REducing SEDENTary Behaviour May Slow Cognitive Decline in Older Adults With Mild Cognitive Impairment: A Pilot Study (RESEDENT)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cognitive Impairment; Physical Functioning
• Intervention / Treatment: Behavioral: Reducing Sedentary Behaviour Group

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 1G9
      • Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention- reducing SB; prompted to do 10min of light physical activity 3x/day	Behavioral: Reducing Sedentary Behaviour Group; Participants will be prompted to perform 10min of light physical activity (>1.5 METS) 3x/day for 6 weeks
No Intervention: Control; go about their normal daily living

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	10 weeks

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Principal Investigator: Harry Prapavessis, Ph.D, Western University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: cognitive function; Older adults; Sedentary behaviour; Assisted living
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: RESEDENT study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No