Mild Cognitive Impairment Clinical Trial
Official title:
Sedentary Behaviour and Cognitive Function in Community Dwelling Older People: A Feasibility Study
Verified date | February 2022 |
Source | Anglia Ruskin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | October 1, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Queen Elizabeth Hospital NHS Foundation Trust | King's Lynn |
Lead Sponsor | Collaborator |
---|---|
Anglia Ruskin University | Cambridgeshire and Peterborough NHS Foundation Trust |
United Kingdom,
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.20
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Recruitment rate | Proportion of target recruit sample achieved throughout study duration. | Week 13 | |
Primary | Completeness of intervention | Proportion of participants recruited into the study who completed the intervention. | Week 13 | |
Primary | Adverse event rate | Proportion of people recruited into the study who sustained adverse events. | Week 13 | |
Secondary | Device measured sedentary behaviour | Sedentary behaviour and physical activity time per day will be recorded using ActivPAL inclinometer.All participants will be required to wear the ActivPAL continuously for at least 7 days at baseline that will measure habitual sedentary behaviour and walking activity each day (Edwardson et al., 2017). The inclinometer will record how many minutes per day each participant is sedentary and engages in light, moderate and vigorous physical activities. A recording is made of each 60-second period (called an 'epoch'), and this is classified as being sedentary or light, moderate or vigorous physical activity. The researcher will collect data on the total minutes of sedentary behaviour per day, number of disruptions in sedentary behaviour and total time spent in physical activity (minutes per day in light, moderate and vigorous activity). | Week 1 and 13 | |
Secondary | Self reported sedentary behaviour assessed using the Sedentary Behaviour Questionnaire | Participants will complete a survey questionnaire about weekly time spent participating in selected sedentary behaviours such as watching television and sitting (Rosenberg et al., 2010). The options for respondents include 'None', <=15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6+ hours. | Week 1 and 13 | |
Secondary | Verbal fluency assessed using the Controlled and Oral Word Association Test (COWAT) | The researcher will test participant's verbal fluency (cognitive function) using the Controlled and Oral Word Association Test. The scores represent the number of correct words provided in 60 seconds. Higher scores represent better verbal fluency ability and vice versa. | Week 1 and 13 | |
Secondary | Perceived quality of life using the EuroQol five-dimension questionnaire (EQ-5D) | The participants will self- rate their health using five dimensions provided (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and five response levels: no problems, slight, moderate, severe, unable to/extreme problems. The EQ- Visual Analogue Scale(VAS) records the respondent's overall current health (0-100). Higher VAS scores represent best perceived health and vice versa. | Week 1 and 13 | |
Secondary | Pre-morbid intelligence | This will be evaluated using the National Adult Reading Test. Participants will be asked to read form a list of 50 words and they will be scored based on whether or not they pronounce each word correctly. | Week 1 and 13 |
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