Mobility LimitationHOMENCT05484063
Help Optimise and Mobilise Elders (H.O.M.E)
A study testing Multicomponent, mobility-focused intervention in people with Mobility Limitation and Functional Disturbance, run by JurongHealth at 2 sites in Singapore.
Trial summary
During hospitalisations, older inpatients commonly face issues such as immobility, loss of independence, and functional decline. This leads them down the cascade of dependency with consequent increased risk of adverse outcomes, institutionalisation as well as higher post-acute care costs. Read more about this study
- Who is it for?
- Ages 21 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation, Functional Disturbance
- What is being tested?
- Multicomponent, mobility-focused intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSingapore
- Study dates
- 25 Jul 2022to 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 21 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly admitted patients to the geriatric service
- Aged 75 years and above
- Mobile with or without the use of a walking aid
Who cannot join
- Vancomycin-resistant enterococcus (VRE) status
- Requires droplet or airborne precautions
- Critically ill
- Haemodynamically instability
- Requires more than 4-hourly parameters
- Systolic blood pressure <90 mmHg
Show all 10Show fewer
- Heart rate >100beats/min
- Non-ambulant patients
- With advanced dementia (Functional Assessment Staging Scale [FAST] 7 dementia)
- Fulfills direct admission to another subspecialty unit
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Ng Teng Fong Hospital
Singapore, 609606
Melanie Tan Dr, 67165237, melanie_tan@nuhs.edu.sg
Seok Mei Lim Dr
Geriatrics Education and Research Institute
Singapore, 768024
Lau Lay Khoon Dr, 68078031, lau.charlene.lk@geri.com.sg
Tou Nien Xiang Dr
About this study
During hospitalisations, older inpatients commonly face issues such as immobility, loss of independence, and functional decline. This leads them down the cascade of dependency with consequent increased risk of adverse outcomes, institutionalisation as well as higher post-acute care costs. The investigators hypothesize that by implementing a mobility intervention in the inpatient setting, patients would be able to maintain their function upon discharge and avoid the cascade of dependency. As such, the investigators aim to do this by implementing and evaluating a mobility intervention, while optimising reversible factors affecting mobility among inpatients admitted to a geriatric unit in Singapore. The investigators will also examine the cost impact of a mobility focused model of care and also adopt the effectiveness-implementation hybrid Type 2 design where both effectiveness and implementation spheres are tested simultaneously.
Read the detailed description
Aim 1: To examine the effectiveness of multicomponent, mobility-focused model of care in reducing iatrogenic complications and improving patient outcomes. Adopting the Institute for Healthcare Improvement's (IHI) 4Ms framework ("Mobility", "Mentation, "Medication", and "What Matters"), the investigators will examine the effectiveness of timely and individually catered mobility interventions which not only increase mobilization but also optimize factors inhibiting mobility for elderly inpatients. It is hypothesized that the mobility outcomes, such as maximum distance walked and mobilization frequency will be significantly improved for patients who receive the intervention compared to those who receive standard care.
Aim 2: To examine the cost impact of a mobility-focused model of care. The investigators will examine whether the cost of these multicomponent, mobility-focused interventions can be offset from cost savings from early mobilisation benefits, by comparing healthcare utilization costs between-groups. Further to that, a cost effectiveness analysis will be performed should functional effectiveness be observed. For the primary cost impact objective, it is hypothesized that the cost savings arising from reduction in bed days of hospitalization and other medical costs incurred during study period will outweigh the cost of implementing this model of care. In addition, it is also hypothesized that the proposed intervention will be cost-effective through achieving better functional outcomes for patients, with lower costs required.
Aim 3: To evaluate the implementation outcomes of multicomponent, mobility-focused model of care in the process of this intervention. It is hypothesized that this intervention will have good acceptability, feasibility, penetration, implementation costs and sustainability.
- Conditions
- Mobility Limitation, Functional Disturbance
- Being tested
- Multicomponent, mobility-focused intervention
- Keywords
- Elderly, Geriatric, Mobility, Inpatient, Functional Decline, Mobility Intervention, Gait speed, Maximum distance walked, Cost impact, length of stay, Multidisciplinary, Implementation study, 4Ms (Mobility, Mentation, Medication, What Matters), Nursing screen, Group therapy
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent, mobility-focused interventionOther
The intervention group will receive early therapist review (within one working day of admission to HOME unit), to be mobilised at least three times a day. They will also receive additional group exercise therapy sessions, as well as nurse screening for geriatric syndromes. Besides that, they will be screened for 4Ms (Mobility, Mentation, Medication, What Matters) by doctor on admission.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission. Receives: Other: Multicomponent, mobility-focused intervention |
| Control | No intervention | The control group will receive usual care as per current ward practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum distance walked
The total distance covered by the research participant (in meter)
Measured: Upon admission and at the point of discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Mobilisation frequency
Number of times mobilised. The average mobilisation frequency will be calculated by dividing the sum by the number of admission days.
Measured: Through the duration of admission
Secondary outcomes (6)
Change in modified barthel score
The score ranges from 0 to 100 with 0 as the worst outcome
Measured: Upon admission, at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay), and one-month post discharge
Change in gait speed
4 meter gait speed test (meter/second)
Measured: Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Inpatient length of stay and discharge location
The duration of admission (days) and the location the respective participant is discharged to
Measured: The duration of admission and upon discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
Each of the complication will be measured in nominal scale; 0 denotes the absence of the complication while 1 denotes the presence of the complications. The total number of complications arise will be calculated. The greater the number indicates poorer outcome
Measured: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Gross amount of patient's bill during index admission, considering subsidy level
The total gross amount of participant's bill during index admission. The subsidy level will be documented
Measured: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
The intervention related costs for group therapy
The number of group therapy sessions attended by the participant multiply by the cost for one group therapy session. The subsidy level will be documented.
Measured: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start25 Jul 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It is a quasi-experimental design study.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JurongHealth
- Sponsor type
- Other government
- Collaborators
- Geriatric Education and Research Institute, National Healthcare Group, Singapore
- Responsible party
- Sponsor
- Investigators
- Melanie Tan Dr, Principal investigator, Ng Teng Fong General HospitalLau Lay Khoon Dr, Principal investigator, Geriatric Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484063
- Sponsor's protocol ID
- GERI1627
- Acronym
- HOME
- Status last verified
- Jun 2022
- First submitted
- 25 Jun 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Working together with Geriatric Education and Research Institute and National Healthcare Group (Health Services \& Outcomes Research).
Publications
Olson EV, Johnson BJ, Thompson LF. The hazards of immobility. 1967. Am J Nurs. 1990 Mar;90(3):43-8. No abstract available.
PubMed 2178421Hirsch CH, Sommers L, Olsen A, Mullen L, Winograd CH. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990 Dec;38(12):1296-303. doi: 10.1111/j.1532-5415.1990.tb03451.x.
PubMed 2123911Mate KS, Berman A, Laderman M, Kabcenell A, Fulmer T. Creating Age-Friendly Health Systems - A vision for better care of older adults. Healthc (Amst). 2018 Mar;6(1):4-6. doi: 10.1016/j.hjdsi.2017.05.005. Epub 2017 Aug 1.
PubMed 28774720Surkan MJ, Gibson W. Interventions to Mobilize Elderly Patients and Reduce Length of Hospital Stay. Can J Cardiol. 2018 Jul;34(7):881-888. doi: 10.1016/j.cjca.2018.04.033. Epub 2018 May 9.
PubMed 29960617Smith TO, Sreekanta A, Walkeden S, Penhale B, Hanson S. Interventions for reducing hospital-associated deconditioning: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Sep-Oct;90:104176. doi: 10.1016/j.archger.2020.104176. Epub 2020 Jul 6.
