Physical ActivityMPANCT03964714
Monitoring Physical Activity in Acutely Hospitalized Elderly of 70 Years and Older
An observational study of Physical Activity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study aims to create reference values regarding the amount of physical activity of acutely hospitalized elderly ≥70 years during hospitalization and aims to create a prediction model in order predict the probability of low amounts of physical activity of acutely hospitalized elderly ≥70 years during… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Physical Activity
- How many people
- 165 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Oct 2018to 23 Mar 2020
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged ≥70 years that are acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine.
Who may be able to join
- 70 years or older
- Acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine
- Sufficient understanding of the Dutch language
- Living at home before hospitalization
- Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC >3)
Who cannot join
- A life expectancy of less than three months as assessed by the attending physician
- Incapacitated subjects
- The inability to follow instructions due to cognitive problems or severe agitation
- A contraindication to wearing an accelerometer, fixated by a hypoallergenic plaster, on the upper leg (such as active bilateral upper leg infection, severe edema or bilateral transfemoral amputation)
- (Re)admittance to the intensive care unit
- Presence of contraindications to walking as assessed by the attending physician
- Previous participation to this study
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to create reference values regarding the amount of physical activity of acutely hospitalized elderly ≥70 years during hospitalization and aims to create a prediction model in order predict the probability of low amounts of physical activity of acutely hospitalized elderly ≥70 years during hospitalization.
Read the detailed description
Rationale: Despite numerous studies supporting adverse outcomes associated with low physical activity (PA), there is insufficient insight in the amount of PA of acutely hospitalized Dutch elderly ≥ 70 years. PA can be objectively measured by accelerometers, but it is time consuming and expensive to provide every patient with an accelerometer. We need to be able to predict which elderly patients are likely to spend low amounts of physical activity during hospitalization. Because of the association between PA and functional decline it is expected that functional assessment tests like the Short Physical Performance Battery (SPPB) or Activity Measure for Post-Acute Care (AM-PAC) could be used as a screening tool to determine which patients will be at risk of low amounts of PA.
Objective: The primary objectives of this study are: 1) To assess the amount of PA of acutely hospitalized elderly ≥70 years during hospitalization and to create reference values regarding the amount of time patients are standing and walking per day and the number of breaks in sedentary time (BST) per day. 2) To be able to predict the probability of low amounts of physical activity during hospitalization for acutely hospitalized elderly ≥70 years.
Study design: This is a single center, observational, prospective cohort study.
Study population: 165 patients aged ≥70 years that are acutely hospitalized at the department of internal and geriatric medicine in the Maastricht University Medical Center (MUMC+).
Method: PA will be monitored with an accelerometer from inclusion (t0) until the day of intended discharge (t1). A functional assessment (SPPB and AM-PAC) will be performed at t0. Medical and demographic data will be obtained from the medical record and by patient report.
Main study parameters/endpoints: Mean number of minutes spent physically active (standing and walking) per day, dichotomized into a low and high amount of time spent physically active per day during hospitalization for the prediction model. Mean number of BST per day, dichotomized into a low and high number of BST per day during hospitalization for the prediction model.
- Conditions
- Physical Activity
- Keywords
- Acutely hospitalised, Elderly, Activity monitoring
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of minutes spent physically active (standing and walking) per day
Defined as the total number of minutes standing and walking divided by the total number of valid measurement days in the period between inclusion and (intended) discharge. In order to create a prediction model, this will be dichotomized into a low and high amount of time spent physically active per day during hospitalization. As the estimated event rate of a high amount of time spent physically active per day during hospitalization is 50%, the cut-off value between a low and high amount of time spent physically active will be defined by dividing the cohort at the median.
Measured: Measured continuously from the day of inclusion (Day 0) until the day the subject is medically ready to be discharged from the hospital.
Mean number of breaks in sedentary time (BST) per day
Defined as the total number of BST divided by the total number of valid measurement days in the period between inclusion and (intended) discharge. A BST is defined as any transition from being sedentary (lying or sitting) to being physically active (standing or walking).
