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Meditation Strategies, Attention, and Mobility in Older Adults

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ClinicalTrials.gov Identifier: NCT03417635
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Lindsay Nagamatsu, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Behavioral: Guided focused attention Behavioral: Acoustic music Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Meditation Strategies, Attention, and Mobility in Older Adults
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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.

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.

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.

Behavioral: 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.




Primary Outcome Measures :
  1. Change in sustained attention [ Time Frame: 4 weeks ]
    Measured by performance on sustained attention task.


Secondary Outcome Measures :
  1. Change in global attention [ Time Frame: 4 weeks ]
    Measured by electrophysiological measures of attention.

  2. Change in mobility [ Time Frame: 4 weeks ]
    Measured by the Timed Up and Go test.

  3. Change in mobility and balance [ Time Frame: 4 weeks ]
    Measured by the Short Physical Performance Battery.

  4. Change in memory [ Time Frame: 4 weeks ]
    Measured with the Rey Auditory Verbal Learning Test

  5. Change in conflict resolution [ Time Frame: 4 weeks ]
    Measured with the stroop task

  6. Change in set-shifting [ Time Frame: 4 weeks ]
    Measured with the trail making task

  7. Change in working memory [ Time Frame: 4 weeks ]
    Measured with the digit span task



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417635


Contacts
Contact: Lindsay S Nagamatsu, PhD 519-661-2111 ext 88284 lnagamat@uwo.ca

Locations
Canada, Ontario
Community Recruiting
London, Ontario, Canada
Contact: Lindsay S Nagamatsu, PhD    519-661-2111 ext 88284    lnagamat@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
Principal Investigator: Lindsay S Nagamatsu, PhD Western University

Publications:
Responsible Party: Lindsay Nagamatsu, Assistant Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03417635     History of Changes
Other Study ID Numbers: 110598
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lindsay Nagamatsu, Western University, Canada:
Meditation
Cognitive assessment
Executive function
Older adults
Randomized control trial
Mobility

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms