Hospitalized Older Medical PatientsNCT01964482
In-hospital and Post-discharge Training of Older Medical Patients
A study testing Strength training in people with Hospitalized Older Medical Patients, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
The project aims to investigate the clinical value of simple strength training during hospitalization and after discharge as part of an enhanced recovery programme for acutely admitted older medical patients, in order to prevent mobility decline following acute hospitalization. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hospitalized Older Medical Patients
- What is being tested?
- Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Oct 2018
- 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 of age
- admitted from own home
Who cannot join
- Terminal illness
- In treatment for diagnosed cancer
- Assigned to physical rehabilitation in community
- Chronic Obstructive Pulmonary Disease (COPD) patients participating in organized rehabilitation
- Living outside of the municipalities of Copenhagen and Broendby
- Not able to talk and understand danish
Show all 9Show fewer
- Not able to cooperate on tests/exercises
- Hospitalized < 24 hours
- A Cumulated Ambulation Score (CAS) of 0 in the sit-to-stand item
Trial locations and contacts
1 site in 1 country.
About this study
The project aims to investigate the clinical value of simple strength training during hospitalization and after discharge as part of an enhanced recovery programme for acutely admitted older medical patients, in order to prevent mobility decline following acute hospitalization.
Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve sufficient power to look more deeply into our secondary outcomes. This will constitute a secondary part of the trial (started Nov. 2016). The primary trial report will include data for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence, the primary completion date for part 1 was April 2016 and the study completion date for part 1 was Oct 2016. The trial status is still "recruiting" although this applies to part 2 of the study.
- Conditions
- Hospitalized Older Medical Patients
- Being tested
- Strength training
- Keywords
- Hospitalization, Older, Medical patient, Strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
Strength training followed by intake of a protein drink
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Supervised strength training daily during hospitalization and 3 times per week for 4 weeks after discharge in the participant's home Receives: Other: Strength training |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility using the de Morton Mobility Index (DEMMI)
The DEMMI is an advanced instrument for accurately measuring the mobility of older people across clinical settings (www.demmi.org.au). The primary analysis for the primary outcome is the change in the DEMMI score from baseline to the assessment 4 weeks after discharge (end of intervention). The primary analysis will follow the intention-to-treat principle (last observation carried forward) and be unadjusted in order to determine a systematic group-difference in the change from baseline to 4 weeks post discharge (end of training) for the primary outcome.
Measured: Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge
Secondary outcomes (5)
Isometric knee-extension strength in dominant leg
Isometric knee-extension strength will be measured using an externally fixated handheld dynamometer (Power Track II Commander; JTech Medical, Utah). A stap will be attached to the bed/chair and the patient's ankle (perpendicular to the lower leg), ensuring 90 degrees of knee flexion and an isometric contraction. The transducer will be placed under the strap at ankle level, just proximal to the malleolus, and the participant will be asked to extend the leg as forcefully as possible. Knee-extension strength will be expressed as the maximal voluntary torque per kilo body mass ([NIm]/kg), using the distance between the lateral femoral epicondyle and the center of the transducer and the body mass of each patient.
Measured: At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge
Hand-grip strength of dominant hand
Isometric handgrip strength will be measured in the dominant hand using a handheld dynamometer (Digi-II; Saehan). The patient will be placed in a sitting position in an armchair, with the lower arm placed on the arm rest and an elbow flexion of 90 degrees. The patients will be asked to squeeze the handle as forcefully as possible for 5 secs. Handgrip strength will be expressed in kilograms.
Measured: Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge
30-sec sit to stand test
The patients will be asked to stand up and sit down as many times as possible in 30 secs with their arms across their chest.
Measured: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge
Habitual gait speed
Patients will be asked to walk a 4-meter straight walk at their usual pace starting from a standing position.
Measured: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge
24-hour mobility
The patients will be asked to wear an ActivPAL3 activity monitor (PAL Technologies Ltd, Scotland) on the thigh during hospitalization, the first week after discharge, the first weeks after the 4-week assessment and the first week after the 26-week assessment.
Measured: Admittance to discharge, discharge to 1 week post discharge, 4 weeks post discharge to 5 weeks post discharge, 26 weeks post discharge to 27 weeks post discharge (4 x 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hospitalized Older Medical PatientsStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Merete Pedersen, Copenhagen University Hospital, Hvidovre
- Investigators
- Mette M Pedersen, PhD Student, Principal investigator, Hvidovre Hospital, University of CopenhagenThomas Q Bandholm, PhD, Study director, Hvidovre Hospital, University of CopenhagenJanne Petersen, PhD, Study director, Hvidovre Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964482
- Sponsor's protocol ID
- H-2-2012-115
- Status last verified
- Dec 2018
- First submitted
- 14 Oct 2013
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bornaes O, Andersen AL, Houlind MB, Kallemose T, Tavenier J, Aharaz A, Nielsen RL, Jorgensen LM, Beck AM, Andersen O, Petersen J, Pedersen MM. Mild Cognitive Impairment Is Associated with Poorer Nutritional Status on Hospital Admission and after Discharge in Acutely Hospitalized Older Patients. Geriatrics (Basel). 2022 Sep 10;7(5):95. doi: 10.3390/geriatrics7050095.
PubMed 36136804Pedersen MM, Petersen J, Beyer N, Larsen HG, Jensen PS, Andersen O, Bandholm T; STAND-Cph collaborative group. A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial. Trials. 2019 Nov 28;20(1):655. doi: 10.1186/s13063-019-3720-x.
PubMed 31779693Pedersen MM, Petersen J, Beyer N, Damkjaer L, Bandholm T. Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial). Trials. 2016 Apr 1;17:176. doi: 10.1186/s13063-016-1309-1.
PubMed 27039381
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital and Post-discharge Training of Older Medical Patients
- ClinicalTrials.gov ID
- NCT01964482
- Acronym / sponsor ID
- H-2-2012-115
- Conditions
- Hospitalized Older Medical Patients
- Keywords
- Hospitalization, Older, Medical patient, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 17 Oct 2013 (estimated)
- 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 project aims to investigate the clinical value of simple strength training during hospitalization and after discharge as part of an enhanced recovery programme for acutely admitted older medical patients, in order to prevent mobility decline following acute hospitalization.
Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve sufficient power to look more deeply into our secondary outcomes. This will constitute a secondary part of the trial (started Nov. 2016). The primary trial report will include data for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence, the primary completion date for part 1 was April 2016 and the study completion date for part 1 was Oct 2016. The trial status is still "recruiting" although this applies to part 2 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Other: Strength trainingSupervised strength training daily during hospitalization and 3 times per week for 4 weeks after discharge in the participant's home |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- >=65 years of age
- admitted from own home
Key exclusion criteria (9 listed)
- Terminal illness
- In treatment for diagnosed cancer
- Assigned to physical rehabilitation in community
- Chronic Obstructive Pulmonary Disease (COPD) patients participating in organized rehabilitation
- Living outside of the municipalities of Copenhagen and Broendby
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 |
|---|---|---|
| Strength trainingStrength training followed by intake of a protein drink | Other | Strength training |
Primary outcome
Mobility using the de Morton Mobility Index (DEMMI)
Time frame: Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge
The DEMMI is an advanced instrument for accurately measuring the mobility of older people across clinical settings (www.demmi.org.au). The primary analysis for the primary outcome is the change in the DEMMI score from baseline to the assessment 4 weeks after discharge (end of intervention). The primary analysis will follow the intention-to-treat principle (last observation carried forward) and be unadjusted in order to determine a systematic group-difference in the change from baseline to 4 weeks post discharge (end of training) for the primary outcome.
5 secondary outcomes
Isometric knee-extension strength in dominant leg
Time frame: At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge
Hand-grip strength of dominant hand
Time frame: Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge
30-sec sit to stand test
Time frame: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge
Habitual gait speed
Time frame: Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge
24-hour mobility
Time frame: Admittance to discharge, discharge to 1 week post discharge, 4 weeks post discharge to 5 weeks post discharge, 26 weeks post discharge to 27 weeks post discharge (4 x 1 week)
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 5 Dec 2018.
- Derived from this study: PubMed 36136804Bornaes O, Andersen AL, Houlind MB, Kallemose T, Tavenier J, Aharaz A, Nielsen RL, Jorgensen LM, Beck AM, Andersen O, Petersen J, Pedersen MM. Mild Cognitive Impairment Is Associated with Poorer Nutritional Status on Hospital Admission and after Discharge in Acutely Hospitalized Older Patients. Geriatrics (Basel). 2022 Sep 10;7(5):95. doi: 10.3390/geriatrics7050095.
- Derived from this study: PubMed 31779693Pedersen MM, Petersen J, Beyer N, Larsen HG, Jensen PS, Andersen O, Bandholm T; STAND-Cph collaborative group. A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial. Trials. 2019 Nov 28;20(1):655. doi: 10.1186/s13063-019-3720-x.
- Derived from this study: PubMed 27039381Pedersen MM, Petersen J, Beyer N, Damkjaer L, Bandholm T. Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial). Trials. 2016 Apr 1;17:176. doi: 10.1186/s13063-016-1309-1.
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.
Mette M Pedersen, PhD Student principal investigator
Hvidovre Hospital, University of Copenhagen
Thomas Q Bandholm, PhD study director
Hvidovre Hospital, University of Copenhagen
Janne Petersen, PhD study director
Hvidovre Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in people with Hospitalized Older Medical Patients, run by Copenhagen University Hospital, Hvidovre 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 2 inclusion and 9 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 5 Dec 2018. 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?
Mobility using the de Morton Mobility Index (DEMMI) (time frame: Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge). 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 NCT01964482, which also lists 3 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 5 Dec 2018.