Understanding Pre-operative Activity Levels in Elderly Patients

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

Tracking Information

• First Submitted Date: May 8, 2018
• First Posted Date: November 13, 2018
• Last Update Posted Date: November 13, 2018
• Actual Study Start Date: July 1, 2018
• Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 8, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 8, 2018)

• 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).
• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Understanding Pre-operative Activity Levels in Elderly Patients
• Official Title: Preoperative Use of Wrist-worn Accelerometers to Measure Physical Activity in High-risk Elderly Patients

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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).

Condition

• Surgery
• Physical Activity
• Aging

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 8, 2018): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2019
• Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03737903
• Other Study ID Numbers: A094782; 238840 ( Other Identifier: IRAS Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Joanne Outtrim, Cambridge University Hospitals NHS Foundation Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Joanne Outtrim
• Original Study Sponsor: Same as current
• Collaborators: University of Cambridge

Investigators

• Principal Investigator: Ari Ercole; Cambridge University Hospitals NHS Foundation Trust

• PRS Account: Cambridge University Hospitals NHS Foundation Trust
• Verification Date: November 2018