Clinical trial NCT02283541: Gait, Depression, and Mind-body Therapy in Seniors
Official title: Investigating the Relationship Between Gait, Depression, and Mind-body Therapy in Seniors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Gait
late life depression
mind-body therapies
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Falls are the leading cause of injury---related hospitalization and death in the elderly. As such, fear of falling (FOF) is common among senior populations and often leads to activity avoidance, social isolation, and reduced physical and mental health. Risk of falls is particularly concerning for individuals suffering from late life depression (LLD) as both depression and antidepressant treatment have been shown to be linked to gait impairments, a strong predictor of fall risk. Currently, our team is conducting a study to examine the effects of a non---pharmacological mind---body therapy commonly known as automatic self---transcending meditation (ASTM) on autonomic and mood---related symptoms of LLD. This study provides a timely opportunity to explore the intricate relationship between gait disturbances and depression severity, as well as the potential benefits of ASTM intervention on gait and FOF in seniors. Using a GAITRite® portable walkway, measures of stride length and gait velocity will be obtained for seniors in the ASTM and control study arms every four weeks for the duration of the ASTM program. The aim of this study is to answer the following research questions: are gait impairments and depression severity correlated, and does ASTM training have any effect on gait and FOF? The results of this study could not only provide insight into the physical manifestations of depression but if ASTM training is found to improve gait and reduce FOF then there is potential to use this mind---body meditation technique as an adjunct therapy to reduce fall risk in seniors with LLD. Furthermore, future research could expand upon these findings to examine the benefits of ASTM on gait impairments secondary to other psychiatric illnesses.

Detailed description: Falls are the leading cause of injury---related death in senior populations (i.e. 65 years of age and older)

1. ; approximately 30% of community---dwelling seniors suffer a fall at least once per year, with this proportion increasing with age
2. . In Canada, 40% of falls by seniors result in hip fractures which oftentimes leads to only partial recovery
3. , therefore it is not uncommon for older adults to report a fear of falling (FOF). FOF is particularly common in community---dwelling older females and those who have previously experienced a fall \[4,5\]. In some individuals, FOF actually leads to activity avoidance

\[5\]. Moreover, seniors who have suffered a fall report reductions in their quality of life \[6\]. A systematic review by Scheffer et al. \[4\] has identified the major outcomes of FOF to be reductions in physical and mental health, quality of life and an increased risk of fall. Older adults suffering symptoms of depression are also more likely to have a severe FOF, leading to activity restriction in this group \[7, 8\]. As such, minimizing the risk of falls in older populations has important implications for the physical and mental wellbeing of individuals in this cohort. Among the risk factors that increase the likelihood of seniors suffering a fall are gait impairments \[9\] and depression \[10---12\]. Indeed, measures of gait can be used to predict future falls \[13\] while increases in depressive symptoms are associated with increases in fall rate \[10\]. An association has been established between depression and gait deficits, even when confounding variables such as socio---demographic and overall health status are controlled; specifically, depression is associated with reductions in various gait parameters including gait velocity, stride length and swing time variability \[14, 15\]. At present, antidepressants are the first line of treatment for depression, however in seniors the response rate to an antidepressant trial of adequate dose and duration is often inadequate and can be as low as 30--- 40% \[16\]. In addition, antidepressant use is often associated with a number of adverse events including increased fall risk \[11\] and impairments in gait \[17, 18\]. For example, in healthy seniors, a single dose of amitriptyline led to gait impairments when subjects were required to walk in the presence of obstructions \[17\]. Therefore the relationship between depression, gait, and fall risk is further complicated by standard pharmacological treatment practices for this population. In recent years, various non---pharmacological interventions have been embraced by patients with late life depression (LLD). Loosely defined as mind---body therapies, these include biofeedback, energy healing, meditation, guided imagery, and yoga \[19, 20\]. Amongst these practices, meditation therapy may be of particular benefit for older adults with gait impairments and LLD; meditation is non---invasive, easy to learn, has negligible side effects, can be practiced from anywhere and has been shown to have multi---organ benefits \[see 21 for a review\]. Whilst relatively few studies have examined the effects of meditation on gait, a study of mindfulness---based cognitive therapy (MBCT) found the therapy normalized gait patterns in adults with a history of depression \[22\]. Additionally, a particular type of meditation, referred to as automatic self---transcending meditation (ASTM) has been shown to reduce symptoms of depression \[23\]. Currently, our research team is commencing the data collection phase of an REB approved study that has received funding by the Academic Medical Organization of Southwestern Ontario (AMOSO) Innovation Fund. This study is a single blind longitudinal naturalistic randomized control trial targeting individuals with late---life depression, and will examine the effects of ASTM on autonomic and mood---related symptoms of depression. In the framework of the ASTM study there is an opportunity to more closely examine the relationship between gait and depression in elderly populations, as well as the potential benefits of this mind---body therapy on gait and FOF. We are kindly requesting funding from the Department of Psychiatry to carry out this investigation. Specifically, we aim to assess gait parameters such as stride length and gait velocity, which have been shown to be affected by depression \[14, 15\], in LLD patients receiving ASTM training in addition to their current treatment schedules (ASTM group) as well as those that continue with their treatment as usual (TAU group). A thorough literature and clinical trial registry search reveals that no one has previously, or is currently, examining the effects of ASTM training on parameters of gait in LLD patients.

Eligibility criteria: Inclusion Criteria:

* participants must be at least 65 years of age
* have a diagnosis of mild to moderate MDD with a 17 item Hamilton Depression Rating Scale (HAMD-17) score of 8 to 22
* be of good general physical health
* have sufficient hearing to be able to follow verbal instructions
* be able to sit without physical discomfort for 45 minutes and be able to attend 4 initial ASTM training sessions. They must also agree to home practice of ASTM and to attend 75% of weekly follow-up sessions.

Exclusion Criteria:

* potential participants must also be free of any physical impairments that would cause discomfort/stress when walking or affect our ability to obtain a representative measure of gait including injuries of the spinal cord, leg or foot, muscular dystrophy, multiple sclerosis, spinal stenosis, scoliosis, spondylolithesis, and severe osteoarthritis or rheumatoid arthritis of the spine.

Primary outcomes:
measure: Change from baseline in mean stride length at 4 weeks
timeFrame: Week 4
measure: Change from baseline in mean stride length at 8 weeks
timeFrame: Week 8
measure: Change from baseline in mean stride length at 12 weeks
timeFrame: Week 12
measure: Change from baseline in mean stride length at 24 weeks
timeFrame: Week 24
Secondary outcomes:
measure: Change from baseline in gait velocity at 4 weeks
timeFrame: Week 4
measure: Change from baseline in gait velocity at 8 weeks
timeFrame: Week 8
measure: Change from baseline in gait velocity at 12 weeks
timeFrame: Week 12
measure: Change from baseline in gait velocity at 24 weeks
timeFrame: Week 24
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Akshya Vasudev, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Liu E, Vasudev A. Primary Care Companion CNS Disord. 2014;16(3). DOI: 10.4008/PCC.14/0. 2. Gupta A, Bevan R, Vasudev A. Clinical Governance. 2014;19(2):83. 3. Vasudev A, et al. Current Reviews in Psychiatry. Forthcoming 2014. 4. Maldeniya P, Vasudev A. Case Reports in Psychiatry, 2013;432568. 5. Vasudev A. 2013. Manic syndromes in old age; p581. 6. Vasudev A, et al. Cochrane Database of Systematic Reviews. 2013;4:CD010495. 7. Vasudev K, Vasudev A. Commentary on Mitchell AJ, et al. Br J Psychiatry, 2012 Dec;201:435. Evidence Based Mental Health. 2013;16(2):58. DOI: 10.1136/eb-2012. 8. Colloby SJ, Firbank MJ, He J, Thomas AJ, Vasudev A, et al. British Journal of Psychiatry. 2012;200:150. 9. Colloby SJ, Firbank MJ, Vasudev A, et al. Journal of Affective Disorders. 2012;133(1-2):158. 10. Vasudev A, et al. Cochrane Database of Systematic Reviews. 2012;12:CD004694. 11. Vasudev A, et al. American Journal of Geriatric Psychiatry. 2012;20(8):691. 12. Colloby SJ, Vasudev A, et al. British Journal of Psychiatry. 2011;199(5):404. 13. Colloby SJ, Firbank MJ, Thomas AJ, Vasudev A, et al. Journal of Affective Disorders. 2011;135(1-3):216. 14. Vasudev A, et al. Cochrane Database of Systematic Reviews. 011;12:CD004857. 15. Vasudev A, et al. Depression in diabetes of the older person. United Kingdom: Springer; 2011.