ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindful Meditation for Chronic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02687048
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Teresa Liu-Ambrose, University of British Columbia

Brief Summary:

Falls have significant consequences for older adults, including fracture, disability, and death (1). Risk factors for falls include both impaired physical and cognitive function (1). Thus, older adults with chronic stroke are at significant risk for falls (2).

Exercise is an evidence-based approach for reducing falls risk, even among those who are living with stroke-related impairments (3,4). More recently, mindfulness based meditation is gaining recognition for its positive impact on both physical and cognitive health (6,7). Thus, the investigators hypothesize that combining exercise with mindful meditation may be greater impact on falls risk reduction as compared with exercise alone. To begin exploring our hypothesis, we will conduct a 12-week proof-of-concept study among 20 older adults with chronic stroke (i.e., suffered their first clinical stroke > or = 12 months prior to study entry). Participants will be randomly allocated to either: 1) exercise; or 2) exercise + mindfulness based meditation. Outcomes will include measures of mobility, balance, and cognitive function.

  1. Rubenstein, L.. Falls in older people: epidemiology, risk factors, and strategies for prevention. Age and Ageing 2006; 35-S2: ii37-ii41. doi:10.1093/ageing/afl084
  2. Tyson et al. Balance disability after stroke. Physical Therapy January 2006: 86 (1):30-38
  3. Thomas S, et al.Does the 'Otago Exercise Programme' Reduce Mortality and Falls in Older Adults?: A Systematic Review and Meta-analysis. Age Ageing. 2010; 39(6): 681-687.
  4. Verheyden G, et al. Interventions for preventing falls in people after stroke. The Cochrane database of systematic reviews, 2013(5).
  5. Baer R. Mindfulness Training as a Clinical Intervention: A Conceptual and Empirical Review. Clinical Psychology: Science and Practice 2003; 10(2): 125-143.
  6. Grossman P, et al. Mindfulness-based stress reduction and health benefits. A meta-analysis. Journal of Psychosomatic Research, 2004;57(1) 35.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Otago Exercise program Behavioral: Mindful meditation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Mindful Meditation on Mobility, Cognition and Fall Risk in the Older Adult.
Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Active Comparator: EX protocol
Participants will receive a revised version of the Otago exercise program (OEP) - an individualized home-based exercise program; a trained physiotherapist will make 5 home visits throughout the 12-week intervention. The participants will be expected to complete the home exercises as prescribed three times per week. The exercises are for strength and balance and are gradually progressed over the course of the study to meet the individual's abilities.
Behavioral: Otago Exercise program
The Otago exercise program (OEP) is an evidence-based falls prevention home-based program. The participants will be instructed by a physiotherapy to do muscle strengthening and balance exercises (to be done 3x/week). The physiotherapist will progress these exercises during 5 home visits to each participant.
Other Name: OEP

Experimental: EX Plus protocol

These participants will receive mindful meditation coaching via 6 one-hour small group sessions with an experienced meditation instructor. They will also be expected to practice mindful meditation at home following online audio recordings (free of charge from University of California, Los Angeles; http://marc.ucla.edu/body.cfm?id=22) and written instructions a minimum of five times per week for 30 minutes. Participants will complete a meditation log to record their practice.

These participants will also receive the same revised version of the Otago exercise program; a trained physiotherapist will make 5 home visits throughout the 12-week intervention. The participants will be expected to complete the home exercises as prescribed three times per week.

Behavioral: Otago Exercise program
The Otago exercise program (OEP) is an evidence-based falls prevention home-based program. The participants will be instructed by a physiotherapy to do muscle strengthening and balance exercises (to be done 3x/week). The physiotherapist will progress these exercises during 5 home visits to each participant.
Other Name: OEP

Behavioral: Mindful meditation
Mindful meditation aims to reorient the individual to the present and broaden self awareness by promoting attention to internal experiences such as bodily sensations, thoughts, emotions, sights or sounds. The participants will be instructed in mindful meditation during 6 hour-long education sessions and will be expected to practice with audio meditations 30 minutes 5 times per week.
Other Name: meditation




Primary Outcome Measures :
  1. Trail Making Tests (Parts A & B)-change from baseline to 12 weeks [ Time Frame: baseline to 12 weeks. 5 minute test ]
    Participants draw a trail to connect numbers in ascending sequence (part A) and to join alternating numbers and letters in ascending sequence (part B)

  2. Timed Up and Go Test Dual Task-change from baseline to 12 weeks [ Time Frame: baseline to 12 weeks. 5 minute test. ]
    This task assesses the ability of an individual to simultaneously perform the Timed Up and Go Test while performing the cognitive task of serial 7s (i.e., counting backwards from 100 by 7s). Impaired dual-task (specifically of cognitive-mobility pairing) is a key predictor of falls.


Secondary Outcome Measures :
  1. Five Factor Mindfulness Questionnaire-change from baseline to 12 weeks [ Time Frame: baseline to 12 weeks ]
    Self-reported questionnaire on mindfulness traits

  2. Timed Up and Go Test - change from baseline to 12 weeks [ Time Frame: baseline to 12 weeks. 2 minute test. ]
    Participants are instructed to rise from a standard chair, walk a distance of three meters, turn, walk back to the chair and sit down

  3. Stroop Colour-Word Test-change from baseline to 12 weeks [ Time Frame: baseline to 12 weeks. 5 minute test ]
    Participants asked to identify words of colours printing on a page where the colour and word do not match. This is a test for response inhibition.

  4. Verbal digits test (forwards and backwards)-change from baseline to 12 weeks [ Time Frame: baseline to 12 weeks. 10 minute test ]
    Participants are asked to repeat back a string of numbers which increases in length by one digit each time. They then are asked to do the same but reverse the order of the digits (i.e. backwards)

  5. Short Physical Performance Battery-change from baseline to 12 weeks [ Time Frame: baseline to 12 weeks. 15 minute test. ]
    Participants are assessed on performances of standing balance, walking, and sit-to-stand. Each component is rated out of four points, for a maximum of 12 points. Poor performance on this scale predicts subsequent disability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults who had an ischemic or hemorrhagic stroke (confirmed by previous MRI or computed tomography scan).
  • are aged 55 years and over
  • have a history of a single stroke of at least one year prior to study enrollment - have a Mini-Mental State Examination (MMSE) score of 22/30 or greater at screening, including a perfect score on the 3-step command to ensure intact comprehension and ability to follow instructions
  • are community-dwelling
  • live in Greater Vancouver area
  • able to comply with scheduled visits, treatment plan, and other trial procedures
  • read, write, and speak English with acceptable visual and auditory acuity
  • not expected to start or are stable on a fixed dose of cognitive medications (e.g., donepezil, galantamine, etc.) during the study period
  • able to walk for a minimum of six metres with rest intervals with or without assistive devices
  • based on interview, have an activity tolerance of 30 minutes with rest intervals
  • not currently participating in any regular therapy or progressive exercise
  • own an operating computer with internet access and audio
  • provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

  • diagnosed with dementia of any type
  • diagnosed with another type of neurodegenerative or neurological condition (e.g., Parkinson's disease) that affects cognitive function and mobility
  • at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria)
  • have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician
  • taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (i.e., typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.
  • aphasia as judged by an inability to communicate by phone

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): NCT02687048


Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Teresa Liu-Ambrose, Ph.D. UBC Associate Professor

Publications:

Responsible Party: Teresa Liu-Ambrose, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02687048     History of Changes
Other Study ID Numbers: H15-00507
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Teresa Liu-Ambrose, University of British Columbia:
mindful meditation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases