Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05182086 |
| Other study ID # |
RTPO 1103 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Medical Centre Leeuwarden |
| Contact |
Lise Beumeler |
| Phone |
058 286 6738 |
| Email |
lise.beumeler[@]mcl.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Rationale: Survival rates of patients with critical illness have increased due to improved
facilities and treatment methods in the intensive care unit (ICU). However, surviving
critical illness does not mean these patients are cured. In general, ICU-admission is
associated with decreased physical performance and perceived physical health, impaired mental
health and quality of life (QoL), reflecting in an impaired long-term recovery. Long-term
health problems can partly be contributed to prolonged muscle weakness and malnutrition.
Improving physical performance and perceived physical health may play a key role in boosting
recovery after ICU-admission. Mono-interventions focusing on improving physical performance
or nutritional intake have limited effect on long term functioning and QoL. A lifestyle
intervention encompassing physical therapy and optimisation of caloric and protein intake may
improve wellbeing and QoL in these patients. Previous studies found that interventions
focused on mobilization and physical rehabilitation are feasible within the ICU and
outpatient programs. Additionally, promising results were found in personalized healthcare
and lifestyle programs for other patient groups with long-term health problems, such as
cancer survivors and patients with diabetes or mental health problems. Based on this, the
investigators hypothesized that a lifestyle intervention program may improve wellbeing and
quality of life in long-term ICU-survivors.
Objective: Evaluation of the effects of a integrative lifestyle intervention program on
physical performance and perceived physical health, mental health and health related quality
of life after ICU-admission.
Study design: Randomised controlled trial Study population: Long-term ICU patients (length of
stay ICU ≥48h) Intervention: The intervention group will be part of a 12-week combined
lifestyle intervention encompassing group physical therapy twice a week and improvement of
dietary caloric and protein intake by means of nutritional advice and, if applicable, caloric
and/or protein supplementation. The control group will be subject to follow up meetings with
research staff to assess physical and mental health and quality of life.
Main study parameters/endpoints: Physical functioning (RAND-36 subscale-score) at the end of
the 12 week intervention period.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: All participants have two additional appointments where they participate in an
interview and perform physical tests (bioimpedance measurements, ultrasound of the upper
thigh muscles, hand grip strength test, Morton mobility index test, and the six-minute
walking test with pulse oximetry). At baseline and week 12 of the program, all participants
complete a combination of questionnaires on mental health and quality of life. The
intervention group will additionally be subject to supervised group training sessions twice a
week for the duration of the intervention (12 weeks). Further, two meetings with a
professional about their diet will be organised. If a patient has a deficit in caloric and/or
protein intake, dietary supplements with daily intake instructions will be provided. The
risks and disadvantages of this intervention are minimal. However, this study requires
considerable time investment and physical and mental effort. The extent of this study is
crucial to clarify the effect of a combined intervention program on recovery after critical
illness.
Description:
Survival rates of critical illness have increased due to improved facilities and treatment
methods in intensive care units. However, surviving critical illness does not automatically
mean these patients are cured. In the past, the patients' survival was the measure of success
in the treatment of critical illness. Over the past decades, the focus has been shifting
towards the quality of life and care needs of these patients after critical illness.
Survivors of critical illness frequently suffer from reduced quality of life. Health problems
in the recovery period of survivors may predominantly be provoked by the physical
consequences of longterm ICU-admission. The physical consequences of critical illness are
mostly associated with skeletal muscle wasting during critical illness. This results in a
decrease of muscle density up to two percent per day. Some long term physical health problems
associated with this phenomenon are fatigue, neuropathy, neuromuscular dysfunction, and
changes in bone mineral density. With regards to the long term psychosocial problems in
survivors of critical illness there have been reports of short and long-term anxiety,
depression and/or posttraumatic stress disorder (PTSD). Further, during and after critical
illness, patients may experience delirium and cognitive impairments. In conclusion, survivors
of critical illness suffer from long term physical and mental health problems, reflecting in
a reduced HRQoL.
Critical illness survivorship is a relatively new and unknown area in research and medical
health care. The term post-intensive care syndrome (PICS) has been used to describe the
complex aetiology of health deficits following critical illness. A recent Dutch study (the
MONITOR-IC-study) with a population of 1729 ICU-patients found that an overwhelming 70
percent of ICU-patients suffer from some form of PICS one year after discharge. Data
collected from the specialized post-ICU clinic of the Medical Centre Leeuwarden (MCL)
illustrated that 44% of 250 patients that visited this clinic between 2012 and 2018 were
unable to sufficiently recover in physical functioning one year after ICU-discharge.
Unfortunately, adequate and efficient aftercare programs for ICU survivors are still lacking
and patients regularly feel abandoned and insecure after discharge. Personalised healthcare
and lifestyle interventions may fulfil this discontinuity in care and improve physical
performance and perceived physical health in ICU-patients, followed by improvements in mental
wellbeing and HRQoL. Little is known on the effects of optimizing lifestyle on longterm
recovery of these patients. Promising results were found in personalised healthcare and
lifestyle programs for other patient groups with long-term health problems, such as cancer
survivors and patients with diabetes or mental health problems. A Cochrane review showed
several exercise rehabilitation programs after ICU-discharge to be feasible, but lacking in
overall effect on functional exercise capacity, or on health-related quality of life. This
paucity of effect on patient-centred outcomes may be due to inconsistencies in study
protocol. However, a lack of adequate nutritional support might be an equally important
pitfall. ICU-survivors may experience a number of problems that can hinder their nutritional
intake, including lack of appetite, problems with taste and smell perception, and swallowing
issues. Recent data from a study on post-ICU nutritional intake showed that of 12 included
patients, the majority did not meet their daily caloric and protein intake. Data on
nutritional intake after hospital discharge is lacking, but it is likely that patients are
unable to achieve these goals without professional support.
Based on this, the investigators hypothesized that, complementary to the standard post-ICU
care, a combined lifestyle intervention focussed on exercise and nutritional therapy may
improve physical performance and perceived physical health alongside with an improved mental
wellbeing and quality of life in long-term ICU-survivors.
