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Completed

NCT Number: NCT05831982

Exercise and Nutrition Intervention for Frail Older Patients

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Municipality

Aalborg, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Standard Training

Other

Training as usual when discharged with a rehabilitation plan.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Grip strength

    Time frame: 26 weeks

    Measures the muscular strength or the maximum force generated using a hand held dynamometer

  4. Grip strength

    Time frame: 15 weeks

    Measures the muscular strength or the maximum force generated using a hand held dynamometer

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  12. 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.

  13. Admission

    Time frame: 26 weeks.

    Number of admissions

  14. Admission

    Time frame: 15 weeks.

    Number of admissions

  15. Home care

    Time frame: 26 weeks.

    Hours of home care

  16. Home care

    Time frame: 15 weeks.

    Hours of home care

  17. Other healthcare services

    Time frame: 26 weeks.

    ex. Occupational therapy or psychologist

  18. 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

  19. Height

    Time frame: Baseline

    Measured in cm

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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