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Understanding Pre-operative Activity Levels in Elderly Patients

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ClinicalTrials.gov Identifier: NCT03737903
Recruitment Status : Unknown
Verified November 2018 by Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : November 13, 2018
Last Update Posted : November 13, 2018
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust

Study Description
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Brief Summary:

The investigators aim to determine whether a wrist-worn accelerometer device is able to objectively measure physical activity, and whether it is an acceptable process for high-risk elderly patients prior to planned surgery. Accelerometers measure physical activity in 'counts' of activity, enabling them to record the total amount of activity in a given time period (e.g. number of steps per day), and also the time spent in various levels of intensity of activity. The investigators will ask study participants to wear an accelerometer around their wrist (like a wristwatch) for up to 14 days prior to their surgery. Participants will receive the same care as non-participants. Part of this routine medical care includes a preoperative review by a multidisciplinary team including specific personalised advice to optimise physical activity before surgery. The investigators will measure the impact that this existing intervention has on physical activity levels. Being more physically active is good for our health, and may be associated with a better recovery from surgery. In the future there may be methods of improving physical activity in the period of time before patients' surgery, which may improve their recovery from surgery.

In order to study this further, the investigators first need a robust and objective way of measuring physical activity. In current practice patients are asked to estimate how physically active they are on a day-to-day basis. This relies on how well they remember, and how good they are at getting it right and may not be accurate. The wrist-worn accelerometer is an objective method of measuring physical activity in patients, which not only offers greater understanding of the physical activity levels of elderly patients before a variety of operations, but also offers the opportunity to measure the impact of existing and potential future interventions to modify physical activity in the preoperative period.


Condition or disease
Surgery Physical Activity Aging

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Use of Wrist-worn Accelerometers to Measure Physical Activity in High-risk Elderly Patients
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Measuring physical activity, defined as daily average activity-related acceleration (expressed in relative gravity, milligravity) in high risk elderly patients in the preoperative period using wrist worn accelerometers. [ Time Frame: 2 weeks ]
    This will be measured using a wrist worn accelerometer device to measure daily average activity-related acceleration expressed in relative gravity, milligravity.


Secondary Outcome Measures :
  1. Objective measurement of baseline physical activity levels using a wrist worn triaxial accelerometer, across different surgical specialties, thereby obtaining data on the variation in physical activity, expressed in relative gravity (milligravity). [ Time Frame: 2 weeks ]
    Measurement of baseline physical activity levels using a wrist worn triaxial accelerometer, across different surgical specialties, thereby obtaining data on the variation in physical activity, expressed in relative gravity (milligravity).

  2. Measure total daily physical activity, expressed in relative gravity (milligravity), using a wrist-worn triaxial accelerometer, before and after current preoperative intervention occuring as part of routine medical care. [ Time Frame: 2 weeks ]
    Measure total daily physical activity, expressed in relative gravity (milligravity), using a wrist-worn triaxial accelerometer,for one week before and one week after current preoperative intervention occurring as part of routine medical care. This will measure any change in physical activity from baseline to one week post intervention (therefore measured over a total time period of 2 weeks) as part of routine medical care

  3. Correlation between objectively measured physical activity and patient reported physical activity [ Time Frame: 2 weeks ]
    To determine any correlation between measured physical activity (expressed in relative gravity, milligravity), and patient reported physical activity (expressed using the PASE score) measured using appropriate correlation statistics

  4. Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties. [ Time Frame: 2 weeks ]
    Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties, thereby obtaining data on the variation in physical activity measured by the Physical Activity Scale for the Elderly (PASE) score. PASE comprises measures of self-reported occupational, household, and leisure activities during a one-week period. Scores range from 0 to 400 with a higher score indicating a higher level of physical activity

  5. Determine participant compliance in wearing the accelerometer device [ Time Frame: 2 weeks ]
    This will be measured by recording the total wear time (in hours) of the device during the study period


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The investigators are aiming to recruit approximately 50 high-risk patients aged 65 years and above, prior to major or complex elective surgery.

"High-risk" is determined by Rockwood Clinical Frailty Score ≥4. Major or complex surgery is defined in NICE guideline (NG45).

Criteria

Inclusion Criteria:

  • Male or female aged 65 years or above
  • Rockwood frailty score of ≥4
  • Listed for elective major or complex surgery at Cambridge University Hospitals NHS Foundation Trust
  • Capacity to consent and complete activity questionnaires
  • Willing and able to wear accelerometer around wrist

Exclusion Criteria:

  • Does not meet the inclusion criteria
  • Participant refusal
  • PRIME clinic appointment scheduled less than 72hrs after the nurse led pre-assessment clinic
Contacts and Locations
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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): NCT03737903


Contacts
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Contact: Lisa Grimes 01223 274446 lag31@cam.ac.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambs, United Kingdom, CB20QQ
Contact: Ari Ercole, PhD    01223 217889      
Sponsors and Collaborators
Joanne Outtrim
University of Cambridge
Investigators
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Principal Investigator: Ari Ercole Cambridge University Hospitals NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joanne Outtrim, Senior Research Nurse, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03737903    
Other Study ID Numbers: A094782
238840 ( Other Identifier: IRAS Number )
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
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 Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust:
Frail elderly
Accelerometer
Preoperative assessment