Evaluation of the effects of a integrative lifestyle intervention program on health related quality of life after ICU-admission.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Post-intensive care syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical functioning (subscale score of the RAND-36) at the end of the 12 week
intervention period.
Secondary outcome
Hand grip strength test
Six-minute walking test
Ultrasound measurements of the quadriceps muscle
Morton mobility index
Dietary intake
Health-related quality of life (RAND-36, complete questionnaire)
Hospital Anxiety and Depression Scale (HADS)
Cognitive Failure Questionnaire (CFQ)
Happiness Index (HI)
All endpoints are assessed after the 12 week intervention period.
Background summary
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 and mental health,
reflecting in an impaired long-term recovery and decreased quality of life
(QoL). Long-term health problems can partly be contributed to prolonged muscle
weakness and malnutrition. 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, we hypothesize that a lifestyle intervention
program may improve wellbeing and quality of life in long-term ICU-survivors.
Study objective
Evaluation of the effects of a integrative lifestyle intervention program on
health related quality of life after ICU-admission.
Study design
Randomised controlled trial
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.
Study burden and risks
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. *
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
Long stay post-ICU patients (length of stay >=48h) between 6 weeks and 6 months
after hospital discharge
AND >18 years old
AND able to visit the hospital 2 times a week
AND a RAND-36 physical functioning subscale score < 67%
Exclusion criteria
- Allergy to components of ProSource®
- Inability to understand the Dutch language
- Actively participating in a professional physical rehabilitation program
during the study period. Note: previous participation in a concluded
rehabilitation program is NOT an exclusion criterion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL74913.099.20 |
Other | Onderzoek wordt geregistreerd na goedkeuring RTPO |