The Impact of Mindful Meditation on Mobility, Cognition and Fall Risk in the Older Adult.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Timed Up and Go Test Dual Task-change from baseline to 12 weeks
研究概览
简要总结
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.
- 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
- Tyson et al. Balance disability after stroke. Physical Therapy January 2006: 86 (1):30-38
- 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.
- Verheyden G, et al. Interventions for preventing falls in people after stroke. The Cochrane database of systematic reviews, 2013(5).
- Baer R. Mindfulness Training as a Clinical Intervention: A Conceptual and Empirical Review. Clinical Psychology: Science and Practice 2003; 10(2): 125-143.
- Grossman P, et al. Mindfulness-based stress reduction and health benefits. A meta-analysis. Journal of Psychosomatic Research, 2004;57(1) 35.
详细描述
Purpose: The intent of this study is to investigate whether, in stroke survivors, the combination of the Otago exercise program (OEP) and mindfulness based meditation (MBM) may be more efficacious than OEP alone with respect to balance, mobility, and executive functions.
Hypothesis: The investigators hypothesize that the exercise home program combined with MBM will be more efficacious than exercise alone in improving balance, mobility, and executive functions for stroke survivors.
Justification of the Study:
Each year, over 40 000 Canadians experience a stroke and approximately 40% of stroke survivors are left with moderate to severe impairment (1). Balance problems are common for stroke survivors and have been implicated with diminished function in activities of daily living (ADLs) and mobility and associated with an increased risk of falls(2). Stroke survivors have been shown to have greater postural sway and altered weight distribution patterns, especially when moving their weight in the direction of the affected lower extremity(3). These patterns have been seen in static and dynamic balance and at all levels of function(2, 3). Falls are commonly seen after stroke and even less serious falls may lead to stroke survivors developing a fear of falling and limiting activity(4).
Executive function is also commonly negatively affected by stroke. Executive functions refer to high-level cognitive processes including initiation, planning, sequencing, monitoring, solving novel problems, modifying behaviour in light of new information, performing two tasks concurrently, generating strategies, inhibition and working memory(5, 6). Between 19-75% of stroke survivors show impaired executive function skills (6, 7). Persistent deficits in executive function of stroke survivors negatively impact recovery with an elevated risk of functional dependence, failure to return to work, and poor social participation (6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Otago Exercise program (Behavioral)
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.
干预措施: Otago Exercise program (Behavioral)
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.
干预措施: Mindful meditation (Behavioral)
结局指标
主要结局
Timed Up and Go Test Dual Task-change from baseline to 12 weeks
时间窗: 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.
Trail Making Tests (Parts A & B)-change from baseline to 12 weeks
时间窗: 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)
次要结局
- 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)
- Five Factor Mindfulness Questionnaire-change from baseline to 12 weeks(baseline to 12 weeks)
- 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.)
研究者
Teresa Liu-Ambrose
Principal Investigator
University of British Columbia