Gait, Depression, and Mind-body Therapy in Seniors

NCT02283541 | Completed

• 1 other identifier: HSREB 105915
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Gait; late life depression; mind-body therapies

Outcome Measures

Primary Outcomes (4)

• 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

• Change from baseline in mean stride length at 8 weeks

  As above

  Week 8

• Change from baseline in mean stride length at 12 weeks

  As above

  Week 12

• Change from baseline in mean stride length at 24 weeks

  As above

  Week 24

Secondary Outcomes (4)

• Change from baseline in gait velocity at 4 weeks

  Week 4

• Change from baseline in gait velocity at 8 weeks

  Week 8

• Change from baseline in gait velocity at 12 weeks

  Week 12

• Change from baseline in gait velocity at 24 weeks

  Week 24

Study Arms (2)

ASTM

EXPERIMENTAL

Participants in Automatic self-transcending meditation (ASTM) arm will complete a 12 week meditation training program in addition to their existing treatment plan. This involves participating in 120-minute sessions on each of four consecutive days of the first week. Participants will individually be given a mantra on day one, and then be instructed in use of the mantra according to specific criteria over the four session program. This will be followed by weekly 60-minute follow up sessions for the 11 subsequent weeks. In addition, participants will be asked to practice ASTM at home for 20 minutes twice daily over the study period. Assessments of depression severity will be completed at specific times over the 12 week training period: at Weeks 0, 4, 8 and 12.

Behavioral: Automatic self-transcending meditation

TAU

NO INTERVENTION

Participants in TAU arm will continue with their existing treatment schedule as usual. Assessments of depression severity will be completed at specific times over the 12 week training period: at Weeks 0, 4, 8 and 12. However, no assessments will be done or information collected on the TAU arm from week 12 onwards. After week 12, TAU arm participants will be offered the opportunity to learn ASTM and attend follow up meditation.

Interventions

Automatic self-transcending meditation BEHAVIORAL

ASTM is a category of meditation that helps quiet the mind and induce physiological and mental relaxation while the eyes are shut. It utilizes relaxed attention to a specific sound value (mantra) according to specific criteria, in order to draw attention inward.

Also known as: ASTM

ASTM

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Akshya Vasudev, MBBS, MD

  London Health Sciences Centre

  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: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 5, 2014
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

CA (1)