- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03417635
Meditation Strategies, Attention, and Mobility in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lindsay S Nagamatsu, PhD
- Phone Number: 88284 519-661-2111
- Email: lnagamat@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada
- Community
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guided focused attention
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. |
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.
|
Active Comparator: Acoustic music
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sustained attention
Time Frame: 4 weeks
|
Measured by performance on sustained attention task.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in global attention
Time Frame: 4 weeks
|
Measured by electrophysiological measures of attention.
|
4 weeks
|
Change in mobility
Time Frame: 4 weeks
|
Measured by the Timed Up and Go test.
|
4 weeks
|
Change in mobility and balance
Time Frame: 4 weeks
|
Measured by the Short Physical Performance Battery.
|
4 weeks
|
Change in memory
Time Frame: 4 weeks
|
Measured with the Rey Auditory Verbal Learning Test
|
4 weeks
|
Change in conflict resolution
Time Frame: 4 weeks
|
Measured with the stroop task
|
4 weeks
|
Change in set-shifting
Time Frame: 4 weeks
|
Measured with the trail making task
|
4 weeks
|
Change in working memory
Time Frame: 4 weeks
|
Measured with the digit span task
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lindsay S Nagamatsu, PhD, Western University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Wallace, B. A. (2006). The attention revolution: Unlocking the power of the focused mind. Somerville, Massachusetts: Wisdom Publications, Inc.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110598
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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