In order to create a prediction model, this will be dichotomized into a low and high number of breaks in sedentary time per day during hospitalization. As the estimated event rate of a high number of breaks in sedentary time per day during hospitalization is 50%, the cut-off value between a low and high number of breaks in sedentary time will be defined by dividing the cohort at the median.
Measured: Measured continuously from the day of inclusion (Day 0) until the day the subject is medically ready to be discharged from the hospital.
Secondary outcomes (8)
Short Physical Performance Battery scores (summary and component scores)
Summary score on the scale: 0-12 points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 4 meter and time to rise from a chair and return to the seated position five times. Component scores (0-4) for the three categories are measured as well.
Measured: Measured on the day of inclusion (Day 0)
Activity Measure for Post-Acute Care (AM-PAC) Inpatient Basic Mobility short form score
The AM-PAC and provides a transparent measure of patients' capabilities in functional mobility during hospitalization. It measures the following daily activities: turning in bed, sitting down and standing up, moving from lying to sitting position, moving from a bed to a chair, walking and climbing stairs (6-24 points).
Measured: Measured on the day of inclusion (Day 0)
Age
Categories 70-79, 80-89, ≥90 years
Measured: Scored once on the day of inclusion (Day 0)
Sex
Male / Female
Measured: Scored once on the day of inclusion (Day 0).
Disability in activities of daily living (ADLs) two weeks prior to admission
Number of disabilities on the Katz Index of Independence in Activities of Daily Living (Katz ADL). The Katz ADL measures the patient's ability to perform ADL independently. It is a dichotomous rating (dependant / independent) of six ADL functions, bathing, dressing, toileting, transferring, continence and feeding. It rates the level of independence or dependence in these tasks and is categorized by the amount of assistance needed to complete the task. The researcher will ask the patient how much assistance was needed to complete the tasks 2 weeks prior to admission.
Measured: Scored once the day of inclusion (Day 0).
The use of ambulation assistive devices prior to admission
Yes/No. If yes, specify type of walking aid used prior to admission. The use of ambulation assistive device prior to admission is asked by the researcher.
Measured: Scored on the day of inclusion (Day 0).
Clinical diagnosis
Clinical diagnosis as reported in the electronic medical record by the physician. The last reported clinical diagnoses by the physician before intended discharge will be extracted.
Measured: On day of intended discharge from hospital, estimated up to 1 month. (Intended discharge is defined as the day the patient is medically ready for discharge and is either discharged or staying for non-medical reasons.)
Physiotherapy consulted during hospitalization
Did the patient receive one or more sessions of physiotherapy between inclusion and intended discharge? (Yes / No). All sessions will be reported by the physical therapist in the electronic medical record.
Measured: On day of intended discharge from hospital, estimated up to 1 month. (Intended discharge is defined as the day the patient is medically ready for discharge and is either discharged or staying for non-medical reasons.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start19 Oct 2018
- Primary completion23 Mar 2019
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine F Lenssen, Prof., PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964714
- Sponsor's protocol ID
- NL65097.068.18
- Acronym
- MPA
- Status last verified
- Sep 2020
- First submitted
- 14 Jan 2019
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown CJ, Roth DL, Allman RM. Validation of use of wireless monitors to measure levels of mobility during hospitalization. J Rehabil Res Dev. 2008;45(4):551-8. doi: 10.1682/jrrd.2007.06.0086.
PubMed 18712640Evensen S, Sletvold O, Lydersen S, Taraldsen K. Physical activity among hospitalized older adults - an observational study. BMC Geriatr. 2017 May 16;17(1):110. doi: 10.1186/s12877-017-0499-z.
PubMed 28511639Fisher SR, Goodwin JS, Protas EJ, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Ambulatory activity of older adults hospitalized with acute medical illness. J Am Geriatr Soc. 2011 Jan;59(1):91-5. doi: 10.1111/j.1532-5415.2010.03202.x. Epub 2010 Dec 16.
