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Exercise and Nutrition Intervention for Frail Older Patients

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05831982
Enrollment
119
Registered
2023-04-27
Start date
2021-11-01
Completion date
2023-09-30
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Keywords

older, frailty, strength training, nutrition

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.

Interventions

OTHERPerson-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

Training as usual when discharged with a rehabilitation plan.

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Short Physical Performance Battery (SPPB)26 weeksA group of measures that combines the results of the gait speed, chair stand and balance tests

Secondary

MeasureTime frameDescription
HeightBaselineMeasured in cm
Timed Up and Go26 weeksA simple test used to assess a person's mobility and requires both static and dynamic balance.
Grip strength26 weeksMeasures the muscular strength or the maximum force generated using a hand held dynamometer
Tilburg Frailty Indicator26 weeksThe Tilburg Frailty Indicator (TFI) is a self-report user-friendly questionnaire for assessing multidimensional frailty among community-dwelling older people
Clinical Frailty Scale (CFS)26 weeksThe 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)
Short Physical Performance Battery (SPPB)15 weeksA group of measures that combines the results of the gait speed, chair stand and balance tests
Body mass, body fat mass and body muscle mass26 weeksInbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.
Admission26 weeks.Number of admissions
Home care26 weeks.Hours of home care
Other healthcare services26 weeks.ex. Occupational therapy or psychologist
EQ5D-5L26 weeksA 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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026