Exercise and Nutrition Intervention for Frail Older Patients

NCT05831982 | Completed

• 1 other identifier: 2021-215
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

older; frailty; strength training; nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Timed Up and Go

  26 weeks

• Timed Up and Go

  15 weeks

• Grip strength

  26 weeks

• Grip strength

  15 weeks

• Tilburg Frailty Indicator

  26 weeks

Study Arms (2)

Intervention (A)

EXPERIMENTAL

Intervention focusing on strength training and nutritional optimization.

Other: Person-centered strength training and nutrition intervention

Control (B)

ACTIVE COMPARATOR

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

Other: Standard training

Interventions

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

Intervention (A)

Standard training OTHER

Training as usual when discharged with a rehabilitation plan.

Control (B)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• Discharged with rehabilitatinplan for physiotherapy within the last 30 days.
• Dementia or other cognitive impairments.
• Terminal ill.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg Municipality

Aalborg, Denmark

Location

Related Publications (7)

• 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.

  PMID: 18824488 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.

  PMID: 33360014 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.

  PMID: 28579766 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.

  PMID: 29462759 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.

  PMID: 36189947 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.

  PMID: 32483900 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.

  PMID: 21570493 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD student

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 27, 2023
• Study Start: November 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)