PubMed 21158744Ostir GV, Berges IM, Kuo YF, Goodwin JS, Fisher SR, Guralnik JM. Mobility activity and its value as a prognostic indicator of survival in hospitalized older adults. J Am Geriatr Soc. 2013 Apr;61(4):551-7. doi: 10.1111/jgs.12170. Epub 2013 Mar 25.
PubMed 23527951Pedersen MM, Bodilsen AC, Petersen J, Beyer N, Andersen O, Lawson-Smith L, Kehlet H, Bandholm T. Twenty-four-hour mobility during acute hospitalization in older medical patients. J Gerontol A Biol Sci Med Sci. 2013 Mar;68(3):331-7. doi: 10.1093/gerona/gls165. Epub 2012 Sep 12.
PubMed 22972940
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Physical Activity in Acutely Hospitalized Elderly of 70 Years and Older
- ClinicalTrials.gov ID
- NCT03964714
- Acronym / sponsor ID
- MPA / NL65097.068.18
- Conditions
- Physical Activity
- Keywords
- Acutely hospitalised, Elderly, Activity monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 28 May 2019 (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.
This study aims to create reference values regarding the amount of physical activity of acutely hospitalized elderly ≥70 years during hospitalization and aims to create a prediction model in order predict the probability of low amounts of physical activity of acutely hospitalized elderly ≥70 years during hospitalization.
Detailed description
Rationale: Despite numerous studies supporting adverse outcomes associated with low physical activity (PA), there is insufficient insight in the amount of PA of acutely hospitalized Dutch elderly ≥ 70 years. PA can be objectively measured by accelerometers, but it is time consuming and expensive to provide every patient with an accelerometer. We need to be able to predict which elderly patients are likely to spend low amounts of physical activity during hospitalization. Because of the association between PA and functional decline it is expected that functional assessment tests like the Short Physical Performance Battery (SPPB) or Activity Measure for Post-Acute Care (AM-PAC) could be used as a screening tool to determine which patients will be at risk of low amounts of PA.
Objective: The primary objectives of this study are: 1) To assess the amount of PA of acutely hospitalized elderly ≥70 years during hospitalization and to create reference values regarding the amount of time patients are standing and walking per day and the number of breaks in sedentary time (BST) per day. 2) To be able to predict the probability of low amounts of physical activity during hospitalization for acutely hospitalized elderly ≥70 years.
Study design: This is a single center, observational, prospective cohort study.
Study population: 165 patients aged ≥70 years that are acutely hospitalized at the department of internal and geriatric medicine in the Maastricht University Medical Center (MUMC+).
Method: PA will be monitored with an accelerometer from inclusion (t0) until the day of intended discharge (t1). A functional assessment (SPPB and AM-PAC) will be performed at t0. Medical and demographic data will be obtained from the medical record and by patient report.
Main study parameters/endpoints: Mean number of minutes spent physically active (standing and walking) per day, dichotomized into a low and high amount of time spent physically active per day during hospitalization for the prediction model. Mean number of BST per day, dichotomized into a low and high number of BST per day during hospitalization for the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged ≥70 years that are acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine.
Key inclusion criteria (5 listed)
- 70 years or older
- Acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine
- Sufficient understanding of the Dutch language
- Living at home before hospitalization
- Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC >3)
Key exclusion criteria (7 listed)
- A life expectancy of less than three months as assessed by the attending physician
- Incapacitated subjects
- The inability to follow instructions due to cognitive problems or severe agitation
- A contraindication to wearing an accelerometer, fixated by a hypoallergenic plaster, on the upper leg (such as active bilateral upper leg infection, severe edema or bilateral transfemoral amputation)
- (Re)admittance to the intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean number of minutes spent physically active (standing and walking) per day
Time frame: Measured continuously from the day of inclusion (Day 0) until the day the subject is medically ready to be discharged from the hospital.