PubMed 32652367Murray ME, Wells TJ, Callen BL. Hospital resource utilization and functional decline of geriatric patients. Nurs Econ. 2003 May-Jun;21(3):114-9. No abstract available.
PubMed 12847984Loyd C, Markland AD, Zhang Y, Fowler M, Harper S, Wright NC, Carter CS, Buford TW, Smith CH, Kennedy R, Brown CJ. Prevalence of Hospital-Associated Disability in Older Adults: A Meta-analysis. J Am Med Dir Assoc. 2020 Apr;21(4):455-461.e5. doi: 10.1016/j.jamda.2019.09.015. Epub 2019 Nov 14.
PubMed 31734122Wu HY, Sahadevan S, Ding YY. Factors associated with functional decline of hospitalised older persons following discharge from an acute geriatric unit. Ann Acad Med Singap. 2006 Jan;35(1):17-23.
PubMed 16470269Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc. 2008 Dec;56(12):2171-9. doi: 10.1111/j.1532-5415.2008.02023.x.
PubMed 19093915Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.
PubMed 11129764Liu B, Moore JE, Almaawiy U, Chan WH, Khan S, Ewusie J, Hamid JS, Straus SE; MOVE ON Collaboration. Outcomes of Mobilisation of Vulnerable Elders in Ontario (MOVE ON): a multisite interrupted time series evaluation of an implementation intervention to increase patient mobilisation. Age Ageing. 2018 Jan 1;47(1):112-119. doi: 10.1093/ageing/afx128.
PubMed 28985310Hastings SN, Sloane R, Morey MC, Pavon JM, Hoenig H. Assisted early mobility for hospitalized older veterans: preliminary data from the STRIDE program. J Am Geriatr Soc. 2014 Nov;62(11):2180-4. doi: 10.1111/jgs.13095. Epub 2014 Oct 30.
PubMed 25354909Hastings SN, Choate AL, Mahanna EP, Floegel TA, Allen KD, Van Houtven CH, Wang V. Early Mobility in the Hospital: Lessons Learned from the STRIDE Program. Geriatrics (Basel). 2018 Dec;3(4):61. doi: 10.3390/geriatrics3040061. Epub 2018 Sep 26.
PubMed 30775370Smart DA, Dermody G, Coronado ME, Wilson M. Mobility Programs for the Hospitalized Older Adult: A Scoping Review. Gerontol Geriatr Med. 2018 Nov 1;4:2333721418808146. doi: 10.1177/2333721418808146. eCollection 2018 Jan-Dec.
PubMed 30450367Hoyer EH, Friedman M, Lavezza A, Wagner-Kosmakos K, Lewis-Cherry R, Skolnik JL, Byers SP, Atanelov L, Colantuoni E, Brotman DJ, Needham DM. Promoting mobility and reducing length of stay in hospitalized general medicine patients: A quality-improvement project. J Hosp Med. 2016 May;11(5):341-7. doi: 10.1002/jhm.2546. Epub 2016 Feb 5.
PubMed 26849277
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Help Optimise and Mobilise Elders (H.O.M.E)
- ClinicalTrials.gov ID
- NCT05484063
- Acronym / sponsor ID
- HOME / GERI1627
- Conditions
- Mobility Limitation, Functional Disturbance
- Keywords
- Elderly, Geriatric, Mobility, Inpatient, Functional Decline, Mobility Intervention, Gait speed, Maximum distance walked
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- JurongHealthOther government
- Collaborators
- Geriatric Education and Research Institute, National Healthcare Group, Singapore
- Study start
- 25 Jul 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Aug 2022 (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.
During hospitalisations, older inpatients commonly face issues such as immobility, loss of independence, and functional decline. This leads them down the cascade of dependency with consequent increased risk of adverse outcomes, institutionalisation as well as higher post-acute care costs. The investigators hypothesize that by implementing a mobility intervention in the inpatient setting, patients would be able to maintain their function upon discharge and avoid the cascade of dependency. As such, the investigators aim to do this by implementing and evaluating a mobility intervention, while optimising reversible factors affecting mobility among inpatients admitted to a geriatric unit in Singapore. The investigators will also examine the cost impact of a mobility focused model of care and also adopt the effectiveness-implementation hybrid Type 2 design where both effectiveness and implementation spheres are tested simultaneously.
Detailed description
Aim 1: To examine the effectiveness of multicomponent, mobility-focused model of care in reducing iatrogenic complications and improving patient outcomes. Adopting the Institute for Healthcare Improvement's (IHI) 4Ms framework ("Mobility", "Mentation, "Medication", and "What Matters"), the investigators will examine the effectiveness of timely and individually catered mobility interventions which not only increase mobilization but also optimize factors inhibiting mobility for elderly inpatients. It is hypothesized that the mobility outcomes, such as maximum distance walked and mobilization frequency will be significantly improved for patients who receive the intervention compared to those who receive standard care.
Aim 2: To examine the cost impact of a mobility-focused model of care. The investigators will examine whether the cost of these multicomponent, mobility-focused interventions can be offset from cost savings from early mobilisation benefits, by comparing healthcare utilization costs between-groups. Further to that, a cost effectiveness analysis will be performed should functional effectiveness be observed. For the primary cost impact objective, it is hypothesized that the cost savings arising from reduction in bed days of hospitalization and other medical costs incurred during study period will outweigh the cost of implementing this model of care. In addition, it is also hypothesized that the proposed intervention will be cost-effective through achieving better functional outcomes for patients, with lower costs required.
Aim 3: To evaluate the implementation outcomes of multicomponent, mobility-focused model of care in the process of this intervention. It is hypothesized that this intervention will have good acceptability, feasibility, penetration, implementation costs and sustainability.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a quasi-experimental design study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Multicomponent, mobility-focused interventionIntervention group will receive a multicomponent, mobility-focused intervention during the course of inpatient admission. |
| Control | No intervention | –The control group will receive usual care as per current ward practice. |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly admitted patients to the geriatric service
- Aged 75 years and above
- Mobile with or without the use of a walking aid
Key exclusion criteria (10 listed)
- Vancomycin-resistant enterococcus (VRE) status
- Requires droplet or airborne precautions
- Critically ill
- Haemodynamically instability
- Requires more than 4-hourly parameters
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 |
|---|---|---|
| Multicomponent, mobility-focused interventionThe intervention group will receive early therapist review (within one working day of admission to HOME unit), to be mobilised at least three times a day. They will also receive additional group exercise therapy sessions, as well as nurse screening for geriatric syndromes. Besides that, they will be screened for 4Ms (Mobility, Mentation, Medication, What Matters) by doctor on admission. | Other | Intervention |
Primary outcome
Change in maximum distance walked
Time frame: Upon admission and at the point of discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
The total distance covered by the research participant (in meter)
Mobilisation frequency
Time frame: Through the duration of admission
Number of times mobilised. The average mobilisation frequency will be calculated by dividing the sum by the number of admission days.
6 secondary outcomes
Change in modified barthel score
Time frame: Upon admission, at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay), and one-month post discharge
Change in gait speed
Time frame: Upon admission and at discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Inpatient length of stay and discharge location
Time frame: The duration of admission and upon discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Presence of common iatrogenic complications such as delirium, injurious falls, pressure ulcers, and venous thromboembolisms
Time frame: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Gross amount of patient's bill during index admission, considering subsidy level
Time frame: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
The intervention related costs for group therapy
Time frame: At discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 2178421Olson EV, Johnson BJ, Thompson LF. The hazards of immobility. 1967. Am J Nurs. 1990 Mar;90(3):43-8. No abstract available.
