Understanding Pre-operative Activity Levels in Elderly Patients

NCT03737903 | Unknown

• 2 other identifiers: A094782238840
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Physical Activity; Aging

Keywords

Frail elderly; Accelerometer; Preoperative assessment

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (5)

• 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).

  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.

  2 weeks

• Correlation between objectively measured physical activity and patient reported physical activity

  2 weeks

• Subjective measurement of baseline physical activity levels using validated self-reported physical activity questionnaire, across different surgical specialties.

  2 weeks

• Determine participant compliance in wearing the accelerometer device

  2 weeks

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Participant refusal
• PRIME clinic appointment scheduled less than 72hrs after the nurse led pre-assessment clinic

Sponsors & Collaborators

• Joanne Outtrim: lead
• University of Cambridge: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambs, CB20QQ, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 31685513 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ari Ercole

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Grimes

CONTACT

01223 274446; lag31@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Nurse

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: November 13, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)