Exercise and Nutrition Intervention for Frail Older Patients

NCT ID: NCT05831982

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Frailty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Due to the vulnerable group masking was not possible for care provider or baseline tester, but randomization will take place after baseline tests have been performed. Tester at 15 and 26 weeks will be masked.

Study Groups

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Intervention (A)

Intervention focusing on strength training and nutritional optimization.

Group Type EXPERIMENTAL

Person-centered strength training and nutrition intervention

Intervention Type OTHER

Focus on high intensity strength training and nutrition intervention with focus on energy and protein intake. Focus on social relations

Control (B)

Usual care. Physiotherapy (type of training decided by the physiotherapist) without nutritional intervention.

Group Type ACTIVE_COMPARATOR

Standard training

Intervention Type OTHER

Training as usual when discharged with a rehabilitation plan.

Interventions

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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

Intervention Type OTHER

Standard training

Training as usual when discharged with a rehabilitation plan.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Laurine Nilsson

Physiotherapist, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurine Nilsson, PhD stud.

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Jane Andreasen, Assoc. prof.

Role: STUDY_CHAIR

Aalborg University Hospital and Aalborg Municipality

Mette Holst

Role: STUDY_CHAIR

Aalborg University Hospital and Aalborg University

Morten Villumsen

Role: STUDY_CHAIR

Aarhus Municipality, Denmark

Locations

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Aalborg Municipality

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 18824488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33360014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28579766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29462759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36189947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32483900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21570493 (View on PubMed)

Other Identifiers

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2021-215

Identifier Type: -

Identifier Source: org_study_id

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