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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
Locations
Other Locations
Netherlands
Medical Centre Leeuwarden
RECRUITING
Leeuwarden
Contact Information
Primary
Lise Beumeler
lise.beumeler@mcl.nl
058 286 6738
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2025-03
Participants
Target number of participants: 40
Treatments
Experimental: Intervention group
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.
No_intervention: Standard care
Standard care outpatient post-ICU clinic
Related Therapeutic Areas
Sponsors
Collaborators: University Medical Center Groningen, University of Groningen
Leads: Frisius Medisch Centrum

This content was sourced from clinicaltrials.gov