NCT03439059

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 4, 2024

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

February 9, 2018

Last Update Submit

February 29, 2024

Conditions

Keywords

Older adultsSedentary behaviourAssisted livingcognitive function

Outcome Measures

Primary Outcomes (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

    10 weeks

Secondary Outcomes (2)

  • Short Form 36 Health Survey

    10 weeks

  • Timed Up and Go test

    10 weeks

Study Arms (2)

intervention- reducing SB

EXPERIMENTAL

prompted to do 10min of light physical activity 3x/day

Behavioral: Reducing Sedentary Behaviour Group

Control

NO INTERVENTION

go about their normal daily living

Interventions

Participants will be prompted to perform 10min of light physical activity (\>1.5 METS) 3x/day for 6 weeks

intervention- reducing SB

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6G 1G9, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Harry Prapavessis, Ph.D

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 20, 2018

Study Start

June 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 4, 2024

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations