Major Depressive Disorder Clinical Trial
Official title:
Investigating the Relationship Between Gait, Depression, and Mind-body Therapy in Seniors
Verified date | August 2017 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in mean stride length at 4 weeks | Participants will be asked to complete three walks at their normal pace, beginning and ending 1m from the walkway to account for acceleration and deceleration. Baseline measures of mean stride length and gait velocity will be obtained. A mean gait velocity less than 100cm/s will be classified as a gait disorder | Week 4 | |
Primary | Change from baseline in mean stride length at 8 weeks | As above | Week 8 | |
Primary | Change from baseline in mean stride length at 12 weeks | As above | Week 12 | |
Primary | Change from baseline in mean stride length at 24 weeks | As above | Week 24 | |
Secondary | Change from baseline in gait velocity at 4 weeks | As above | Week 4 | |
Secondary | Change from baseline in gait velocity at 8 weeks | As above | Week 8 | |
Secondary | Change from baseline in gait velocity at 12 weeks | As above | Week 12 | |
Secondary | Change from baseline in gait velocity at 24 weeks | As above | Week 24 |
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