Improving Recovery After Critical Illness

NCT05182086 | Unknown DMC

• 1 other identifier: RTPO 1103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Intensive Care Unit Syndrome; Critical Illness; Malnutrition; Muscle Weakness

Outcome Measures

Primary Outcomes (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)

  After the 12-week intervention program

Secondary Outcomes (11)

• Change in hand grip strength

  Before and after the 12-week intervention program

• Change in walking distance

  Before and after the 12-week intervention program

• Change in quadriceps muscle layer thickness

  Before and after the 12-week intervention program

• Change in mobility

  Before and after the 12-week intervention program

• Change in dietary intake

  Before and after the 12-week intervention program

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients 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.

Other: Group physical therapy and dietary improvements

Standard care

NO INTERVENTION

Standard care outpatient post-ICU clinic

Interventions

Group physical therapy and dietary improvements OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frisius Medisch Centrum: lead
• University of Groningen: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, 8934AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Critical Illness; Malnutrition; Muscle Weakness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Central Study Contacts

Lise Beumeler

CONTACT

058 286 6738; lise.beumeler@mcl.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: January 10, 2022
• Study Start: September 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

NL (1)