RESEDENT: REducing SEDENTary Behaviour in Senior Living Facilities

Sponsor
Western University, Canada (Other)
Overall Status
Completed
CT.gov ID
NCT03439059
Collaborator
(none)
21
1
2
7
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reducing Sedentary Behaviour Group
N/A

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

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
REducing SEDENTary Behaviour in Senior Living Facilities: Examining Its Affect on the Progression of Mild Cognitive Impairment, Quality of Life and Physical Functioning: a Pilot Study.
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Alzheimers Disease Assessment Scale- Cognitive (ADAS-cog) [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

Secondary Outcome Measures

  1. Short Form 36 Health Survey [10 weeks]

    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.

  2. Timed Up and Go test [10 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western University London Ontario Canada N6G 1G9

Sponsors and Collaborators

  • Western University, Canada

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Harry Prapavessis, Principal Investigator, Western University, Canada
ClinicalTrials.gov Identifier:
NCT03439059
Other Study ID Numbers:
  • Sedentary Behaviour in Seniors
First Posted:
Feb 20, 2018
Last Update Posted:
Jan 10, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Harry Prapavessis, Principal Investigator, Western University, Canada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2019