatinine mg/dL) + 3.78 x ln(bilirubin mg/dL) + 11.2 x ln(INR)+ 6.43

Secondary Outcome Measures

Name	Time	Method
SOKRATES questionnaire	week -12, 0, 12, 24	SOKRATES8a is a standardised patient-reported instrument for use as a measure of readiness for change in alcohol abusers
Sickness Impact Profile (SIP) questionnaire	week -12, 0, 12, 24	The Sickness Impact Profile (SIP) questionnaire is a 136 items generic health status measure
Plasma concentrations of inflammatory markers	week -12, -6, 0	EDTA plasma will be collected at before and after 12 weeks of supervised training intervention, and before and after a single exercise session in week 6 to analyse specific for cytokines/myokines interactions e.g. TNF alfa and IL-6.
Quality of life, SF-36v1	week -12, 0, 12, 24	10.2.2.1 Quality of life, SF-36v1 Short Form-36v1 is a standardised patient-reported instrument for use as a measure of health outcome and quality of life
10.2.1.1 Child-Pugh score	week -12, 0, 12, 24
30-seconds chair stand test	week -12, 0, 12, 24	The 30-seconds chair stand test (30-s CST) is performed in an undisturbed room with hands crossed against the chest. It is one of the most important functional evaluation clinical tests because it measures lower body strength and relates it to the most demanding daily life activities. A 30-s CST consists of standing up and sitting down from a chair as many times as possible within 30 seconds.
Six-Minute Walk Test	week -12, 0, 12, 24	The Six-Minute Walk-Test (6MWT) assesses general physical function. The test is performed in an undisturbed hospital corridor marked every 2 meters with coloured tape on the floor; starting and turning points marked by cones. Subjects are instructed to walk as fast as they can. They are allowed to stop or rest during the test if necessary and walking aids are allowed. The distance in meters covered during the 6 minutes is the outcome of the test.
Muscle Power	week -12, 0, 12, 24	The Leg Extensor Power Rig will be used to measure muscle power (force x velocity) in a non-invasive way. The participants will be in a seated position and a single explosive limb extension will accelerate a flywheel from rest. The participants will be instructed to kick the pedal as hard and fast as possible. Repeated kicks are performed, until a significant decline in power is observed. The kick with maximal power is the result of the text, and is recorded in Watts.
Standard blood sample	week -12, 0, 12, 24	As part of the usual assessment of the patients, standard blood samples (15ml) are drawn and analysed (4 visits x 15 ml = 60 ml per participant). The analyses include: Haemoglobin (Hgb), white blood cells, Bilirubin, ALAT, ASAT, INR, platelets, CRP, creatinine, urea, sodium, potassium, alkaline phosphatase albumin, coagulations factors II VII and X.

Trial Locations

Locations (1)

Bispebjerg Hospital, Department of Physical and Occupational Therapy; 🇩🇰 Copenhagen, Denmark