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Exercise and Nutrition Intervention for Frail Older Patients

Primary Purpose

Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Person-centered strength training and nutrition intervention
Standard training
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty focused on measuring older, frailty, strength training, nutrition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aalborg MunicipalityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention (A)

Control (B)

Arm Description

Intervention focusing on strength training and nutritional optimization.

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

Outcomes

Primary Outcome Measures

Short Physical Performance Battery (SPPB)
A group of measures that combines the results of the gait speed, chair stand and balance tests

Secondary Outcome Measures

Timed Up and Go
A simple test used to assess a person's mobility and requires both static and dynamic balance.
Timed Up and Go
A simple test used to assess a person's mobility and requires both static and dynamic balance.
Grip strength
Measures the muscular strength or the maximum force generated using a hand held dynamometer
Grip strength
Measures the muscular strength or the maximum force generated using a hand held dynamometer
Tilburg Frailty Indicator
The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people
Tilburg Frailty Indicator
The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people
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)
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)
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)
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)
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.
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.
Admission
Number of admissions
Admission
Number of admissions
Home care
Hours of home care
Home care
Hours of home care
Other healthcare services
ex. Occupational therapy or psychologist
Short Physical Performance Battery (SPPB)
A group of measures that combines the results of the gait speed, chair stand and balance tests
Height
Measured in cm

Full Information

First Posted
March 29, 2023
Last Updated
August 1, 2023
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05831982
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
older, frailty, strength training, nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (A)
Arm Type
Experimental
Arm Description
Intervention focusing on strength training and nutritional optimization.
Arm Title
Control (B)
Arm Type
Active Comparator
Arm Description
Usual care. Physiotherapy (type of training decided by the physiotherapist) without nutritional intervention.
Intervention Type
Other
Intervention Name(s)
Person-centered strength training and nutrition intervention
Intervention Description
Focus on high intensity strength training and nutrition intervention with focus on energy and protein intake. Focus on social relations
Intervention Type
Other
Intervention Name(s)
Standard training
Intervention Description
Training as usual when discharged with a rehabilitation plan.
Primary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
A group of measures that combines the results of the gait speed, chair stand and balance tests
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go
Description
A simple test used to assess a person's mobility and requires both static and dynamic balance.
Time Frame
26 weeks
Title
Timed Up and Go
Description
A simple test used to assess a person's mobility and requires both static and dynamic balance.
Time Frame
15 weeks
Title
Grip strength
Description
Measures the muscular strength or the maximum force generated using a hand held dynamometer
Time Frame
26 weeks
Title
Grip strength
Description
Measures the muscular strength or the maximum force generated using a hand held dynamometer
Time Frame
15 weeks
Title
Tilburg Frailty Indicator
Description
The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people
Time Frame
26 weeks
Title
Tilburg Frailty Indicator
Description
The Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people
Time Frame
15 weeks
Title
Clinical Frailty Scale (CFS)
Description
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)
Time Frame
26 weeks
Title
Clinical Frailty Scale (CFS)
Description
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)
Time Frame
15 weeks
Title
EQ5D-5L
Description
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)
Time Frame
26 weeks
Title
EQ5D-5L
Description
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)
Time Frame
15 weeks
Title
Body mass, body fat mass and body muscle mass
Description
Inbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.
Time Frame
26 weeks
Title
Body mass, body fat mass and body muscle mass
Description
Inbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.
Time Frame
15 weeks
Title
Admission
Description
Number of admissions
Time Frame
26 weeks.
Title
Admission
Description
Number of admissions
Time Frame
15 weeks.
Title
Home care
Description
Hours of home care
Time Frame
26 weeks.
Title
Home care
Description
Hours of home care
Time Frame
15 weeks.
Title
Other healthcare services
Description
ex. Occupational therapy or psychologist
Time Frame
26 weeks.
Title
Short Physical Performance Battery (SPPB)
Description
A group of measures that combines the results of the gait speed, chair stand and balance tests
Time Frame
15 weeks
Title
Height
Description
Measured in cm
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurine Nilsson, PhD stud.
Phone
+45 24216645
Email
laurine.nilsson@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Andreasen, Assoc. prof.
Email
jaan@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurine Nilsson, PhD stud.
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Andreasen, Assoc. prof.
Organizational Affiliation
Aalborg University Hospital and Aalborg Municipality
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mette Holst
Organizational Affiliation
Aalborg University Hospital and Aalborg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Morten Villumsen
Organizational Affiliation
Aarhus Municipality
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg Municipality
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurine Nilsson

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared
Citations:
PubMed Identifier
18824488
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.
Results Reference
background
PubMed Identifier
33360014
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.
Results Reference
background
PubMed Identifier
28579766
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.
Results Reference
background
PubMed Identifier
29462759
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.
Results Reference
background
PubMed Identifier
36189947
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. 2022 Oct 3:1-10. doi: 10.1080/09593985.2022.2122912. Online ahead of print.
Results Reference
background
PubMed Identifier
32483900
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.
Results Reference
background
PubMed Identifier
21570493
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.
Results Reference
background

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Exercise and Nutrition Intervention for Frail Older Patients

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