NCT03964714

Brief 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 hospitalization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

January 14, 2019

Last Update Submit

September 29, 2020

Conditions

Physical Activity

Keywords

Acutely hospitalisedElderlyActivity monitoring

Outcome Measures

Primary Outcomes (2)

  • 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 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 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)

    Measured on the day of inclusion (Day 0)

  • Activity Measure for Post-Acute Care (AM-PAC) Inpatient Basic Mobility short form score

    Measured on the day of inclusion (Day 0)

  • Age

    Scored once on the day of inclusion (Day 0)

  • Sex

    Scored once on the day of inclusion (Day 0).

  • Disability in activities of daily living (ADLs) two weeks prior to admission

    Scored once the day of inclusion (Day 0).

  • +3 more secondary outcomes

Other Outcomes (4)

  • History of falls in the past six months

    Once, on the day of inclusion (Day 0)

  • Medical comorbidities

    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.)

  • Length of stay

    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.)

  • +1 more other outcomes

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged ≥70 years that are acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MaastrichtUMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 18712640RESULT

  • Evensen 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.

    PMID: 28511639RESULT

  • Fisher 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.

    PMID: 21158744RESULT

  • Ostir 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.

    PMID: 23527951RESULT

  • Pedersen 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.

    PMID: 22972940RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Antoine F Lenssen, Prof., PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

May 28, 2019

Study Start

October 19, 2018

Primary Completion

March 23, 2019

Study Completion

March 23, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)