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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03417635
Other study ID # 110598
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2019
Est. completion date August 31, 2019

Study information

Verified date December 2023
Source Western University, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The current study aims to investigate the impact of meditation strategies on measures of attention and electrical signals in the brain in older adults. Investigators will recruit older adults who are living in the community. Participants will be assigned to one of two groups: 1) guided focused attention group, or 2) music group (control group). All participants will complete three in-person sessions per week and then be encouraged to practice independently on the other days in the week, for a total of four weeks.The current study focuses on focused attention meditation strategies, as it is recommended for beginner-level meditators. This will include training to be able to focus on one's breathing for 20 minute sessions. Focused attention meditation has been found to increase levels of executive functioning and attention. Participants will complete mobility and cognitive assessments at both the beginning and end of the intervention. These will be completed in the retirement homes for convenience. Participants will also attend an in-lab session to complete electroencephalogram (EEG) testing at both timepoints.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. minimum 60 years of age, 2. minimum completed high school, 3. must be comfortable writing and reading English, 4. be able to walk independently, 5. must be right-handed (for EEG analysis), 6. score 6+/8 on the instrumental activities of daily living scale, 7. score >24/30 on the Mini-Mental Status examination. Exclusion Criteria: To be included, participants must NOT: 1. have a diagnosis of neurodegenerative disease, 2. have a diagnosis of cognitive impairment (e.g., MCI), 3. have a diagnosis of a psychiatric condition, 4. have had a concussion in the last 12 months, 5. have had a stroke, 6. have musculoskeletal or joint disease, 7. experience dizziness or loss of balance, 8. have visual, auditory, or somatosensory impairment, or 9. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Guided focused attention
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.
Acoustic music
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.

Locations

Country Name City State
Canada Community London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Change in sustained attention Measured by performance on sustained attention task. 4 weeks
Secondary Change in global attention Measured by electrophysiological measures of attention. 4 weeks
Secondary Change in mobility Measured by the Timed Up and Go test. 4 weeks
Secondary Change in mobility and balance Measured by the Short Physical Performance Battery. 4 weeks
Secondary Change in memory Measured with the Rey Auditory Verbal Learning Test 4 weeks
Secondary Change in conflict resolution Measured with the stroop task 4 weeks
Secondary Change in set-shifting Measured with the trail making task 4 weeks
Secondary Change in working memory Measured with the digit span task 4 weeks
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