FrailtyNCT05831982
Exercise and Nutrition Intervention for Frail Older Patients
A study testing Person-centered strength training and nutrition intervention and Standard training in people with Frailty, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Person-centered strength training and nutrition intervention and Standard training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Discharged with rehabilitatinplan for physiotherapy within the last 30 days.
- Dementia or other cognitive impairments.
- Terminal ill.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Person-centered strength training and nutrition intervention, Standard training
- Keywords
- older, frailty, strength training, nutrition
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centered strength training and nutrition interventionOther
Focus on high intensity strength training and nutrition intervention with focus on energy and protein intake. Focus on social relations
Standard trainingOther
Training as usual when discharged with a rehabilitation plan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (A) | Experimental | Intervention focusing on strength training and nutritional optimization. Receives: 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. Receives: Other: Standard training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
A group of measures that combines the results of the gait speed, chair stand and balance tests
Measured: 26 weeks
Secondary outcomes (19)
Timed Up and Go
A simple test used to assess a person's mobility and requires both static and dynamic balance.
Measured: 26 weeks
Timed Up and Go
A simple test used to assess a person's mobility and requires both static and dynamic balance.
Measured: 15 weeks
Grip strength
Measures the muscular strength or the maximum force generated using a hand held dynamometer
Measured: 26 weeks
Grip strength
Measures the muscular strength or the maximum force generated using a hand held dynamometer
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 15 weeks
Admission
Number of admissions
Measured: 26 weeks.
Admission
Number of admissions
Measured: 15 weeks.
Home care
Hours of home care
Measured: 26 weeks.
Home care
Hours of home care
Measured: 15 weeks.
Other healthcare services
ex. Occupational therapy or psychologist
Measured: 26 weeks.
Short Physical Performance Battery (SPPB)
A group of measures that combines the results of the gait speed, chair stand and balance tests
Measured: 15 weeks
Height
Measured in cm
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Nov 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurine Nilsson, Aalborg University Hospital
- Investigators
- Laurine Nilsson, PhD stud., Principal investigator, Aalborg University HospitalJane Andreasen, Assoc. prof., Study chair, Aalborg University Hospital and Aalborg MunicipalityMette Holst, Study chair, Aalborg University Hospital and Aalborg UniversityMorten Villumsen, Study chair, Aarhus Municipality, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831982
- Sponsor's protocol ID
- 2021-215
- Status last verified
- Jan 2024
- First submitted
- 29 Mar 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared
Publications
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.
PubMed 18824488Rossi 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.
PubMed 33360014Dedeyne 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.
PubMed 28579766Andreasen 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.
PubMed 29462759Nilsson 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.
PubMed 36189947Rasmussen 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.
PubMed 32483900Baert 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.
PubMed 21570493
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05831982
- Acronym / sponsor ID
- 2021-215
- Conditions
- Frailty
- Keywords
- older, frailty, strength training, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention (A) | Experimental | Other: Person-centered strength training and nutrition interventionIntervention focusing on strength training and nutritional optimization. |
| Control (B) | Active comparator | Other: Standard trainingUsual care. Physiotherapy (type of training decided by the physiotherapist) without nutritional intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Discharged with rehabilitatinplan for physiotherapy within the last 30 days.
- Dementia or other cognitive impairments.
- Terminal ill.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centered strength training and nutrition interventionFocus on high intensity strength training and nutrition intervention with focus on energy and protein intake. Focus on social relations | Other | Intervention (A) |
| Standard trainingTraining as usual when discharged with a rehabilitation plan. | Other | Control (B) |
Primary outcome
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
19 secondary outcomes
Timed Up and Go
Time frame: 26 weeks
Timed Up and Go
Time frame: 15 weeks
Grip strength
Time frame: 26 weeks
Grip strength
Time frame: 15 weeks
Tilburg Frailty Indicator
Time frame: 26 weeks
Tilburg Frailty Indicator
Time frame: 15 weeks
Clinical Frailty Scale (CFS)
Time frame: 26 weeks
Clinical Frailty Scale (CFS)
Time frame: 15 weeks
EQ5D-5L
Time frame: 26 weeks
EQ5D-5L
Time frame: 15 weeks
Body mass, body fat mass and body muscle mass
Time frame: 26 weeks
Body mass, body fat mass and body muscle mass
Time frame: 15 weeks
Admission
Time frame: 26 weeks.
Admission
Time frame: 15 weeks.
Home care
Time frame: 26 weeks.
Home care
Time frame: 15 weeks.
Other healthcare services
Time frame: 26 weeks.
Short Physical Performance Battery (SPPB)
Time frame: 15 weeks
Height
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 18824488Craig 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.
- Background: PubMed 33360014Rossi 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.
- Background: PubMed 28579766Dedeyne 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.
- Background: PubMed 29462759Andreasen 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.
- Background: PubMed 36189947Nilsson 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.
- Background: PubMed 32483900Rasmussen 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.
- Background: PubMed 21570493Baert 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.
- Individual participant dataSharing planned: No. No data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurine Nilsson, PhD stud. principal investigator
Aalborg University Hospital
Jane Andreasen, Assoc. prof. study chair
Aalborg University Hospital and Aalborg Municipality
Mette Holst study chair
Aalborg University Hospital and Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centered strength training and nutrition intervention and Standard training in people with Frailty, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831982, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.