Defined as the total number of minutes standing and walking divided by the total number of valid measurement days in the period between inclusion and (intended) discharge. In order to create a prediction model, this will be dichotomized into a low and high amount of time spent physically active per day during hospitalization. As the estimated event rate of a high amount of time spent physically active per day during hospitalization is 50%, the cut-off value between a low and high amount of time spent physically active will be defined by dividing the cohort at the median.
Mean number of breaks in sedentary time (BST) per day
Time frame: Measured continuously from the day of inclusion (Day 0) until the day the subject is medically ready to be discharged from the hospital.
Defined as the total number of BST divided by the total number of valid measurement days in the period between inclusion and (intended) discharge. A BST is defined as any transition from being sedentary (lying or sitting) to being physically active (standing or walking). In order to create a prediction model, this will be dichotomized into a low and high number of breaks in sedentary time per day during hospitalization. As the estimated event rate of a high number of breaks in sedentary time per day during hospitalization is 50%, the cut-off value between a low and high number of breaks in sedentary time will be defined by dividing the cohort at the median.
8 secondary outcomes
Short Physical Performance Battery scores (summary and component scores)
Time frame: Measured on the day of inclusion (Day 0)
Activity Measure for Post-Acute Care (AM-PAC) Inpatient Basic Mobility short form score
Time frame: Measured on the day of inclusion (Day 0)
Age
Time frame: Scored once on the day of inclusion (Day 0)
Sex
Time frame: Scored once on the day of inclusion (Day 0).
Disability in activities of daily living (ADLs) two weeks prior to admission
Time frame: Scored once the day of inclusion (Day 0).
The use of ambulation assistive devices prior to admission
Time frame: Scored on the day of inclusion (Day 0).
Clinical diagnosis
Time frame: On day of intended discharge from hospital, estimated up to 1 month. (Intended discharge is defined as the day the patient is medically ready for discharge and is either discharged or staying for non-medical reasons.)
Physiotherapy consulted during hospitalization
Time frame: On day of intended discharge from hospital, estimated up to 1 month. (Intended discharge is defined as the day the patient is medically ready for discharge and is either discharged or staying for non-medical reasons.)
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 30 Sep 2020.
- Results publication: PubMed 18712640Brown CJ, Roth DL, Allman RM. Validation of use of wireless monitors to measure levels of mobility during hospitalization. J Rehabil Res Dev. 2008;45(4):551-8. doi: 10.1682/jrrd.2007.06.0086.
- Results publication: PubMed 28511639Evensen S, Sletvold O, Lydersen S, Taraldsen K. Physical activity among hospitalized older adults - an observational study. BMC Geriatr. 2017 May 16;17(1):110. doi: 10.1186/s12877-017-0499-z.
- Results publication: PubMed 21158744Fisher SR, Goodwin JS, Protas EJ, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Ambulatory activity of older adults hospitalized with acute medical illness. J Am Geriatr Soc. 2011 Jan;59(1):91-5. doi: 10.1111/j.1532-5415.2010.03202.x. Epub 2010 Dec 16.
- Results publication: PubMed 23527951Ostir GV, Berges IM, Kuo YF, Goodwin JS, Fisher SR, Guralnik JM. Mobility activity and its value as a prognostic indicator of survival in hospitalized older adults. J Am Geriatr Soc. 2013 Apr;61(4):551-7. doi: 10.1111/jgs.12170. Epub 2013 Mar 25.
- Results publication: PubMed 22972940Pedersen MM, Bodilsen AC, Petersen J, Beyer N, Andersen O, Lawson-Smith L, Kehlet H, Bandholm T. Twenty-four-hour mobility during acute hospitalization in older medical patients. J Gerontol A Biol Sci Med Sci. 2013 Mar;68(3):331-7. doi: 10.1093/gerona/gls165. Epub 2012 Sep 12.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
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.
Antoine F Lenssen, Prof., PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 7 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 30 Sep 2020. 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 Netherlands. 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?
Mean number of minutes spent physically active (standing and walking) per day (time frame: Measured continuously from the day of inclusion (Day 0) until the day the subject is medically ready to be discharged from the hospital.). 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 NCT03964714, which also lists 5 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 30 Sep 2020.