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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (A) | Experimental | Intervention focusing on strength training and nutritional optimization. |
|
| Control (B) | Active Comparator | Usual care. Physiotherapy (type of training decided by the physiotherapist) without nutritional intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Person-centered strength training and nutrition intervention | Other | Focus on high intensity strength training and nutrition intervention with focus on energy and protein intake. Focus on social relations |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurine Nilsson, PhD stud. | Aalborg University Hospital | Principal Investigator |
| 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, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Municipality | Aalborg | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18824488 | Background | 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. | |
| 33360014 | Background | 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. |
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No data will be shared
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Randomized controlled trial
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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.
| Standard training | Other | Training as usual when discharged with a rehabilitation plan. |
|
| 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 |
| 28579766 | Background | 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. |
| 29462759 | Background | 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. |
| 36189947 | Background | 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. |
| 32483900 | Background | 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. |
| 21570493 | Background | 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. |