NCT03417635

Brief Summary

Approximately 30% of community-dwelling older adults experience one or more falls per year, resulting in injuries, loss of independence, and reduced quality of life. While there are known physiological risk factors for falls, including poor balance and altered gait patterns, it is now recognized that impaired cognitive functioning is also a risk factor for falls. Within the broad construct of cognition, one specific domain that has been focused on in the falls literature is attention. The literature suggests that improving attention in those at-risk for falls may reduce older adult's risk of falling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 12, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

January 12, 2018

Last Update Submit

December 4, 2023

Conditions

Keywords

MeditationCognitive assessmentExecutive functionOlder adultsRandomized control trialMobility

Outcome Measures

Primary Outcomes (1)

  • Change in sustained attention

    Measured by performance on sustained attention task.

    4 weeks

Secondary Outcomes (7)

  • Change in global attention

    4 weeks

  • Change in mobility

    4 weeks

  • Change in mobility and balance

    4 weeks

  • Change in memory

    4 weeks

  • Change in conflict resolution

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Guided focused attention

EXPERIMENTAL

Participants will take part in a guided focused attention practice led by the researcher. This will include strategies used in meditations where participants focus on their breathing. More specifically, they will be instructed to close their eyes and focus on the sensation of breathing in one area of the body for the entire session. They will be given reminders throughout the session to remain on task (focusing on the breath) and not to let their thoughts wander. Participants will be asked to either sit on a chair or cushion on floor to ensure they are comfortable to sit still for the session, but not so much that they might fall asleep.

Behavioral: Guided focused attention

Acoustic music

ACTIVE COMPARATOR

Participants will be instructed to listen to a prepared soothing acoustic music track. The sessions will be led by a researcher. Participants will be asked to close their eyes and relax while listening to the music. Participants will be asked to sit on a chair or cushion on floor to ensure they are comfortable to sit still for the session, but not so much they might fall asleep This group is used as active control group to control for socialization in group settings and any effects of consciously relaxing for the meetings.

Behavioral: Acoustic music

Interventions

Participants will meet for 20 minute group sessions with 6-10 participants in each group. There will be three meetings a week for a four week period. The focused attention practice itself will last for 20 minutes with instructions being given during the 20 minute period. All sessions will occur in the retirement home in a community room to ensure the sessions are easily accessible to the participants.

Guided focused attention
Acoustic musicBEHAVIORAL

Participants will meet for 20 minute group sessions with 6-10 participants in each group. There will be three meetings a week for a four week period. The acoustic music track itself will last for 20 minutes with instructions being given during the 20 minute period. All sessions will occur in the retirement home in a community room to ensure the sessions are easily accessible to the participants.

Acoustic music

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • minimum 60 years of age,
  • minimum completed high school,
  • must be comfortable writing and reading English,
  • be able to walk independently,
  • must be right-handed (for EEG analysis),
  • score 6+/8 on the instrumental activities of daily living scale,
  • score \>24/30 on the Mini-Mental Status examination.

You may not qualify if:

  • To be included, participants must NOT:
  • have a diagnosis of neurodegenerative disease,
  • have a diagnosis of cognitive impairment (e.g., MCI),
  • have a diagnosis of a psychiatric condition,
  • have had a concussion in the last 12 months,
  • have had a stroke,
  • have musculoskeletal or joint disease,
  • experience dizziness or loss of balance,
  • have visual, auditory, or somatosensory impairment, or
  • a recent history (past 2 years) of regular meditation practice (1 or more times per week) or include a meditation component in their religious practice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community

London, Ontario, Canada

Location

Related Publications (9)

  • Martin K, Thomson R, Blizzard L, Wood A, Garry M, Srikanth V. Visuospatial ability and memory are associated with falls risk in older people: a population-based study. Dement Geriatr Cogn Disord. 2009;27(5):451-7. doi: 10.1159/000216840. Epub 2009 May 7.

    PMID: 19420939BACKGROUND
  • Nagamatsu LS, Liu-Ambrose TY, Carolan P, Handy TC. Are impairments in visual-spatial attention a critical factor for increased falls risk in seniors? An event-related potential study. Neuropsychologia. 2009 Nov;47(13):2749-55. doi: 10.1016/j.neuropsychologia.2009.05.022. Epub 2009 Jun 6.

    PMID: 19501605BACKGROUND
  • Nagamatsu LS, Munkacsy M, Liu-Ambrose T, Handy TC. Altered visual-spatial attention to task-irrelevant information is associated with falls risk in older adults. Neuropsychologia. 2013 Dec;51(14):3025-32. doi: 10.1016/j.neuropsychologia.2013.10.002.

    PMID: 24436970BACKGROUND
  • Wallace, B. A. (2006). The attention revolution: Unlocking the power of the focused mind. Somerville, Massachusetts: Wisdom Publications, Inc.

    BACKGROUND
  • Ainsworth B, Eddershaw R, Meron D, Baldwin DS, Garner M. The effect of focused attention and open monitoring meditation on attention network function in healthy volunteers. Psychiatry Res. 2013 Dec 30;210(3):1226-31. doi: 10.1016/j.psychres.2013.09.002. Epub 2013 Oct 14.

    PMID: 24135553BACKGROUND
  • Tsai MH, Chou WL. Attentional orienting and executive control are affected by different types of meditation practice. Conscious Cogn. 2016 Nov;46:110-126. doi: 10.1016/j.concog.2016.09.020. Epub 2016 Oct 3.

    PMID: 27710818BACKGROUND
  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

  • Ford SD, Nagamatsu LS. Four weeks of meditation training improves sustained attention in community-dwelling older adults: a proof-of-concept randomized controlled trial. Front Aging. 2024 Mar 1;5:1322705. doi: 10.3389/fragi.2024.1322705. eCollection 2024.

  • Nagamatsu LS, Ford SD. Can meditation improve attention in older adults? Study protocol for a 4-week proof-of-concept intervention. Pilot Feasibility Stud. 2019 Feb 11;5:22. doi: 10.1186/s40814-019-0413-x. eCollection 2019.

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lindsay S Nagamatsu, PhD

    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
Assistant Professor

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 31, 2018

Study Start

January 2, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations