WeaknessNCT02757131
Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients
A study testing Ambulation in people with Weakness and Hospital Acquired Condition, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Bedrest and lack of mobility in the inpatient hospital setting hastens the functional decline of elderly patients and is associated with increased risk of complications such as falls, delirium, venous thrombosis, and skin breakdown. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Weakness, Hospital Acquired Condition
- What is being tested?
- Ambulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 60 years of age or older admitted as inpatients to floors G80, H80, H81 and G81 in the Medicine Institute, Cleveland Clinic Main Campus during the study time period
- Hospitalized for a medical illness
- Complete history and physical examination on file
- Physical therapy consult and 6-Clicks score between 16-20 a. This is based on a usual care assessment ordered by a physician that will happen prior to any study recruitment - it is entirely independent of the study
Who cannot join
- Observational status
- Admission to ICU
- Surgical patients
- Patients diagnosed with: decompensated heart failure, unstable angina, other medical conditions precluding participation in exercise/ambulation
- Comfort care measures only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients: A Randomized, Controlled Trial
Bedrest and lack of mobility in the inpatient hospital setting hastens the functional decline of elderly patients and is associated with increased risk of complications such as falls, delirium, venous thrombosis, and skin breakdown. These adverse health effects drive increased cost as patients spend additional time in both the acute (hospital) and post-acute care settings. Physical activity is thus widely recognized as an important factor for improving outcomes in hospitalized patients; however, numerous challenges to its implementation exist. Specifically, although it has been found that with small increases in physical activity such as increasing number of steps by only 600 daily for inpatients, length of stay can be reduced by nearly 2 days, usual care in many hospitals, including the Cleveland Clinic, does not include exercise, and physicians do not all regularly order physical activity for their hospitalized patients. Even when activity is recommended or ordered, compliance and execution of the orders has been spotty and/or negligible. It is therefore clear that the current system for the provision of ambulation is ineffective. The investigators hypothesize that a graded protocol of ambulation which can be implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily will provide significant benefit to patients without the labor and cost requirements of full-time nursing and physical therapy expertise. The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in elderly inpatients. The primary hypothesis is that an ambulator-assisted intervention for hospitalized elderly inpatients will prove feasible and may result in improved hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital. This study will provide pilot data for a larger randomized trial.
Read the detailed description
Specific Aims
Aim 1: To determine the feasibility of implementing an ambulator-assisted exercise intervention in elderly patients on an inpatient medicine service.
The investigators will work closely with the physical therapy team to develop a graded ambulation protocol that can be implemented multiple times daily per enrolled patient by a PCNA. Investigators will work closely with the medicine units to recruit eligible patients and assess protocol implementation including recruitment, patient cooperation, and scheduling.
Aim 2: To determine the effects of an ambulator-assisted exercise intervention on discharge disposition, length of stay and cost.
The investigators will measure the proportion of patients in the intervention and usual care group who are discharged to home vs. acute rehabilitation facilities. Length of stay and cost will be obtained from hospital billing records.
Research Strategy
The investigators propose the development of a feasible program to assist in improving the physical capacity of elderly inpatients. Such improvements may translate to cost savings in the form of decreased length of stay, improved discharge disposition, and fewer hospital-related complications, but establishing that is not the purpose of this study. The investigators propose that the most feasible and cost-effective implementation of such a program will utilize a patient care nursing assistant (PCNA) dedicated to carrying out a graded ambulation protocol in eligible patients multiple times daily. A simple and standardized protocol for ambulation will reduce the need for the expertise of a dedicated physical therapist. Additionally, utilizing an existing mechanism for assessing baseline functional capacity, the 6-Clicks score, will eliminate the time and personnel requirements for evaluation of patient eligibility. This score has been validated as a mechanism to assess patient mobility limitations in an acute care setting and is currently used on all patients seen by physical therapy on the inpatient medicine services.
This pilot study will enable the investigators to identify which patients would tolerate the intervention and what degree of participation would be meaningful to improve the outcomes measured. The study will begin by enrolling patients with 6-Clicks scores of 16-20, as these patients will experience the greatest benefit from an ambulation protocol. At present, such patients do not receive any PT intervention and ambulation by nurses occurs only sporadically as time allows. Additionally, the pilot will help to bring clarity to the direct impact of aggressive mobilization of medical inpatients on important outcomes that are directly tied to healthcare cost. Results of this work will inform feasibility and power calculations for a larger randomized trial. Results of that trial could directly impact the approach to the medical inpatient in terms of prioritizing and resourcing mobilization strategies.
Preliminary findings from this pilot study demonstrating the feasibility of a dedicated ambulator-assisted physical activity protocol and its potential impact on hospital outcomes will provide the justification for external funding of a larger randomized clinical trial. Lessons learned from the pilot study will allow us to optimize the ambulation protocol and target population for a larger study. Such a study would investigate the effect of the ambulator-assisted physical activity protocol on patient mobility associated health care costs. This work could shift the current paradigm that aggressive mobilization is reserved for post-acute care settings and could serve as a model for improving the value of care provided to elderly patients in acute care facilities.
- Conditions
- Weakness, Hospital Acquired Condition
- Being tested
- Ambulation
- Keywords
- Mobility, Elderly, Hospitalized patient
- Medical subject headings
- Asthenia, Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbulationOther
Patients randomized to the intervention group will be asked to participate in the ambulation protocol outlined by the PT staff 3 times daily under the supervision of the dedicated ambulator PCNA. This protocol will involve four exercise levels (mobilization, standing, walking, stairs) that may be implemented depending on the current physical capacity of the patient. The cohort of patients randomized to "ambulator protocol" will also receive the usual care by primary nursing.
In an effort to best characterize mobility in these patients, the team will collect Braden Scale Activity data from the electronic health record, and provide each patient a mobility tracking device to directly record daily steps taken while the patient is in the hospital. Daily step counts will be collected on a weekly basis from each device. The Braden Scale is entered by nursing on each patient at least daily and measures current activity level on a 4-point scale.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized to the intervention group will be asked to participate in the ambulation protocol outlined by the Physical Therapy (PT) staff 3 times daily under the supervision of the dedicated ambulator PCNA.
The ambulator will be trained by the physical therapy team on how to implement the protocol prior to initiation of the study. Receives: Other: Ambulation |
| Control | No intervention | The cohort of patients randomized to "usual care" will not be seen by the dedicated ambulator, but will not otherwise be restricted in nursing's baseline ability to execute nursing specific recommendations placed by the PT team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge disposition from hospitalization - from electronic health record
The investigators will track the care setting patients are discharged to from the inpatient stay. This will include home, home with home health care, skilled nursing facility, acute rehab, nursing home, hospice
Measured: Will be measured at time of discharge for each patient through study completion, up to six weeks
Length of stay in days for participant's hospitalization
Time, in days, elapsed from patient admission to discharge
Measured: Will be measured at the time of discharge for each patient through study completion, up to six weeks
Secondary outcomes (6)
Patient in-hospital mortality
Measured: Will be measured for the episode of care associated with the admission the patient was enrolled in the study, up to six weeks
Admission to Intensive care unit after initiation of intervention - from electronic health record
Participants enrolled in the study will be followed and if their care is escalated to an intensive care unit, the investigators will track
Measured: Will be measured at patient level at the completion of each patient discharge, up to six weeks
Participant inpatient falls - binary yes/no extracted from the safety event reporting system which closely tracks all inpatient falls
Measured: Will be measured at the time of discharge for the patient and will include any fall during the index admission
New onset of stroke, Deep Vein Thrombosis, Pulmonary embolus or pneumonia during hospitalization as determined by billing codes for participants
Participants with billing codes for the above conditions that are not present on admission will be included in the outcome measure.
Measured: Will be measured at patient level for each admission and will end at discharge, up to six weeks
Readmission within 30 days
Measured: 30 days after discharge
Change in 6-Clicks score from admission to discharge - as measured by the physical therapy team with each visit - this is extracted from our electronic health record
The 6-clicks score is a validated marker of mobility for inpatients
Measured: Will be measured at patient level for each admission and will end at discharge, up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for WeaknessStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Hamilton, The Cleveland Clinic
- Investigators
- Aaron Hamilton, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757131
- Sponsor's protocol ID
- 16-335
- Status last verified
- Aug 2017
- First submitted
- 19 Apr 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
National Center for Health Statistics (US). Health, United States, 2013: With Special Feature on Prescription Drugs. Hyattsville (MD): National Center for Health Statistics (US); 2014 May. Report No.: 2014-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK209224/
PubMed 24967476Corcoran PJ. Use it or lose it--the hazards of bed rest and inactivity. West J Med. 1991 May;154(5):536-8.
PubMed 1866946Zisberg A, Shadmi E, Sinoff G, Gur-Yaish N, Srulovici E, Admi H. Low mobility during hospitalization and functional decline in older adults. J Am Geriatr Soc. 2011 Feb;59(2):266-73. doi: 10.1111/j.1532-5415.2010.03276.x.
PubMed 21314647Gillick MR, Serrell NA, Gillick LS. Adverse consequences of hospitalization in the elderly. Soc Sci Med. 1982;16(10):1033-8. doi: 10.1016/0277-9536(82)90175-7.
PubMed 6955965Hirsch 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 2123911Sager MA, Franke T, Inouye SK, Landefeld CS, Morgan TM, Rudberg MA, Sebens H, Winograd CH. Functional outcomes of acute medical illness and hospitalization in older persons. Arch Intern Med. 1996 Mar 25;156(6):645-52.
PubMed 8629876Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
PubMed 10737280Campbell AJ, Borrie MJ, Spears GF. Risk factors for falls in a community-based prospective study of people 70 years and older. J Gerontol. 1989 Jul;44(4):M112-7. doi: 10.1093/geronj/44.4.m112.
PubMed 2738307Fisher SR, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med. 2010 Nov 22;170(21):1942-3. doi: 10.1001/archinternmed.2010.422. No abstract available.
PubMed 21098357Graf C. Functional decline in hospitalized older adults. Am J Nurs. 2006 Jan;106(1):58-67, quiz 67-8. doi: 10.1097/00000446-200601000-00032.
PubMed 16481783Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.
PubMed 15031239Lazarus BA, Murphy JB, Coletta EM, McQuade WH, Culpepper L. The provision of physical activity to hospitalized elderly patients. Arch Intern Med. 1991 Dec;151(12):2452-6.
PubMed 1747003McVey LJ, Becker PM, Saltz CC, Feussner JR, Cohen HJ. Effect of a geriatric consultation team on functional status of elderly hospitalized patients. A randomized, controlled clinical trial. Ann Intern Med. 1989 Jan 1;110(1):79-84. doi: 10.7326/0003-4819-110-1-79.
PubMed 2642284Said CM, Morris ME, Woodward M, Churilov L, Bernhardt J. Enhancing physical activity in older adults receiving hospital based rehabilitation: a phase II feasibility study. BMC Geriatr. 2012 Jun 8;12:26. doi: 10.1186/1471-2318-12-26.
PubMed 22676723Inouye SK, Wagner DR, Acampora D, Horwitz RI, Cooney LM Jr, Tinetii ME. A controlled trial of a nursing-centered intervention in hospitalized elderly medical patients: the Yale Geriatric Care Program. J Am Geriatr Soc. 1993 Dec;41(12):1353-60. doi: 10.1111/j.1532-5415.1993.tb06487.x.
PubMed 8227919
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02757131
- Acronym / sponsor ID
- 16-335
- Conditions
- Weakness, Hospital Acquired Condition
- Keywords
- Mobility, Elderly, Hospitalized patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Apr 2016 (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.
Bedrest and lack of mobility in the inpatient hospital setting hastens the functional decline of elderly patients and is associated with increased risk of complications such as falls, delirium, venous thrombosis, and skin breakdown. These adverse health effects drive increased cost as patients spend additional time in both the acute (hospital) and post-acute care settings. Physical activity is thus widely recognized as an important factor for improving outcomes in hospitalized patients; however, numerous challenges to its implementation exist. Specifically, although it has been found that with small increases in physical activity such as increasing number of steps by only 600 daily for inpatients, length of stay can be reduced by nearly 2 days, usual care in many hospitals, including the Cleveland Clinic, does not include exercise, and physicians do not all regularly order physical activity for their hospitalized patients. Even when activity is recommended or ordered, compliance and execution of the orders has been spotty and/or negligible. It is therefore clear that the current system for the provision of ambulation is ineffective. The investigators hypothesize that a graded protocol of ambulation which can be implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily will provide significant benefit to patients without the labor and cost requirements of full-time nursing and physical therapy expertise. The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in elderly inpatients. The primary hypothesis is that an ambulator-assisted intervention for hospitalized elderly inpatients will prove feasible and may result in improved hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital. This study will provide pilot data for a larger randomized trial.
Detailed description
Specific Aims
Aim 1: To determine the feasibility of implementing an ambulator-assisted exercise intervention in elderly patients on an inpatient medicine service.
The investigators will work closely with the physical therapy team to develop a graded ambulation protocol that can be implemented multiple times daily per enrolled patient by a PCNA. Investigators will work closely with the medicine units to recruit eligible patients and assess protocol implementation including recruitment, patient cooperation, and scheduling.
Aim 2: To determine the effects of an ambulator-assisted exercise intervention on discharge disposition, length of stay and cost.
The investigators will measure the proportion of patients in the intervention and usual care group who are discharged to home vs. acute rehabilitation facilities. Length of stay and cost will be obtained from hospital billing records.
Research Strategy
The investigators propose the development of a feasible program to assist in improving the physical capacity of elderly inpatients. Such improvements may translate to cost savings in the form of decreased length of stay, improved discharge disposition, and fewer hospital-related complications, but establishing that is not the purpose of this study. The investigators propose that the most feasible and cost-effective implementation of such a program will utilize a patient care nursing assistant (PCNA) dedicated to carrying out a graded ambulation protocol in eligible patients multiple times daily. A simple and standardized protocol for ambulation will reduce the need for the expertise of a dedicated physical therapist. Additionally, utilizing an existing mechanism for assessing baseline functional capacity, the 6-Clicks score, will eliminate the time and personnel requirements for evaluation of patient eligibility. This score has been validated as a mechanism to assess patient mobility limitations in an acute care setting and is currently used on all patients seen by physical therapy on the inpatient medicine services.
This pilot study will enable the investigators to identify which patients would tolerate the intervention and what degree of participation would be meaningful to improve the outcomes measured. The study will begin by enrolling patients with 6-Clicks scores of 16-20, as these patients will experience the greatest benefit from an ambulation protocol. At present, such patients do not receive any PT intervention and ambulation by nurses occurs only sporadically as time allows. Additionally, the pilot will help to bring clarity to the direct impact of aggressive mobilization of medical inpatients on important outcomes that are directly tied to healthcare cost. Results of this work will inform feasibility and power calculations for a larger randomized trial. Results of that trial could directly impact the approach to the medical inpatient in terms of prioritizing and resourcing mobilization strategies.
Preliminary findings from this pilot study demonstrating the feasibility of a dedicated ambulator-assisted physical activity protocol and its potential impact on hospital outcomes will provide the justification for external funding of a larger randomized clinical trial. Lessons learned from the pilot study will allow us to optimize the ambulation protocol and target population for a larger study. Such a study would investigate the effect of the ambulator-assisted physical activity protocol on patient mobility associated health care costs. This work could shift the current paradigm that aggressive mobilization is reserved for post-acute care settings and could serve as a model for improving the value of care provided to elderly patients in acute care facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AmbulationPatients randomized to the intervention group will be asked to participate in the ambulation protocol outlined by the Physical Therapy (PT) staff 3 times daily under the supervision of the dedicated ambulator PCNA. The ambulator will be trained by the physical therapy team on how to implement the protocol prior to initiation of the study. |
| Control | No intervention | –The cohort of patients randomized to "usual care" will not be seen by the dedicated ambulator, but will not otherwise be restricted in nursing's baseline ability to execute nursing specific recommendations placed by the PT team. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women 60 years of age or older admitted as inpatients to floors G80, H80, H81 and G81 in the Medicine Institute, Cleveland Clinic Main Campus during the study time period
- Hospitalized for a medical illness
- Complete history and physical examination on file
- Physical therapy consult and 6-Clicks score between 16-20 a. This is based on a usual care assessment ordered by a physician that will happen prior to any study recruitment - it is entirely independent of the study
Key exclusion criteria (5 listed)
- Observational status
- Admission to ICU
- Surgical patients
- Patients diagnosed with: decompensated heart failure, unstable angina, other medical conditions precluding participation in exercise/ambulation
- Comfort care measures only
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 |
|---|---|---|
| AmbulationPatients randomized to the intervention group will be asked to participate in the ambulation protocol outlined by the PT staff 3 times daily under the supervision of the dedicated ambulator PCNA. This protocol will involve four exercise levels (mobilization, standing, walking, stairs) that may be implemented depending on the current physical capacity of the patient. The cohort of patients randomized to "ambulator protocol" will also receive the usual care by primary nursing. In an effort to best characterize mobility in these patients, the team will collect Braden Scale Activity data from the electronic health record, and provide each patient a mobility tracking device to directly record daily steps taken while the patient is in the hospital. Daily step counts will be collected on a weekly basis from each device. The Braden Scale is entered by nursing on each patient at least daily and measures current activity level on a 4-point scale. | Other | Intervention |
Primary outcome
Discharge disposition from hospitalization - from electronic health record
Time frame: Will be measured at time of discharge for each patient through study completion, up to six weeks
The investigators will track the care setting patients are discharged to from the inpatient stay. This will include home, home with home health care, skilled nursing facility, acute rehab, nursing home, hospice
Length of stay in days for participant's hospitalization
Time frame: Will be measured at the time of discharge for each patient through study completion, up to six weeks
Time, in days, elapsed from patient admission to discharge
6 secondary outcomes
Patient in-hospital mortality
Time frame: Will be measured for the episode of care associated with the admission the patient was enrolled in the study, up to six weeks
Admission to Intensive care unit after initiation of intervention - from electronic health record
Time frame: Will be measured at patient level at the completion of each patient discharge, up to six weeks
Participant inpatient falls - binary yes/no extracted from the safety event reporting system which closely tracks all inpatient falls
Time frame: Will be measured at the time of discharge for the patient and will include any fall during the index admission
New onset of stroke, Deep Vein Thrombosis, Pulmonary embolus or pneumonia during hospitalization as determined by billing codes for participants
Time frame: Will be measured at patient level for each admission and will end at discharge, up to six weeks
Readmission within 30 days
Time frame: 30 days after discharge
Change in 6-Clicks score from admission to discharge - as measured by the physical therapy team with each visit - this is extracted from our electronic health record
Time frame: Will be measured at patient level for each admission and will end at discharge, up to six weeks
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 10 Aug 2017.
- Background: PubMed 24967476National Center for Health Statistics (US). Health, United States, 2013: With Special Feature on Prescription Drugs. Hyattsville (MD): National Center for Health Statistics (US); 2014 May. Report No.: 2014-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK209224/
- Background: PubMed 1866946Corcoran PJ. Use it or lose it--the hazards of bed rest and inactivity. West J Med. 1991 May;154(5):536-8.
- Background: PubMed 21314647Zisberg A, Shadmi E, Sinoff G, Gur-Yaish N, Srulovici E, Admi H. Low mobility during hospitalization and functional decline in older adults. J Am Geriatr Soc. 2011 Feb;59(2):266-73. doi: 10.1111/j.1532-5415.2010.03276.x.
- Background: PubMed 6955965Gillick MR, Serrell NA, Gillick LS. Adverse consequences of hospitalization in the elderly. Soc Sci Med. 1982;16(10):1033-8. doi: 10.1016/0277-9536(82)90175-7.
- 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 8629876Sager MA, Franke T, Inouye SK, Landefeld CS, Morgan TM, Rudberg MA, Sebens H, Winograd CH. Functional outcomes of acute medical illness and hospitalization in older persons. Arch Intern Med. 1996 Mar 25;156(6):645-52.
- Background: PubMed 10737280Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
- Background: PubMed 2738307Campbell AJ, Borrie MJ, Spears GF. Risk factors for falls in a community-based prospective study of people 70 years and older. J Gerontol. 1989 Jul;44(4):M112-7. doi: 10.1093/geronj/44.4.m112.
- Background: PubMed 21098357Fisher SR, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med. 2010 Nov 22;170(21):1942-3. doi: 10.1001/archinternmed.2010.422. No abstract available.
- Background: PubMed 16481783Graf C. Functional decline in hospitalized older adults. Am J Nurs. 2006 Jan;106(1):58-67, quiz 67-8. doi: 10.1097/00000446-200601000-00032.
- Background: PubMed 15031239Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.
- Background: PubMed 1747003Lazarus BA, Murphy JB, Coletta EM, McQuade WH, Culpepper L. The provision of physical activity to hospitalized elderly patients. Arch Intern Med. 1991 Dec;151(12):2452-6.
- Individual participant dataSharing planned: No
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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.
Aaron Hamilton, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulation in people with Weakness and Hospital Acquired Condition, run by The Cleveland Clinic at 1 site in United States.
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 4 inclusion and 5 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 10 Aug 2017. 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 United States. 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?
Discharge disposition from hospitalization - from electronic health record (time frame: Will be measured at time of discharge for each patient through study completion, up to six weeks). 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 NCT02757131, which also lists 18 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 10 Aug 2017.