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Cognitive and Lifestyle interventions to Understand the impact on the Elderly of anaesthesia and Surgery (The CLUES trial)

Cognitive and Lifestyle interventions to Understand the impact on the Elderly of anaesthesia and Surgery: A pilot study for an international multi-centre cluster randomized controlled trial. The effect of cognitive and lifestyle interventions on disability free survival at 12 months post surgery.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000513314
Acronym
CLUES
Enrollment
50
Registered
2017-04-07
Start date
2020-01-01
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The present study will utilise the new diagnostic criteria for perioperative cognitive disorders. Together with current best practice guidelines of multidomain interventions to test whether, when offered as a packaged intervention, these interventions reduce the incidence of disability occurring as a result of perioperative cognitive decline in older adults undergoing anaesthesia and surgery. This has the capacity to reduce healthcare costs, delay decline, improve outcomes and reduce the loss of quality-adjusted life years as a result of disability from cognitive impairment. Seven key modifiable risk-factors have been identified (diabetes, hypertension, obesity, smoking, depression, cognitive inactivity and physical inactivity) which account for approximately 50% of all Alzheimer's Disease (AD) and a 10-25% reduction in these could prevent 1.3 million cases of AD worldwide. Several proof-of-concept randomised controlled studies have been undertaken to develop population-level interventions with positive results. Five intervention components have been identified (nutrition, physical exercise, cognitive training, management of vascular and metabolic risk factors and stimulation of social engagement) demonstrating a significant effect on overall cognition. The preoperative education package will include these five intervention components: 1. Physical exercise 2. Cognitive training 3. Nutrition 4. Management of Risk Factors 5. Stimulation of Social Engagement Hypothesis: Preoperative implementation of proven risk reduction interventions for cognitive impairment will reduce the incidence of disability as a result of perioperative cognitive disorders and reduce associated social, healthcare and community costs. The current pilot study will assess feasibility of study design and intervention components prior to undertaking the complete study.

Interventions

The intervention group will receive a preoperative education package about cognitive and lifestyle intervention strategies to reduce the risk of cognitive decline. Participants in this arm of the study will be educated in five components of risk prevention strategies prior to their surgery – exercise, cognitive interventions, nutrition, and modification of health risk factors and stimulation of social engagement. Participants in the intervention group will complete approx. 60 minutes of educati

The intervention group will receive a preoperative education package about cognitive and lifestyle intervention strategies to reduce the risk of cognitive decline. Participants in this arm of the study will be educated in five components of risk prevention strategies prior to their surgery – exercise, cognitive interventions, nutrition, and modification of health risk factors and stimulation of social engagement. Participants in the intervention group will complete approx. 60 minutes of education at enrolment to the study. In this session they will be encouraged to complete 20-30 mins of physical exercise each day, along with spending at least 10 minutes completing some cognitive training each day. This means approx. 30-40 min of activity each day, which may include activities already completed by participant. There is no specific exercise program unless the participant requests, the exercise could involve a 20-30 walk. Nutrition and health risk factors will also be discussed, and possible modification strategies suggested. Current social engagement will also be discussed, with participants encouraged to be engaging in regular social activities each week. This education session will occur at least one month prior to surgery, to allow uptake of strategies. Research Assistants will educate and inform the patient and family at enrolment during a detailed face-to-face interview, and monitor compliance with each component of the intervention by regular phone calls and support for the duration of the trial. Follow up phone calls will be completed following surgery, and 30 days following surgery. These phone calls will take approx. 5 minutes. Participants will also complete neuropsychological testing at enrolment to the study, 3 and 12 months following surgery, each of these follow ups will take approx. 60 mins to complete. Weekly motivational phone calls will be offered to participants during the intervention period - which will vary dependent on participants time on waiting list for their surgery. The intervention period will last from enrolment date until surgery. Participants will complete a questionnaire during the intervention period to determine their degree of uptake for each aspect of the intervention. Education given to participants will be based on the guidelines outlined on the Cognitive Care website http://cognitivecare.gov.au/ Trained research assistants will deliver education sessions at recruitments, and complete neuropsychological testing. This will occur in the participants home, or at the hospital where participant is recruited, depending on participants preference.

Sponsors

St Vincent's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 65yrs and older 2. Sufficient English to complete consent and neuropsychological testing 3. Current referral to a surgeon for further treatment including any elective surgical procedure or diagnostic procedure requiring sedation.

Exclusion criteria

1. Prior neurological deficit (eg Stroke) 2. Contraindication to neuropsychological testing such as language, visual or hearing impairment 3. Patients requiring 3rd party consent for their procedure 4. Patients who will undergo surgery within 1 month of their initial visit (to allow sufficient time for uptake of intervention)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026