Mindful Meditation for Chronic Stroke

NCT02687048 | Completed

• 1 other identifier: H15-00507
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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. 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. 2.Tyson et al. Balance disability after stroke. Physical Therapy January 2006: 86 (1):30-38
3. 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. 4.Verheyden G, et al. Interventions for preventing falls in people after stroke. The Cochrane database of systematic reviews, 2013(5).
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. 6.Grossman P, et al. Mindfulness-based stress reduction and health benefits. A meta-analysis. Journal of Psychosomatic Research, 2004;57(1) 35.

Conditions

Stroke

Keywords

mindful meditation

Outcome Measures

Primary Outcomes (2)

• Trail Making Tests (Parts A & B)-change from baseline to 12 weeks

  Participants draw a trail to connect numbers in ascending sequence (part A) and to join alternating numbers and letters in ascending sequence (part B)

  baseline to 12 weeks. 5 minute test

• Timed Up and Go Test Dual Task-change from baseline to 12 weeks

  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.

  baseline to 12 weeks. 5 minute test.

Secondary Outcomes (5)

• Five Factor Mindfulness Questionnaire-change from baseline to 12 weeks

  baseline to 12 weeks

• Timed Up and Go Test - change from baseline to 12 weeks

  baseline to 12 weeks. 2 minute test.

• Stroop Colour-Word Test-change from baseline to 12 weeks

  baseline to 12 weeks. 5 minute test

• Verbal digits test (forwards and backwards)-change from baseline to 12 weeks

  baseline to 12 weeks. 10 minute test

• Short Physical Performance Battery-change from baseline to 12 weeks

  baseline to 12 weeks. 15 minute test.

Study Arms (2)

EX protocol

ACTIVE COMPARATOR

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

EX Plus protocol

EXPERIMENTAL

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; Behavioral: Mindful meditation

Interventions

Otago Exercise program BEHAVIORAL

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.

Also known as: OEP

EX Plus protocol; EX protocol

Mindful meditation BEHAVIORAL

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.

Also known as: meditation

EX Plus protocol

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

Related Publications (11)

• Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.

  PMID: 16926202 BACKGROUND

• Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006 Jan;86(1):30-8. doi: 10.1093/ptj/86.1.30.

  PMID: 16386060 BACKGROUND

• Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.

  PMID: 20817938 BACKGROUND

• Verheyden GS, Weerdesteyn V, Pickering RM, Kunkel D, Lennon S, Geurts AC, Ashburn A. Interventions for preventing falls in people after stroke. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008728. doi: 10.1002/14651858.CD008728.pub2.

  PMID: 23728680 BACKGROUND

• Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.

  PMID: 15256293 BACKGROUND

• Poulin V, Korner-Bitensky N, Dawson DR, Bherer L. Efficacy of executive function interventions after stroke: a systematic review. Top Stroke Rehabil. 2012 Mar-Apr;19(2):158-71. doi: 10.1310/tsr1902-158.

  PMID: 22436364 BACKGROUND

• Liu-Ambrose T, Eng JJ. Exercise training and recreational activities to promote executive functions in chronic stroke: a proof-of-concept study. J Stroke Cerebrovasc Dis. 2015 Jan;24(1):130-7. doi: 10.1016/j.jstrokecerebrovasdis.2014.08.012. Epub 2014 Oct 18.

  PMID: 25440324 BACKGROUND

• Praissman S. Mindfulness-based stress reduction: a literature review and clinician's guide. J Am Acad Nurse Pract. 2008 Apr;20(4):212-6. doi: 10.1111/j.1745-7599.2008.00306.x.

  PMID: 18387018 BACKGROUND

• Lawrence M, Booth J, Mercer S, Crawford E. A systematic review of the benefits of mindfulness-based interventions following transient ischemic attack and stroke. Int J Stroke. 2013 Aug;8(6):465-74. doi: 10.1111/ijs.12135.

  PMID: 23879751 BACKGROUND

• Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. doi: 10.1136/bmj.315.7115.1065.

  PMID: 9366737 BACKGROUND

• Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

  PMID: 12703651 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Mindfulness; Meditation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy

Study Officials

• Teresa Liu-Ambrose, Ph.D.

  UBC Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)