Exercise and Nutrition Intervention for Frail Older Patients

Study Overview
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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.

Official Title
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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.

Conditions
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Frailty

Intervention / Treatment
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* Other: Person-centered strength training and nutrition intervention
* Other: Standard training


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (A)<br>Intervention focusing on strength training and nutritional optimization. | Other: Person-centered strength training and nutrition intervention<br>* Focus on high intensity strength training and nutrition intervention with focus on energy and protein intake. Focus on social relations<br>|
| Active Comparator: Control (B)<br>Usual care. Physiotherapy (type of training decided by the physiotherapist) without nutritional intervention. | Other: Standard training<br>* Training as usual when discharged with a rehabilitation plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go | A simple test used to assess a person's mobility and requires both static and dynamic balance. | 26 weeks | 
| Timed Up and Go | A simple test used to assess a person's mobility and requires both static and dynamic balance. | 15 weeks | 
| Grip strength | Measures the muscular strength or the maximum force generated using a hand held dynamometer | 26 weeks | 
| Grip strength | Measures the muscular strength or the maximum force generated using a hand held dynamometer | 15 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Admission | Number of admissions | 26 weeks. | 
| Admission | Number of admissions | 15 weeks. | 
| Home care | Hours of home care | 26 weeks. | 
| Home care | Hours of home care | 15 weeks. | 
| Other healthcare services | ex. Occupational therapy or psychologist | 26 weeks. | 
| Short Physical Performance Battery (SPPB) | A group of measures that combines the results of the gait speed, chair stand and balance tests | 15 weeks | 
| Height | Measured in cm | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older, frailty, strength training, nutrition