Clinical trial NCT05831982: Exercise and Nutrition Intervention for Frail Older Patients
Official title: The Effect of a Complex Person-centered Exercise and Nutrition Intervention for Frail Older Patients on Functional Decline, Quality of Life and Readmissions - A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: older
frailty
strength training
nutrition
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 119
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effect of a person-centered training and nutrition intervention six month after discharge in acutely admitted frail old medical patients on physical function. Secondly, to evaluate the effect on frailty, quality of life, health literacy, nutrition, readmissions, death and consumption of home care costs.

Detailed description: Evidence on how to improve physical function and avoid unnecessary readmissions for frail hospitalized older medical patients is not established as yet. In Denmark, the few studies performed have not succeeded in showing a significant difference in physical function or quality of life, due to sector barriers, low compliance and uni-dimensional interventions and none of the studies addressed readmissions and or described a patient-centered approach.

This research project will address this serious individual and societal challenge by testing and evaluating a person-centered complex intervention with emphasis on the patients´ own focus and goals. To increase the probability of developing a successful intervention with the patient in focus we have completed two qualitative studies with patients and health professionals. The primary results from these studies indicate that the pedagogical approach of the involved healthcare professional is important for establishing a good relation. Patients had a desire of being more active, but after four week only a minority had their own expectations fulfilled. Furthermore, the patients expressed that social relations had the potential of increasing adherence to training sessions. Furthermore, a citizen's panel has been established, and possible elements important for the intervention were discussed on behalf of their own experiences with the healthcare system. The results of these qualitative studies and the latest evidence contributed to the development of the current intervention study.

Eligibility criteria: Inclusion Criteria:

* 65+ years old
* Acutely admitted with a medical focus at Aalborg University Hospital, South.
* Living in Aalborg Municipality (except 9230 Svenstrup, 9240 Nibe, 9293 Kongerslev, 9381 Sulsted, and 9382 Tylstrup)
* Able to walk (assistance is ok) before admission.
* Speak and understand Danish.

Exclusion Criteria:

* Discharged with rehabilitatinplan for physiotherapy within the last 30 days.
* Dementia or other cognitive impairments.
* Terminal ill.

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: 26 weeks
Secondary outcomes:
measure: Timed Up and Go
timeFrame: 26 weeks
measure: Timed Up and Go
timeFrame: 15 weeks
measure: Grip strength
timeFrame: 26 weeks
measure: Grip strength
timeFrame: 15 weeks
measure: Tilburg Frailty Indicator
timeFrame: 26 weeks
measure: Tilburg Frailty Indicator
timeFrame: 15 weeks
measure: Clinical Frailty Scale (CFS)
timeFrame: 26 weeks
measure: Clinical Frailty Scale (CFS)
timeFrame: 15 weeks
measure: EQ5D-5L
timeFrame: 26 weeks
measure: EQ5D-5L
timeFrame: 15 weeks
measure: Body mass, body fat mass and body muscle mass
timeFrame: 26 weeks
measure: Body mass, body fat mass and body muscle mass
timeFrame: 15 weeks
measure: Admission
timeFrame: 26 weeks.
measure: Admission
timeFrame: 15 weeks.
measure: Home care
timeFrame: 26 weeks.
measure: Home care
timeFrame: 15 weeks.
measure: Other healthcare services
timeFrame: 26 weeks.
measure: Short Physical Performance Battery (SPPB)
timeFrame: 15 weeks
measure: Height
timeFrame: Baseline
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Municipality
Study officials:
affiliation: Aalborg University Hospital
name: Laurine Nilsson, PhD stud.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital and Aalborg Municipality
name: Jane Andreasen, Assoc. prof.
role: STUDY_CHAIR
affiliation: Aalborg University Hospital and Aalborg University
name: Mette Holst
role: STUDY_CHAIR
affiliation: Aarhus Municipality, Denmark
name: Morten Villumsen
role: STUDY_CHAIR
References:
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
citation: Rossi PG, Carnavale BF, Farche ACS, Ansai JH, de Andrade LP, Takahashi ACM. Effects of physical exercise on the cognition of older adults with frailty syndrome: A systematic review and meta-analysis of randomized trials. Arch Gerontol Geriatr. 2021 Mar-Apr;93:104322. doi: 10.1016/j.archger.2020.104322. Epub 2020 Dec 10.
citation: Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review. Clin Interv Aging. 2017 May 24;12:873-896. doi: 10.2147/CIA.S130794. eCollection 2017.
citation: Andreasen J, Aadahl M, Sorensen EE, Eriksen HH, Lund H, Overvad K. Associations and predictions of readmission or death in acutely admitted older medical patients using self-reported frailty and functional measures. A Danish cohort study. Arch Gerontol Geriatr. 2018 May-Jun;76:65-72. doi: 10.1016/j.archger.2018.01.013. Epub 2018 Feb 13.
citation: Nilsson L, Holst M, Villumsen M, Andreasen J. Maintenance of own health after acute hospitalization - older people's experiences and perspectives on physical activity and nutrition. Physiother Theory Pract. 2024 Jan 2;40(1):100-109. doi: 10.1080/09593985.2022.2122912. Epub 2022 Oct 3.
citation: Rasmussen RL, Holst M, Nielsen L, Villumsen M, Andreasen J. The perspectives of health professionals in Denmark on physical exercise and nutritional interventions for acutely admitted frail older people during and after hospitalisation. Health Soc Care Community. 2020 Nov;28(6):2140-2149. doi: 10.1111/hsc.13025. Epub 2020 Jun 1.
citation: Baert V, Gorus E, Mets T, Geerts C, Bautmans I. Motivators and barriers for physical activity in the oldest old: a systematic review. Ageing Res Rev. 2011 Sep;10(4):464-74. doi: 10.1016/j.arr.2011.04.001. Epub 2011 May 5.