Understanding Pre-operative Activity Levels in Elderly Patients

Preoperative Use of Wrist-worn Accelerometers to Measure Physical Activity in High-risk Elderly Patients

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.

Study Overview

• Status: Unknown
• Conditions: Physical Activity; Aging; Surgery

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United Kingdom
  • Cambs
    • Cambridge, Cambs, United Kingdom, CB20QQ
      • Recruiting
      • Cambridge University Hospitals NHS Foundation Trust
      • Contact: Ari Ercole, PhD; Phone Number: 01223 217889

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This will be measured using a wrist worn accelerometer device to measure daily average activity-related acceleration expressed in relative gravity, milligravity.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 weeks
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.	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	2 weeks
Correlation between objectively measured physical activity and patient reported physical activity	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	2 weeks
Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties.	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	2 weeks
Determine participant compliance in wearing the accelerometer device	This will be measured by recording the total wear time (in hours) of the device during the study period	2 weeks

Collaborators and Investigators

• Sponsor: Joanne Outtrim
• Collaborators: University of Cambridge
• Investigators: Principal Investigator: Ari Ercole, Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• Grimes L, Outtrim JG, Griffin SJ, Ercole A. Accelerometery as a measure of modifiable physical activity in high-risk elderly preoperative patients: a prospective observational pilot study. BMJ Open. 2019 Nov 3;9(11):e032346. doi: 10.1136/bmjopen-2019-032346.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Accelerometer; Frail elderly; Preoperative assessment
• Other Study ID Numbers: A094782; 238840 (Other Identifier: IRAS Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No