Exercise and Nutrition Intervention for Frail Older Patients

January 30, 2024 updated by: Laurine Nilsson, Aalborg University Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg Municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (A)
Intervention focusing on strength training and nutritional optimization.
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
Active Comparator: Control (B)
Usual care. Physiotherapy (type of training decided by the physiotherapist) without nutritional intervention.
Other: Standard training
Training as usual when discharged with a rehabilitation plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB)
Time Frame: 26 weeks
A group of measures that combines the results of the gait speed, chair stand and balance tests
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go
Time Frame: 26 weeks
A simple test used to assess a person's mobility and requires both static and dynamic balance.
26 weeks
Timed Up and Go
Time Frame: 15 weeks
A simple test used to assess a person's mobility and requires both static and dynamic balance.
15 weeks
Grip strength
Time Frame: 26 weeks
Measures the muscular strength or the maximum force generated using a hand held dynamometer
26 weeks
Grip strength
Time Frame: 15 weeks
Measures the muscular strength or the maximum force generated using a hand held dynamometer
15 weeks
Tilburg Frailty Indicator
Time Frame: 26 weeks
The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people
26 weeks
Tilburg Frailty Indicator
Time Frame: 15 weeks
The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people
15 weeks
Clinical Frailty Scale (CFS)
Time Frame: 26 weeks
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
Clinical Frailty Scale (CFS)
Time Frame: 15 weeks
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
Body mass, body fat mass and body muscle mass
Time Frame: 26 weeks
Inbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.
26 weeks
Body mass, body fat mass and body muscle mass
Time Frame: 15 weeks
Inbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.
15 weeks
Admission
Time Frame: 26 weeks.
Number of admissions
26 weeks.
Admission
Time Frame: 15 weeks.
Number of admissions
15 weeks.
Home care
Time Frame: 26 weeks.
Hours of home care
26 weeks.
Home care
Time Frame: 15 weeks.
Hours of home care
15 weeks.
Other healthcare services
Time Frame: 26 weeks.
ex. Occupational therapy or psychologist
26 weeks.
Short Physical Performance Battery (SPPB)
Time Frame: 15 weeks
A group of measures that combines the results of the gait speed, chair stand and balance tests
15 weeks
Height
Time Frame: Baseline
Measured in cm
Baseline
EQ5D-5L
Time Frame: 26 weeks
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
EQ5D-5L
Time Frame: 15 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Principal Investigator: Laurine Nilsson, PhD stud., Aalborg University Hospital
  • Study Chair: Jane Andreasen, Assoc. prof., Aalborg University Hospital and Aalborg Municipality
  • Study Chair: Mette Holst, Aalborg University Hospital and Aalborg University
  • Study Chair: Morten Villumsen, Aarhus Municipality

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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