Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03439059 |
| Other study ID # |
RESEDENT study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
December 31, 2018 |
Study information
| Verified date |
January 2019 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
