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Post Intensive Care Unit SyndromeIMPROVENCT05182086

Improving Recovery After Critical Illness

A study testing Group physical therapy and dietary improvements in people with Post Intensive Care Unit Syndrome and Critical Illness, run by Frisius Medisch Centrum at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Group physical therapy and dietary improvements
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteNetherlands
Study dates
1 Sep 2021to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Allergy to components of ProSource® (Allergy information: gluten-free, lactose-free, NOT cow's milk free (wey-protein), produced in a factory in which soy, wheat and nuts are processed.
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting
  • Medical Centre Leeuwarden

    Leeuwarden, 8934AD

    Lise Beumeler, lise.beumeler@mcl.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: IMPROVE: Evaluation of a Combined Lifestyle Intervention Program to Improve Quality of Life in Long-term ICU-survivors

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.

Read more

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.

Read the detailed 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.

Being tested
Group physical therapy and dietary improvements
Medical subject headings
Critical Illness, Malnutrition, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group physical therapy and dietary improvementsOther

    20 patients allocated to intervention group. During 12 weeks, patients will participate in a combined lifestyle intervention, including a one-hour physical therapist guided exercise group twice a week and consultation by a nutritional scientist. In case of inadequate intake, dietary supplements will be provided.

Study groups in NCT05182086
Study groupRoleWhat they receive
Intervention groupExperimentalPatients that are allocated to the intervention group will participate in a 12 week lifestyle intervention program consisting of group exercise therapy and dietary advice combined with dietary supplementation. The group exercise therapy will be guided by trained physical therapists. Patients will participate in this part of the intervention twice a week for one hour. The exercise therapy will combine cardiorespiratory with strength training. At the start of the intervention, patients will have an appointment with a nutritional scientist or doctor in which they will receive dietary advise and dietary supplements (ProSource®) to reach the advised caloric and protein intake as composed by the Dutch Centre for Nutrition (Voedingscentrum). Dietary supplements like ProSource® are extensively tested and often used as part of general practice to patients after ICU- or hospital-discharge following critical illness.
Receives: Other: Group physical therapy and dietary improvements
Standard careNo interventionStandard care outpatient post-ICU clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical functioning

    Physical functioning (subscale score) measured with the Dutch 36-Item Short Form health Survey/Research and Development-36 (RAND-36) questionnaire (0-100; higher is better)

    Measured: After the 12-week intervention program

Secondary outcomes (11)
  1. Change in hand grip strength

    Hand grip strength with hand-held dynamometer (kg; higher is better)

    Measured: Before and after the 12-week intervention program

  2. Change in walking distance

    Walking distance with the six-minute walking test (m, higher is better)

    Measured: Before and after the 12-week intervention program

  3. Change in quadriceps muscle layer thickness

    Ultrasound measures of the quadriceps (mm, higher is better)

    Measured: Before and after the 12-week intervention program

  4. Change in mobility

    Mobility using the morton mobility index (0-100, higher is better)

    Measured: Before and after the 12-week intervention program

  5. Change in dietary intake

    Dietary intake using food diary

    Measured: Before and after the 12-week intervention program

  6. Change in health-related quality of life

    Dutch 36-Item Short Form health Survey/Research and Development-36 (RAND-36) questionnaire (0-100; higher is better)

    Measured: Before and after the 12-week intervention program

  7. Change in fatigue

    Short Fatigue Questionnaire (Verkorte VermoeidheidsVragenlijst) (4-28, higher is worse)

    Measured: Before and after the 12-week intervention program

  8. Change in anxiety and depression symptoms

    Hospital Anxiety and Depression Scale (HADS) (0-21; higher is worse)

    Measured: Before and after the 12-week intervention program

  9. Change in cognitive functioning

    Cognitive Failure Questionnaire (CFQ) (0-100; higher is worse)

    Measured: Before and after the 12-week intervention program

  10. Change in subjective happiness

    Happiness Index (HI) VAS-scale (0-10; higher is better)

    Measured: Before and after the 12-week intervention program

  11. Phase angle

    Bioimpedence measurements

    Measured: Before and after the 12-week intervention program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start1 Sep 2021
  3. Primary completionDec 2024 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182086
Sponsor's protocol ID
RTPO 1103
Acronym
IMPROVE
Status last verified
Jan 2024
First submitted
31 Aug 2021
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Christiaanse PMR, van Zutphen T, Bolding HA, van der Werf RAM, Stellingwerf F, de Jager CM, Buter H, Boerma EC, Beumeler LFE. Effects of a Combined Lifestyle Intervention on Recovery of ICU Survivors: A Randomized Controlled Trial. Crit Care Med. 2026 Jun 1;54(6):1377-1386. doi: 10.1097/CCM.0000000000007095. Epub 2026 Mar 16.

    PubMed 41870216

Questions about this trial

What is this clinical trial studying?

A study testing Group physical therapy and dietary improvements in people with Post Intensive Care Unit Syndrome and Critical Illness, run by Frisius Medisch Centrum at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise Beumeler (058 286 6738, lise.beumeler@mcl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical functioning (time frame: After the 12-week intervention program). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05182086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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