AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
Reducing Sedentary Behaviour Group
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.

Canada1 site
  • Western University

    London, Ontario, N6G 1G9

Other trials in Canada

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.

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 groups in NCT03439059
Study groupRoleWhat they receive
intervention- reducing SBExperimentalprompted to do 10min of light physical activity 3x/day
Receives: Behavioral: Reducing Sedentary Behaviour Group
ControlNo interventiongo about their normal daily living

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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.

  1. First posted20 Feb 2018
  2. Study start1 Jun 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
RESEDENT Clinical Trial NCT03439059 | AzTrials