Clinical trial NCT03964714: Monitoring Physical Activity in Acutely Hospitalized Elderly of 70 Years and Older
Official title: Monitoring Physical Activity in Acutely Hospitalized Elderly of 70 Years and Older
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: Acutely hospitalised
Elderly
Activity monitoring
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 165
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥70 years that are acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean number of minutes spent physically active (standing and walking) per day
timeFrame: Measured continuously from the day of inclusion (Day 0) until the day the subject is medically ready to be discharged from the hospital.
measure: Mean number of breaks in sedentary time (BST) per day
timeFrame: 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:
measure: Short Physical Performance Battery scores (summary and component scores)
timeFrame: Measured on the day of inclusion (Day 0)
measure: Activity Measure for Post-Acute Care (AM-PAC) Inpatient Basic Mobility short form score
timeFrame: Measured on the day of inclusion (Day 0)
measure: Age
timeFrame: Scored once on the day of inclusion (Day 0)
measure: Sex
timeFrame: Scored once on the day of inclusion (Day 0).
measure: Disability in activities of daily living (ADLs) two weeks prior to admission
timeFrame: Scored once the day of inclusion (Day 0).
measure: The use of ambulation assistive devices prior to admission
timeFrame: Scored on the day of inclusion (Day 0).
measure: Clinical diagnosis
timeFrame: 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.)
measure: Physiotherapy consulted during hospitalization
timeFrame: 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.)
Other outcomes:
measure: History of falls in the past six months
timeFrame: Once, on the day of inclusion (Day 0)
measure: Medical comorbidities
timeFrame: 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.)
measure: Length of stay
timeFrame: 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.)
measure: Discharge location
timeFrame: 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.)
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Antoine F Lenssen, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.