Trial Outcomes & Findings for Brain Connectivity and Response to Tai Chi in Geriatric Depression (NCT NCT02460666)

Last Updated: 2021-07-16

Results Overview

Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: \[0-2\], \[0-3\], and \[0-4\]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range \[0-74\], higher scores representing more severe difficulties.

Recruitment status

COMPLETED

Study phase

Target enrollment

220 participants

Primary outcome timeframe

Measured at baseline and 3 months

Results posted on

2021-07-16

Participant Flow

220 participants were enrolled after providing consent and completing the screen visit. 178 participants completed baseline procedures and were randomized to either group.

Participant milestones

Participant milestones
Measure	Tai-Chi Chih Classes Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)
Overall Study STARTED	89	89
Overall Study COMPLETED	62	63
Overall Study NOT COMPLETED	27	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Connectivity and Response to Tai Chi in Geriatric Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tai-Chi Chih Classes n=89 Participants Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes n=89 Participants Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)	Total n=178 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 6.9 • n=93 Participants	69.4 years STANDARD_DEVIATION 6.2 • n=4 Participants	69.3 years STANDARD_DEVIATION 6.6 • n=27 Participants
Sex: Female, Male Female	62 Participants n=93 Participants	67 Participants n=4 Participants	129 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	22 Participants n=4 Participants	49 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=93 Participants	85 Participants n=4 Participants	168 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) White	76 Participants n=93 Participants	77 Participants n=4 Participants	153 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	89 participants n=93 Participants	89 participants n=4 Participants	178 participants n=27 Participants
Hamilton Depression Rating Scale	19.0 units on a scale STANDARD_DEVIATION 4.0 • n=93 Participants	19.3 units on a scale STANDARD_DEVIATION 3.9 • n=4 Participants	19.15 units on a scale STANDARD_DEVIATION 3.91 • n=27 Participants

PRIMARY outcome

Timeframe: Measured at baseline and 3 months

Outcome measures

Outcome measures
Measure	Tai-Chi Chih Classes n=62 Participants Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes n=63 Participants Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)
Change in Hamilton Depression Rating Scale (HDRS) Scores	-9.27 units on a scale Standard Deviation 5.29	-9.40 units on a scale Standard Deviation 5.35

SECONDARY outcome

Timeframe: Measured at baseline and 3 months

Neuropsychological battery of tests which included the following domains: Delayed Recall (CVLT-II \[Long-Delay Free Recall\], Rey-Osterrieth Complex Figure Test \[30-minute Delayed Recall\]) Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance.

Outcome measures

Outcome measures
Measure	Tai-Chi Chih Classes n=62 Participants Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes n=63 Participants Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)
Change in Delayed Recall Cognitive Domain Scores	-0.15 z-score Standard Deviation 0.57	-0.002 z-score Standard Deviation 0.61

SECONDARY outcome

Timeframe: Measured at baseline and 3 months

Neuropsychological battery of tests which included the following domains: Attention/Executive Function (Trail Making Test A and B, Stroop Interference \[Golden version\]) Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance.

Outcome measures

Outcome measures
Measure	Tai-Chi Chih Classes n=62 Participants Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes n=63 Participants Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)
Change in Attention/Executive Function Cognitive Domain Scores	-0.04 z-score Standard Deviation 0.61	0.03 z-score Standard Deviation 0.53

SECONDARY outcome

Timeframe: Measured at baseline and 3 months

Neuropsychological battery of tests which included the following domains: Language (Controlled Oral Word Association test \[FAS\], Animal Fluency, and Boston Naming Test) Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. Thus the sample mean (across both arms) is zero for each test score. These z-scores were then averaged within each neuropsychological domain to produce composite scores. Higher scores are indicative of better performance.

Outcome measures

Outcome measures
Measure	Tai-Chi Chih Classes n=62 Participants Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes n=63 Participants Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)
Change in Language Cognitive Domain Scores	0.03 z-score Standard Deviation 0.40	-0.12 z-score Standard Deviation 0.46

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at 3 months

The UKU (Udvalg for Kliniske Undersogelser) Side Effect Rating Scale organizes symptoms into 4 categories (i.e., Psychic, Neurologic, Autonomic, Other) containing 8-19 symptoms each. Each symptom receives a score for degree and causal relationship. Degree is scored between 0-3 with higher scores being more severe. Causal relationship is scored as improbable, possible, or probable.

Outcome measures

Outcome measures
Measure	Tai-Chi Chih Classes n=89 Participants Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes n=89 Participants Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)
Number of Participants With Adverse Events	4 Participants	3 Participants

Adverse Events

Tai-Chi Chih Classes

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Health Education and Wellness Classes

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tai-Chi Chih Classes n=89 participants at risk Participants will engage in 12 weekly 60 minute Tai-Chi-Chih classes. Tai-Chi-Chih (TCC)	Health Education and Wellness Classes n=89 participants at risk Participants will engage in 12 weekly 60 minute Health Education and Wellness classes. Health Education and Wellness Classes (HEW)
Musculoskeletal and connective tissue disorders Asthenia/Lassitude/Increased Fatigability	4.5% 4/89 • Number of events 4 • Adverse event data was collected over the course of 6 months, from the time the participants began the intervention until the Week 24 follow-up. Adverse events were obtained via the UKU Side Effect Rating Scale, where items were scored on a 0-3 scale for degree (0 = none, 1 = mild, 2 = moderate, 3 = severe) and on a scale of 1-3 of probability if an adverse event was present (1 = impossibly related, 2 = possibly related, 3 = probably related).	0.00% 0/89 • Adverse event data was collected over the course of 6 months, from the time the participants began the intervention until the Week 24 follow-up. Adverse events were obtained via the UKU Side Effect Rating Scale, where items were scored on a 0-3 scale for degree (0 = none, 1 = mild, 2 = moderate, 3 = severe) and on a scale of 1-3 of probability if an adverse event was present (1 = impossibly related, 2 = possibly related, 3 = probably related).
Psychiatric disorders Failing memory	0.00% 0/89 • Adverse event data was collected over the course of 6 months, from the time the participants began the intervention until the Week 24 follow-up. Adverse events were obtained via the UKU Side Effect Rating Scale, where items were scored on a 0-3 scale for degree (0 = none, 1 = mild, 2 = moderate, 3 = severe) and on a scale of 1-3 of probability if an adverse event was present (1 = impossibly related, 2 = possibly related, 3 = probably related).	1.1% 1/89 • Number of events 1 • Adverse event data was collected over the course of 6 months, from the time the participants began the intervention until the Week 24 follow-up. Adverse events were obtained via the UKU Side Effect Rating Scale, where items were scored on a 0-3 scale for degree (0 = none, 1 = mild, 2 = moderate, 3 = severe) and on a scale of 1-3 of probability if an adverse event was present (1 = impossibly related, 2 = possibly related, 3 = probably related).
Psychiatric disorders Tension/Inner Unrest	0.00% 0/89 • Adverse event data was collected over the course of 6 months, from the time the participants began the intervention until the Week 24 follow-up. Adverse events were obtained via the UKU Side Effect Rating Scale, where items were scored on a 0-3 scale for degree (0 = none, 1 = mild, 2 = moderate, 3 = severe) and on a scale of 1-3 of probability if an adverse event was present (1 = impossibly related, 2 = possibly related, 3 = probably related).	2.2% 2/89 • Number of events 2 • Adverse event data was collected over the course of 6 months, from the time the participants began the intervention until the Week 24 follow-up. Adverse events were obtained via the UKU Side Effect Rating Scale, where items were scored on a 0-3 scale for degree (0 = none, 1 = mild, 2 = moderate, 3 = severe) and on a scale of 1-3 of probability if an adverse event was present (1 = impossibly related, 2 = possibly related, 3 = probably related).

Additional Information

Helen Lavretsky, MD

University of California, Los Angeles

Phone: (310) 794-4619

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place