Exercise and Nutrition Intervention for Frail Older Patients

Sponsor
Aalborg University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05831982
Collaborator
(none)
120
1
2
31.9
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 1. Goalsetting conversation before start of training. 2. Strength training two times a week for 15 weeks. 3. Three conversations with dietician. 4. Focus on social relations.
  • Other: Standard training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
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.
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention (A)

Intervention focusing on strength training and nutritional optimization.

Other: 1. Goalsetting conversation before start of training. 2. Strength training two times a week for 15 weeks. 3. Three conversations with dietician. 4. Focus on social relations.
Focus on high intensity strength training and nutrition intervention with focus on energy and protein intake.

Active Comparator: Control (B)

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

Other: Standard training
Training as usual when discharged with a rehabilitation plan.

Outcome Measures

Primary Outcome Measures

  1. Short Physical Performance Battery (SPPB) [26 weeks]

    A group of measures that combines the results of the gait speed, chair stand and balance tests

Secondary Outcome Measures

  1. Timed Up and Go [26 weeks]

    A simple test used to assess a person's mobility and requires both static and dynamic balance.

  2. Timed Up and Go [15 weeks]

    A simple test used to assess a person's mobility and requires both static and dynamic balance.

  3. Grip strength [26 weeks]

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

  4. Grip strength [15 weeks]

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

  5. Tilburg Frailty Indicator [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 [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) [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) [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 [26 weeks]

    A descriptive system which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  10. EQ5D-5L [15 weeks]

    A descriptive system which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  11. Body mass, body fat mass and body muscle mass [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 [15 weeks]

    Inbody270 measurement. I scale measuring mass, fat mass and muscle mass at the same time. Measured in kg.

  13. Admission [26 weeks.]

    Number of admissions

  14. Admission [15 weeks.]

    Number of admissions

  15. Home care [26 weeks.]

    Hours of home care

  16. Home care [15 weeks.]

    Hours of home care

  17. Other healthcare services [26 weeks.]

    ex. Occupational therapy or psychologist

  18. Short Physical Performance Battery (SPPB) [15 weeks]

    A group of measures that combines the results of the gait speed, chair stand and balance tests

  19. Height [Baseline]

    Measured in cm

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aalborg Municipality Aalborg Denmark

Sponsors and Collaborators

  • Aalborg University Hospital

Investigators

  • Principal Investigator: Laurine Nilsson, PhD stud., Aalborg University Hospital
  • Study Chair: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Laurine Nilsson, Physiotherapist, PhD student, Aalborg University Hospital
ClinicalTrials.gov Identifier:
NCT05831982
Other Study ID Numbers:
  • 2021-215
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Laurine Nilsson, Physiotherapist, PhD student, Aalborg University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023