- Background: PubMed 2123911Hirsch CH, Sommers L, Olsen A, Mullen L, Winograd CH. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990 Dec;38(12):1296-303. doi: 10.1111/j.1532-5415.1990.tb03451.x.
- Background: PubMed 28774720Mate KS, Berman A, Laderman M, Kabcenell A, Fulmer T. Creating Age-Friendly Health Systems - A vision for better care of older adults. Healthc (Amst). 2018 Mar;6(1):4-6. doi: 10.1016/j.hjdsi.2017.05.005. Epub 2017 Aug 1.
- Background: PubMed 29960617Surkan MJ, Gibson W. Interventions to Mobilize Elderly Patients and Reduce Length of Hospital Stay. Can J Cardiol. 2018 Jul;34(7):881-888. doi: 10.1016/j.cjca.2018.04.033. Epub 2018 May 9.
- Background: PubMed 32652367Smith TO, Sreekanta A, Walkeden S, Penhale B, Hanson S. Interventions for reducing hospital-associated deconditioning: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2020 Sep-Oct;90:104176. doi: 10.1016/j.archger.2020.104176. Epub 2020 Jul 6.
- Background: PubMed 12847984Murray ME, Wells TJ, Callen BL. Hospital resource utilization and functional decline of geriatric patients. Nurs Econ. 2003 May-Jun;21(3):114-9. No abstract available.
- Background: PubMed 31734122Loyd C, Markland AD, Zhang Y, Fowler M, Harper S, Wright NC, Carter CS, Buford TW, Smith CH, Kennedy R, Brown CJ. Prevalence of Hospital-Associated Disability in Older Adults: A Meta-analysis. J Am Med Dir Assoc. 2020 Apr;21(4):455-461.e5. doi: 10.1016/j.jamda.2019.09.015. Epub 2019 Nov 14.
- Background: PubMed 16470269Wu HY, Sahadevan S, Ding YY. Factors associated with functional decline of hospitalised older persons following discharge from an acute geriatric unit. Ann Acad Med Singap. 2006 Jan;35(1):17-23.
- Background: PubMed 19093915Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc. 2008 Dec;56(12):2171-9. doi: 10.1111/j.1532-5415.2008.02023.x.
- Background: PubMed 11129764Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.
- Background: PubMed 28985310Liu B, Moore JE, Almaawiy U, Chan WH, Khan S, Ewusie J, Hamid JS, Straus SE; MOVE ON Collaboration. Outcomes of Mobilisation of Vulnerable Elders in Ontario (MOVE ON): a multisite interrupted time series evaluation of an implementation intervention to increase patient mobilisation. Age Ageing. 2018 Jan 1;47(1):112-119. doi: 10.1093/ageing/afx128.
- Background: PubMed 25354909Hastings SN, Sloane R, Morey MC, Pavon JM, Hoenig H. Assisted early mobility for hospitalized older veterans: preliminary data from the STRIDE program. J Am Geriatr Soc. 2014 Nov;62(11):2180-4. doi: 10.1111/jgs.13095. Epub 2014 Oct 30.
- Individual participant dataSharing planned: Yes. Working together with Geriatric Education and Research Institute and National Healthcare Group (Health Services \& Outcomes Research).
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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.
Melanie Tan Dr principal investigator
Ng Teng Fong General Hospital
Lau Lay Khoon Dr principal investigator
Geriatric Education and Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent, mobility-focused intervention in people with Mobility Limitation and Functional Disturbance, run by JurongHealth at 2 sites in Singapore.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Tan Dr (67165237, melanie_tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum distance walked (time frame: Upon admission and at the point of discharge (an average of 10 days after inclusion. Analysis will take into account the variability of length of stay)). The study lists 2 primary outcomes in all. 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 NCT05484063, which also lists 26 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 2 Aug 2022; AzTrials last refreshed its copy on 28 Oct 2026.