Exercise and Nutrition Intervention for Frail Older Patients

Frailty Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05831982
• Other study ID #: 2021-215
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Person-centered strength training and nutrition intervention
Focus on high intensity strength training and nutrition intervention with focus on energy and protein intake. Focus on social relations
• Standard training
Training as usual when discharged with a rehabilitation plan.

Locations

Country	Name	City	State
Denmark	Aalborg Municipality	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery (SPPB)	A group of measures that combines the results of the gait speed, chair stand and balance tests	26 weeks
Secondary	Timed Up and Go	A simple test used to assess a person's mobility and requires both static and dynamic balance.	26 weeks
Secondary	Timed Up and Go	A simple test used to assess a person's mobility and requires both static and dynamic balance.	15 weeks
Secondary	Grip strength	Measures the muscular strength or the maximum force generated using a hand held dynamometer	26 weeks
Secondary	Grip strength	Measures the muscular strength or the maximum force generated using a hand held dynamometer	15 weeks
Secondary	Tilburg Frailty Indicator	The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people	26 weeks
Secondary	Tilburg Frailty Indicator	The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people	15 weeks
Secondary	Clinical Frailty Scale (CFS)	The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill)	26 weeks
Secondary	Clinical Frailty Scale (CFS)	The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill)	15 weeks
Secondary	EQ5D-5L	A descriptive system which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health)	26 weeks
Secondary	EQ5D-5L	A descriptive system which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health)	15 weeks
Secondary	Body mass, body fat mass and body muscle mass	Inbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.	26 weeks
Secondary	Body mass, body fat mass and body muscle mass	Inbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.	15 weeks
Secondary	Admission	Number of admissions	26 weeks.
Secondary	Admission	Number of admissions	15 weeks.
Secondary	Home care	Hours of home care	26 weeks.
Secondary	Home care	Hours of home care	15 weeks.
Secondary	Other healthcare services	ex. Occupational therapy or psychologist	26 weeks.
Secondary	Short Physical Performance Battery (SPPB)	A group of measures that combines the results of the gait speed, chair stand and balance tests	15 weeks
Secondary	Height	Measured in cm	Baseline