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Monitoring Physical Activity in Acutely Hospitalized Elderly of 70 Years and Older (MPA)

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ClinicalTrials.gov Identifier: NCT03964714
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease
Physical Activity

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.

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Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Physical Activity in Acutely Hospitalized Elderly of 70 Years and Older
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. Short Physical Performance Battery scores (summary and component scores) [ Time Frame: Measured on the day of inclusion (Day 0) ]
    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.

  2. Activity Measure for Post-Acute Care (AM-PAC) Inpatient Basic Mobility short form score [ Time Frame: Measured on the day of inclusion (Day 0) ]
    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).

  3. Age [ Time Frame: Scored once on the day of inclusion (Day 0) ]
    Categories 70-79, 80-89, ≥90 years

  4. Sex [ Time Frame: Scored once on the day of inclusion (Day 0). ]
    Male / Female

  5. Disability in activities of daily living (ADLs) two weeks prior to admission [ Time Frame: Scored once the day of inclusion (Day 0). ]
    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.

  6. The use of ambulation assistive devices prior to admission [ Time Frame: Scored on the day of inclusion (Day 0). ]
    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.

  7. 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.) ]
    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.

  8. 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.) ]
    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.


Other Outcome Measures:
  1. History of falls in the past six months [ Time Frame: Once, on the day of inclusion (Day 0) ]
    The number of falls in the last 6 months before hospital admission. Measured retrospectively by asking the patient the following question: Have you fallen once or more in the past six months? If yes, how many times? Question is asked by the researcher.

  2. Medical comorbidities [ 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.) ]
    Charlson Comorbidity Index (CCI). Comorbidities are reported by the physician in the electronic medical record. All comorbidities present in the period between admission and intended discharge are extracted by the researcher and used to calculate the Charlson Comorbidity Index.

  3. Length of stay [ 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.) ]
    Number of days from admission to the hospital to intended discharge (Defined as the day the patient is medically ready for discharge and is either discharged or staying for non-medical reasons.). Length of stay is retrieved from the electronic medical record.

  4. Discharge location [ 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.) ]
    Home, geriatric rehabilitation center, nursing home, other. As reported in the electronic medical record by the physician.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged ≥70 years that are acutely hospitalized in MUMC+ at the department of Internal and Geriatric Medicine.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964714


Contacts
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Contact: Hanneke C van Dijk - Huisman, MSc +31 433 ext 877146 hanneke.huisman@mumc.nl
Contact: Antoine F Lenssen, Prof., PhD +31 433 ext 877146 af.lenssen@mumc.nl

Locations
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Netherlands
MaastrichtUMC Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Antoine F Lenssen, Prof., PhD    +3143-3 ext 877146    af.lenssen@mumc.nl   
Contact: Hanneke C van Dijk - Huisman, MSc    +3143-3 ext 877146    hanneke.huisman@mumc.nl   
Sub-Investigator: Mandy Welters, BSc         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Antoine F Lenssen, Prof., PhD Maastricht University Medical Center
Publications of Results:
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03964714    
Other Study ID Numbers: NL65097.068.18
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Acutely hospitalised
Elderly
Activity monitoring