Reducing Sedentary Behaviour and Cognition in Older People

NCT04464538 | Completed

• 1 other identifier: IRAS280073
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction Sedentary behaviour refers to activities of low energy expenditure in lying and sitting positions. Examples include driving, watching television, playing cards, puzzles and working on a computer. Studies suggest that between 60% of older people world-wide reported sitting for more than four hours per day. Sedentary behaviour increases as older people become older, have problems with cognition and when they are very ill. Excessive participating in sedentary behaviours is associated with an increased risk of heart problem, cancer death and diabetes. However, we do not know for certain whether or not participating in sedentary behaviour could cause poorer cognition. What does the study hope to achieve? This feasibility study will test whether the main study, which is planned for later, is workable with regards to the following:

• Will reducing sedentary behaviour using our online health coaching intervention (WALC-R) be acceptable to research participants and caregivers?
• How many participants can be successfully recruited to the future trial?
• What is the rate of adverse event associated with proposed study intervention? Method: This is a 13-week randomised feasibility study. We will randomly assign study participants to either the health coaching intervention (WALC-R) or receiving health guidelines on recommended physical activity. We aim to recruit 40 participants aged 50 and over who have been diagnosed with Mild Cognitive Impairment. The future main study will be larger and test whether:
• 'WALC-R', an online intervention designed to reduce participation in sedentary behaviour can improve cognitive function in older people with Mild Cognitive Impairment compared with providing an information sheet about physical activity.

Conditions

Mild Cognitive Impairment

Keywords

Sedentary behaviour; Cognitive function; Feasibility study; Older adults

Outcome Measures

Primary Outcomes (4)

• Acceptability of intervention assessed by semi-structured interviews

  Acceptability of study intervention will be qualitatively assessed at the end of week 13 via semi-structured interviews with study participants.

  Week 13

• Recruitment rate

  Proportion of target recruit sample achieved throughout study duration.

  Week 13

• Completeness of intervention

  Proportion of participants recruited into the study who completed the intervention.

  Week 13

• Adverse event rate

  Proportion of people recruited into the study who sustained adverse events.

  Week 13

Secondary Outcomes (5)

• Device measured sedentary behaviour

  Week 1 and 13

• Self reported sedentary behaviour assessed using the Sedentary Behaviour Questionnaire

  Week 1 and 13

• Verbal fluency assessed using the Controlled and Oral Word Association Test (COWAT)

  Week 1 and 13

• Perceived quality of life using the EuroQol five-dimension questionnaire (EQ-5D)

  Week 1 and 13

• Pre-morbid intelligence

  Week 1 and 13

Study Arms (2)

Health information

PLACEBO COMPARATOR

Participants in the control group will complete baseline measures, and then they will receive written information on the benefits of increasing activity levels. This advice will be given in accordance with NHS guide on physical health.

Other: Information leaflet

Group education session and individualised coaching (online)

EXPERIMENTAL

Participants assigned to the WALC-R intervention will attend a virtual baseline educational group session which will include a maximum of five people. The aim of the sessions will be to introduce the basics of the benefits of walking for exercise and why exercise is beneficial, as well as to give information, support and motivation to help participants to independently walk more in their daily routines.The group session will also include goal setting, in which participants will be encouraged to set their own daily walking targets to increase their habitual levels of walking. All participants will be given a pedometer to self-monitor how far they walk and a diary to record activity context throughout the intervention daily. Participants will meet briefly (20-30 minutes) via the internet with an assigned coach every 2 weeks.

Behavioral: WALC-R

Interventions

WALC-R BEHAVIORAL

Initial group education session and individualized coaching (remote)

Group education session and individualised coaching (online)

Information leaflet OTHER

Participants in the control group will complete baseline measures, and then they will receive written information on the benefits of increasing activity levels. This advice will be given in accordance with NHS guide on physical health.

Health information

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community dwelling adults aged 50+ years.
• Doctor diagnosis of Mild Cognitive Impairment OR MCI diagnosis which meets Petersen Criteria.
• Participants must have a working knowledge of English.
• Participants must be able to provide informed consent.

You may not qualify if:

• Individuals diagnosed by doctor with dementia.
• Individuals diagnosed with severe mental health conditions and substance use disorders e.g. alcohol or drug abuse in within the last year.
• Individuals with diagnosed neurological conditions.

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Cambridgeshire and Peterborough NHS Foundation Trust: collaborator

Study Sites (1)

The Queen Elizabeth Hospital NHS Foundation Trust

Kings Lynn, PE30 4ET, United Kingdom

Location

Related Publications (1)

• Olanrewaju, O. et al. (2022) 'Reducing sedentary behaviour and cognitive function in older people with Mild Cognitive Impairment: Results of a randomized feasibility study', Aging and Health Research, 2(1), p. 100057. doi: https://doi.org/10.1016/j.ahr.2022.100057.

  RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Unblinded, single-centre randomized feasibility study

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: October 20, 2020
• Primary Completion: August 31, 2021
• Study Completion: October 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)