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Meditation Strategies, Attention, and Mobility in Older Adults

Primary Purpose

Mobility Limitation

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Guided focused attention
Acoustic music
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mobility Limitation focused on measuring Meditation, Cognitive assessment, Executive function, Older adults, Randomized control trial, Mobility

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CommunityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided focused attention

Acoustic music

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change in sustained attention
Measured by performance on sustained attention task.

Secondary Outcome Measures

Change in global attention
Measured by electrophysiological measures of attention.
Change in mobility
Measured by the Timed Up and Go test.
Change in mobility and balance
Measured by the Short Physical Performance Battery.
Change in memory
Measured with the Rey Auditory Verbal Learning Test
Change in conflict resolution
Measured with the stroop task
Change in set-shifting
Measured with the trail making task
Change in working memory
Measured with the digit span task

Full Information

First Posted
January 12, 2018
Last Updated
December 25, 2018
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03417635
Brief Title
Meditation Strategies, Attention, and Mobility in Older Adults
Official Title
Meditation Strategies, Attention, and Mobility in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
Meditation, Cognitive assessment, Executive function, Older adults, Randomized control trial, Mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guided focused attention
Arm Type
Experimental
Arm Description
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.
Arm Title
Acoustic music
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Guided focused attention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acoustic music
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in sustained attention
Description
Measured by performance on sustained attention task.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in global attention
Description
Measured by electrophysiological measures of attention.
Time Frame
4 weeks
Title
Change in mobility
Description
Measured by the Timed Up and Go test.
Time Frame
4 weeks
Title
Change in mobility and balance
Description
Measured by the Short Physical Performance Battery.
Time Frame
4 weeks
Title
Change in memory
Description
Measured with the Rey Auditory Verbal Learning Test
Time Frame
4 weeks
Title
Change in conflict resolution
Description
Measured with the stroop task
Time Frame
4 weeks
Title
Change in set-shifting
Description
Measured with the trail making task
Time Frame
4 weeks
Title
Change in working memory
Description
Measured with the digit span task
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay S Nagamatsu, PhD
Phone
519-661-2111
Ext
88284
Email
lnagamat@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay S Nagamatsu, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay S Nagamatsu, PhD
Phone
519-661-2111
Ext
88284
Email
lnagamat@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19420939
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.
Results Reference
background
PubMed Identifier
19501605
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.
Results Reference
background
PubMed Identifier
24436970
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.
Results Reference
background
Citation
Wallace, B. A. (2006). The attention revolution: Unlocking the power of the focused mind. Somerville, Massachusetts: Wisdom Publications, Inc.
Results Reference
background
PubMed Identifier
24135553
Citation
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.
Results Reference
background
PubMed Identifier
27710818
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.
Results Reference
background
PubMed Identifier
30788136
Citation
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.
Results Reference
derived

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Meditation Strategies, Attention, and Mobility in Older Adults

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