Cognitive ImpairmentRESEDENTNCT03439059
REducing SEDENTary Behaviour May Slow Cognitive Decline in Older Adults With Mild Cognitive Impairment: A Pilot Study
A study testing Reducing Sedentary Behaviour Group in people with Cognitive Impairment and Physical Functioning, run by Western University, Canada at 1 site in Canada.
Trial summary
With the nation's fastest growing demographic being adults over 65, one in every three seniors is estimated to die from Alzheimer's Disease (AD). The strong correlation between AD and age, combined with the exponential growth of this demographic, highlights the need for non-pharmaceutical treatment/prevention… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Cognitive Impairment, Physical Functioning, Quality of Life
- What is being tested?
- Reducing Sedentary Behaviour Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Inclusions:
- aged 65+ years old
- residing in the ALF permanently
- able to read, write and understand English
- answer "yes" to "do you have difficulty with your memory"
- get consent from their physician to participate in the study
- diagnosed with mild- moderate cognitive impairment by obtaining a score of 14-29, inclusive, on the Mini Mental State Examination (Folstein, Folstein, \& McHugh, 1975).
Exclusions:
- any physical condition or disability disallowing participation in PA
- apparent evidence of any neurodegenerative disorders other than Alzheimer's disease
- score of 6 or higher on the Geriatric Depression Scale (Almeida, 1999), due to the apparent presence of clinically significant depressive symptoms and finally
Trial locations and contacts
1 site in 1 country.
About this study
With the nation's fastest growing demographic being adults over 65, one in every three seniors is estimated to die from Alzheimer's Disease (AD). The strong correlation between AD and age, combined with the exponential growth of this demographic, highlights the need for non-pharmaceutical treatment/prevention strategies. Research has established a relationship between moderate to vigorous physical activity (PA) and improved cognitive functioning. However, there is insufficient evidence to support this relationship at the lower end of the PA spectrum. Assisted living facilities (ALF) are an easy target for reducing SB, as many individuals in these facilities have various functional limitations and therefore cannot meet the recommended PA guidelines. Older adults are also the most sedentary population, with results showing over 8.5+ hours daily spent in SB. ALF typically provide meals, laundry services as well as housekeeping duties, leaving the residents very susceptible to large amounts of SB. The primary purpose of my study is investigating how reducing sedentary behaviour (SB) in ALF will affect Alzheimer's Disease Assessment Scale-cognitive scores among older adults aged 65 and older with mild-to-moderate cognitive impairment. I will also investigate its effects on physical functioning with the Timed Up and Go test (TUG) and quality of life with the Short Form 36 (SF-36) Health Survey. Participants will be prompted to take a 10-minute light intensity PA break at three different time points throughout the day, reallocating SB to any task equating to over 1.5 metabolic equivalents. Positive findings may encourage ALF to implement policies and procedures regarding SB.
Read the detailed description
Dementia is the leading cause of dependence and disability worldwide. With the nation's fastest growing demographic being adults over 65, the Lewy Body Dementia Association states that the current cost puts it higher than either heart disease or cancer; as the financial burden was estimated at $818 billion in 2015. Functional limitations such as a slower gait, muscle weakness (ex. grip strength), unintentional weight loss and self-reported exhaustion adds pressure on healthcare services. Older adults transitioning into assisted living facilities (ALF) will need assistance with activities of daily living; as this population is the most sedentary. Although exercise interventions show positive effects for the management of chronic diseases, as well as cognition and physical functioning, the Canadian Health Measures Survey reported that only 13% of older adults 60- 79 years old were meeting the physical activity (PA) guidelines set out by the World Health Organization. That said, research has yet to establish what benefits may come from the lower end of the PA spectrum; and there are no current guidelines for how long older adults should be sedentary. Research shows that large amounts of sedentary behaviour (SB) leads to an increased risk of all-cause mortality, independent from not meeting the PA guidelines (Ekelund et al., 2016). SB is defined as any waking behaviour characterized by an energy expenditure less than or equal to 1.5 metabolic equivalents while in a sitting or reclining posture. Alzheimer's Disease (AD) is the most common form of Dementia, accounting for 60-80% of cases; and Mild Cognitive Impairment (MCI) is generally used to refer to the transitional zone between normal cognitive functioning and clinically probable AD. With no current cure for AD, the need for effective non-pharmaceutical treatments are imperative.
The purpose of my study will be to investigate the effect of reducing SB on Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) scores among older adults aged 65 years and older with moderate cognitive impairment. Also, examine their changes in physical functioning and their quality of life. I hypothesize that the decline in ADAS-cog scores will be slower and physical scores as well as quality of life (QoL) scores will improve in the intervention group vs controls.
A clustered randomized control pilot study; involving an ALF in London, Ontario will be conducted. The intervention group will be prompted to take a 10-minute light intensity PA break three times throughout the day. The PA will be any task equating to over 1.5 metabolic equivalents and will be recorded in a simplified diary. Eligible subjects will undergo the following tests at baseline: 1) the Mini Mental State Examination and 2) the Community Healthy Activities Program for Seniors survey, 3) Timed Up and Go test (TUG) for physical functioning; 4) ADAS-cog for cognitive functioning; and 5) the Short Form- 36 Health Survey to assess QoL. Both groups will wear an activity tracker during a baseline period before the intervention to collect baseline levels of physical activity. Both groups will also be required to wear the activity monitor for a period during the intervention to check adherence. Following the intervention, the CHAMPS questionnaire will be re-administered along with the ADAS-cog, TUG and SF-36.
Research at the bottom end of the PA spectrum is crucial, as residents in ALF have various functional limitations; and many cannot meet the current PA guidelines. If improvements are shown from my study, this could contribute to the design of a policy that can be implemented into all ALF; lessening the burden on the health care system and loved ones.
- Conditions
- Cognitive Impairment, Physical Functioning, Quality of Life
- Being tested
- Reducing Sedentary Behaviour Group
- Keywords
- Older adults, Sedentary behaviour, Assisted living, cognitive function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Sedentary Behaviour GroupBehavioural
Participants will be prompted to perform 10min of light physical activity (>1.5 METS) 3x/day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| intervention- reducing SB | Experimental | prompted to do 10min of light physical activity 3x/day Receives: Behavioral: Reducing Sedentary Behaviour Group |
| Control | No intervention | go about their normal daily living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimers Disease Assessment Scale- Cognitive (ADAS-cog)
The ADAS-Cog Sub-Scale is the standard cognitive outcome measure used in clinical trials for patients with mild to moderate Alzheimer's disease. The test consists of 11 brief cognitive tests assessing memory, language, praxis, attention and other cognitive abilities. Scores range from 0 to 70, with higher scores indicating greater severity of cognitive impairment
Measured: 10 weeks
Secondary outcomes (2)
Short Form 36 Health Survey
Used for measuring functional health status and wellbeing in older adults. The questionnaire consists of 36 questions and is designed to measure eight multi-item dimensions, covering functional status, well being and overall evaluation of health.
Measured: 10 weeks
Timed Up and Go test
A test for measuring basic functional mobility. It consists of the time taken (in seconds) to stand up from a standard arm chair, walk 3 m, turn around, and walk back to the chair and sit down again
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harry Prapavessis, Western University, Canada
- Investigators
- Harry Prapavessis, Ph.D, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439059
- Sponsor's protocol ID
- RESEDENT study
- Acronym
- RESEDENT
- Status last verified
- Jan 2019
- First submitted
- 9 Feb 2018
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REducing SEDENTary Behaviour May Slow Cognitive Decline in Older Adults With Mild Cognitive Impairment: A Pilot Study
- ClinicalTrials.gov ID
- NCT03439059
- Acronym / sponsor ID
- RESEDENT / RESEDENT study
- Conditions
- Cognitive Impairment, Physical Functioning, Quality of Life
- Keywords
- Older adults, Sedentary behaviour, Assisted living, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the nation's fastest growing demographic being adults over 65, one in every three seniors is estimated to die from Alzheimer's Disease (AD). The strong correlation between AD and age, combined with the exponential growth of this demographic, highlights the need for non-pharmaceutical treatment/prevention strategies. Research has established a relationship between moderate to vigorous physical activity (PA) and improved cognitive functioning. However, there is insufficient evidence to support this relationship at the lower end of the PA spectrum. Assisted living facilities (ALF) are an easy target for reducing SB, as many individuals in these facilities have various functional limitations and therefore cannot meet the recommended PA guidelines. Older adults are also the most sedentary population, with results showing over 8.5+ hours daily spent in SB. ALF typically provide meals, laundry services as well as housekeeping duties, leaving the residents very susceptible to large amounts of SB. The primary purpose of my study is investigating how reducing sedentary behaviour (SB) in ALF will affect Alzheimer's Disease Assessment Scale-cognitive scores among older adults aged 65 and older with mild-to-moderate cognitive impairment. I will also investigate its effects on physical functioning with the Timed Up and Go test (TUG) and quality of life with the Short Form 36 (SF-36) Health Survey. Participants will be prompted to take a 10-minute light intensity PA break at three different time points throughout the day, reallocating SB to any task equating to over 1.5 metabolic equivalents. Positive findings may encourage ALF to implement policies and procedures regarding SB.
Detailed description
Dementia is the leading cause of dependence and disability worldwide. With the nation's fastest growing demographic being adults over 65, the Lewy Body Dementia Association states that the current cost puts it higher than either heart disease or cancer; as the financial burden was estimated at $818 billion in 2015. Functional limitations such as a slower gait, muscle weakness (ex. grip strength), unintentional weight loss and self-reported exhaustion adds pressure on healthcare services. Older adults transitioning into assisted living facilities (ALF) will need assistance with activities of daily living; as this population is the most sedentary. Although exercise interventions show positive effects for the management of chronic diseases, as well as cognition and physical functioning, the Canadian Health Measures Survey reported that only 13% of older adults 60- 79 years old were meeting the physical activity (PA) guidelines set out by the World Health Organization. That said, research has yet to establish what benefits may come from the lower end of the PA spectrum; and there are no current guidelines for how long older adults should be sedentary. Research shows that large amounts of sedentary behaviour (SB) leads to an increased risk of all-cause mortality, independent from not meeting the PA guidelines (Ekelund et al., 2016). SB is defined as any waking behaviour characterized by an energy expenditure less than or equal to 1.5 metabolic equivalents while in a sitting or reclining posture. Alzheimer's Disease (AD) is the most common form of Dementia, accounting for 60-80% of cases; and Mild Cognitive Impairment (MCI) is generally used to refer to the transitional zone between normal cognitive functioning and clinically probable AD. With no current cure for AD, the need for effective non-pharmaceutical treatments are imperative.
The purpose of my study will be to investigate the effect of reducing SB on Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) scores among older adults aged 65 years and older with moderate cognitive impairment. Also, examine their changes in physical functioning and their quality of life. I hypothesize that the decline in ADAS-cog scores will be slower and physical scores as well as quality of life (QoL) scores will improve in the intervention group vs controls.
A clustered randomized control pilot study; involving an ALF in London, Ontario will be conducted. The intervention group will be prompted to take a 10-minute light intensity PA break three times throughout the day. The PA will be any task equating to over 1.5 metabolic equivalents and will be recorded in a simplified diary. Eligible subjects will undergo the following tests at baseline: 1) the Mini Mental State Examination and 2) the Community Healthy Activities Program for Seniors survey, 3) Timed Up and Go test (TUG) for physical functioning; 4) ADAS-cog for cognitive functioning; and 5) the Short Form- 36 Health Survey to assess QoL. Both groups will wear an activity tracker during a baseline period before the intervention to collect baseline levels of physical activity. Both groups will also be required to wear the activity monitor for a period during the intervention to check adherence. Following the intervention, the CHAMPS questionnaire will be re-administered along with the ADAS-cog, TUG and SF-36.
Research at the bottom end of the PA spectrum is crucial, as residents in ALF have various functional limitations; and many cannot meet the current PA guidelines. If improvements are shown from my study, this could contribute to the design of a policy that can be implemented into all ALF; lessening the burden on the health care system and loved ones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention- reducing SB | Experimental | Behavioral: Reducing Sedentary Behaviour Groupprompted to do 10min of light physical activity 3x/day |
| Control | No intervention | –go about their normal daily living |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducing Sedentary Behaviour GroupParticipants will be prompted to perform 10min of light physical activity (>1.5 METS) 3x/day for 6 weeks | Behavioural | intervention- reducing SB |
Primary outcome
Alzheimers Disease Assessment Scale- Cognitive (ADAS-cog)
Time frame: 10 weeks
The ADAS-Cog Sub-Scale is the standard cognitive outcome measure used in clinical trials for patients with mild to moderate Alzheimer's disease. The test consists of 11 brief cognitive tests assessing memory, language, praxis, attention and other cognitive abilities. Scores range from 0 to 70, with higher scores indicating greater severity of cognitive impairment
2 secondary outcomes
Short Form 36 Health Survey
Time frame: 10 weeks
Timed Up and Go test
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Prapavessis, Ph.D principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing Sedentary Behaviour Group in people with Cognitive Impairment and Physical Functioning, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimers Disease Assessment Scale- Cognitive (ADAS-cog) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.