NCT02926157

Brief Summary

The purpose of this study is to investigate whether a comprehensive group education combined with a lifestyle "activation" program that includes (a) sleep hygiene course, (b) physical activity promotion, and (c) bright light therapy, can improve both sleep quality and cognitive function among 96 community-dwelling older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration 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

September 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

September 21, 2016

Last Update Submit

May 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in sleep quality as measured by Motion Watch 8 at 3 and 6 months

    Baseline, 3 months, and 6 months

Secondary Outcomes (4)

  • Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 3 and 6 months

    Baseline, 3 months, and 6 months

  • Change from baseline in self-reported sleep quality as measured by the Pittsburgh Sleep Quality Index at 3 and 6 months

    Baseline, 3 months, and 6 months

  • Change from baseline in physical activity levels as measured by Motion Watch 8 at 3 and 6 months

    Baseline, 3 months, and 6 months

  • Change from baseline in self-reported physical activity levels as measured by CHAMPS physical activity questionnaire each month

    Monthly, from baseline through 6 months

Study Arms (2)

Life Style and Sleep Group

EXPERIMENTAL

Participants randomized into this group will undergo a 4 week sleep hygiene course (classes 1x/week for 1.5 hours), followed by a 20 week lifestyle activation program. During the 20 week lifestyle activation program, participants wear a Fit Bit and receive a call from a fitness professional every other week for motivation and recommendations, and receive a bright light therapy program from a sleep expert based on their initial sleep results at the baseline measurement session.

Behavioral: Life Style and Sleep Intervention

Wait-list Control

NO INTERVENTION

Participants randomized into this group will complete all measurement sessions. After completion of the final measurement session (6 months), participants will be offered an abbreviated version of the Life Style and Sleep Group intervention including the sleep hygiene course, consultation with sleep expert to go over individual sleep patterns and be given recommendations, along with physical activity recommendations from a fitness expert.

Interventions

Life Style and Sleep Group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Sleep complaints
  • Community-dwelling (not in a long term care facility)
  • Read, write, and speak English
  • Able to walk independently
  • In sufficient health to participate in regular physical activity

You may not qualify if:

  • Diagnosis of obstructive sleep apnea
  • Receiving continuous positive air pressure (CPAP) treatment
  • Diagnosed with dementia of any type
  • At high risk for cardiac complications during physical activity or unable to self-regulate activity or understand recommended activity level
  • Have a clinically important peripheral neuropathy or sever musculoskeletal or joint disease that impairs mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (3)

  • Balbim GM, Boa Sorte Silva NC, Falck RS, Kramer AF, Voss MW, Liu-Ambrose T. 24-hour activity cycle behaviors and gray matter volume in mild cognitive impairment. Alzheimers Dement. 2025 Jul;21(7):e70496. doi: 10.1002/alz.70496.

  • Falck RS, Davis JC, Best JR, Chan PCY, Li LC, Wyrough AB, Bennett KJ, Backhouse D, Liu-Ambrose T. Effect of a Multimodal Lifestyle Intervention on Sleep and Cognitive Function in Older Adults with Probable Mild Cognitive Impairment and Poor Sleep: A Randomized Clinical Trial. J Alzheimers Dis. 2020;76(1):179-193. doi: 10.3233/JAD-200383.

  • Falck RS, Davis JC, Best JR, Li LC, Chan PCY, Wyrough AB, Landry GJ, Liu-Ambrose T. Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment. Trials. 2018 Aug 17;19(1):445. doi: 10.1186/s13063-018-2837-7.

Study Officials

  • Teresa Liu-Ambrose, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Glenn Landry, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Linda Li, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Catherine Chan, MPT

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • John Best, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Cindy Barha, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Jennifer Davis, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2016

First Posted

October 6, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations