Trial Outcomes & Findings for Yoga and Aerobic Exercise in Psychosis (NCT NCT01207219)

NCT ID: NCT01207219

Last Updated: 2014-12-09

Results Overview

Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 140 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2014-12-09

Participant Flow

The recruitment period is from Oct 2010 to Jan 2013 in three outpatient clinics in Hong Kong.

In order to obtain sufficient imaging data for final analysis, a total of 140 patients were recruited and randomized, 16 of them withdrew before starting intervention. Amongst 124 participants, 9 were excluded from final analysis because of changed diagnosis during study period. 95 of 115 participants completed 12-week study.

Participant milestones

Measure	Yoga Therapy Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group Patients in waitlist were treated as usual and acted as the control group.
Overall Study STARTED	45	40	39
Overall Study Included in ITT Analysis	40	37	38
Overall Study COMPLETED	34	29	32
Overall Study NOT COMPLETED	11	11	7

Reasons for withdrawal

Measure	Yoga Therapy Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group Patients in waitlist were treated as usual and acted as the control group.
Overall Study changed diagnosis during study period	5	3	1
Overall Study Lost to Follow-up	6	8	6

Baseline Characteristics

Yoga and Aerobic Exercise in Psychosis

Baseline characteristics by cohort

Measure	Yoga Therapy n=40 Participants Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise n=37 Participants Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group n=38 Participants Patients in waitlist were treated as usual and acted as the control group.	Total n=115 Participants Total of all reporting groups
Age, Continuous	24.2 years STANDARD_DEVIATION 6.9 • n=5 Participants	23.6 years STANDARD_DEVIATION 5.6 • n=7 Participants	25.3 years STANDARD_DEVIATION 8.2 • n=5 Participants	24.4 years STANDARD_DEVIATION 7.0 • n=4 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	37 Participants n=7 Participants	38 Participants n=5 Participants	115 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Years of education	11.9 years STANDARD_DEVIATION 2.1 • n=5 Participants	12.8 years STANDARD_DEVIATION 3.2 • n=7 Participants	12.3 years STANDARD_DEVIATION 2.6 • n=5 Participants	12.3 years STANDARD_DEVIATION 2.7 • n=4 Participants
Length of illness	2.4 years STANDARD_DEVIATION 1.9 • n=5 Participants	2.5 years STANDARD_DEVIATION 2.0 • n=7 Participants	1.8 years STANDARD_DEVIATION 1.9 • n=5 Participants	1.8 years STANDARD_DEVIATION 1.9 • n=4 Participants
Smoking Never smoker	37 participants n=5 Participants	32 participants n=7 Participants	37 participants n=5 Participants	106 participants n=4 Participants
Smoking Past smoker	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Smoking Current smoker	3 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	8 participants n=4 Participants
Substance abuse No substance abuse	40 participants n=5 Participants	37 participants n=7 Participants	38 participants n=5 Participants	115 participants n=4 Participants
Substance abuse Substance abuse	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Diagnosis Schizophrenia	21 participants n=5 Participants	19 participants n=7 Participants	19 participants n=5 Participants	59 participants n=4 Participants
Diagnosis Schizoaffective disorder	4 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	13 participants n=4 Participants
Diagnosis Schizophreniform disorder	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Diagnosis Brief psychosis	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Diagnosis Psychosis not otherwise specified	13 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants	36 participants n=4 Participants
Diagnosis Delusional disorder	1 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Antipsychotic medication dose, Chlorpromazine (CPZ)	348 mg/day STANDARD_DEVIATION 268 • n=5 Participants	301 mg/day STANDARD_DEVIATION 245 • n=7 Participants	260 mg/day STANDARD_DEVIATION 211 • n=5 Participants	305 mg/day STANDARD_DEVIATION 244 • n=4 Participants
Positive and Negative Syndrome Scale (PANSS) total score	46.9 units on a scale STANDARD_DEVIATION 15.8 • n=5 Participants	46.8 units on a scale STANDARD_DEVIATION 16.4 • n=7 Participants	45.4 units on a scale STANDARD_DEVIATION 15.2 • n=5 Participants	46.4 units on a scale STANDARD_DEVIATION 15.7 • n=4 Participants
Calgary Depression Scale (CDS) total score	3.6 units on a scale STANDARD_DEVIATION 3.4 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 4.1 • n=7 Participants	3.7 units on a scale STANDARD_DEVIATION 4.7 • n=5 Participants	3.6 units on a scale STANDARD_DEVIATION 4.1 • n=4 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.

Outcome measures

Measure	Yoga Therapy n=40 Participants Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise n=37 Participants Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group n=38 Participants Patients in waitlist were treated as usual and acted as the control group.
Verbal Acquisition Baseline	22.8 correctly encoded words Standard Deviation 5.8	22.0 correctly encoded words Standard Deviation 7.8	22.7 correctly encoded words Standard Deviation 7.7
Verbal Acquisition 12 weeks	29.5 correctly encoded words Standard Deviation 6.3	28.8 correctly encoded words Standard Deviation 8.2	24.8 correctly encoded words Standard Deviation 8.2

PRIMARY outcome

Timeframe: baseline and 12 weeks

The total number of correctly recalled words after short-term (10 minutes) and long-term (30 minutes) delay in the random condition of Hong Kong List Learning test.

Outcome measures

Measure	Yoga Therapy n=40 Participants Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise n=37 Participants Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group n=38 Participants Patients in waitlist were treated as usual and acted as the control group.
Verbal Retention Baseline	14.9 correctly recorded words Standard Deviation 5.7	15.1 correctly recorded words Standard Deviation 5.1	14.5 correctly recorded words Standard Deviation 7.0
Verbal Retention 12 weeks	19.4 correctly recorded words Standard Deviation 5.9	21.0 correctly recorded words Standard Deviation 7.2	16.6 correctly recorded words Standard Deviation 7.3

PRIMARY outcome

Timeframe: baseline and 12 weeks

measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.

Outcome measures

Measure	Yoga Therapy n=40 Participants Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise n=37 Participants Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group n=38 Participants Patients in waitlist were treated as usual and acted as the control group.
Working Memory Baseline	6.8 Scores on a scale Standard Deviation 2.7	6.8 Scores on a scale Standard Deviation 2.5	7.1 Scores on a scale Standard Deviation 3.3
Working Memory 12 weeks	8.5 Scores on a scale Standard Deviation 2.9	9.4 Scores on a scale Standard Deviation 2.9	7.7 Scores on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: baseline and 12 weeks

measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter "C" and "E" as quickly as possible. The time to completion, number of error and omission items were recorded. A "quality of search" index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome).

Outcome measures

Measure	Yoga Therapy n=40 Participants Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise n=37 Participants Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group n=38 Participants Patients in waitlist were treated as usual and acted as the control group.
Attention and Concentration Baseline	0.76 Correct number per second Standard Deviation 0.14	0.71 Correct number per second Standard Deviation 0.22	0.74 Correct number per second Standard Deviation 0.15
Attention and Concentration 12 weeks	0.84 Correct number per second Standard Deviation 0.18	0.77 Correct number per second Standard Deviation 0.19	0.73 Correct number per second Standard Deviation 0.17

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: One subject in the waitlist control group has not completed all measures both at the baseline and 12 weeks. Measure of clinical severity has been missing in the data set. So that there are 37 subjects' data of clinical severity has been included for analysis.

PANSS total score is computed by summing the scores of positive, negative and general symptom subscores. The range of PANSS total score is from 30 to 210, range of PANSS positive and negative subscores is from 7 to 49, range of PANSS general symptoms subscore is from 16 to 112, with higher values representing worse outcome. CDS total score is computed by summing the scores of nine items of the scale. The range of CDS total score is from 0 to 27, with higher values representing worse outcome.

Outcome measures

Measure	Yoga Therapy n=40 Participants Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.	Aerobic Exercise n=37 Participants Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.	Waitlist Control Group n=37 Participants Patients in waitlist were treated as usual and acted as the control group.
Severity of Symptoms PANSS total score-Baseline	46.9 units on a scale Standard Deviation 15.8	46.8 units on a scale Standard Deviation 16.4	45.4 units on a scale Standard Deviation 15.2
Severity of Symptoms PANSS total score-12 weeks	37.4 units on a scale Standard Deviation 9.6	39.5 units on a scale Standard Deviation 11.1	49.0 units on a scale Standard Deviation 15.8
Severity of Symptoms PANSS positive subscore-Baseline	9.9 units on a scale Standard Deviation 3.5	9.7 units on a scale Standard Deviation 4.6	9.8 units on a scale Standard Deviation 3.8
Severity of Symptoms PANSS positive subscore-12 weeks	8.4 units on a scale Standard Deviation 2.5	8.3 units on a scale Standard Deviation 2.5	10.0 units on a scale Standard Deviation 3.5
Severity of Symptoms PANSS negative subscore-Baseline	11.0 units on a scale Standard Deviation 4.3	11.2 units on a scale Standard Deviation 5.7	11.2 units on a scale Standard Deviation 4.1
Severity of Symptoms PANSS negative subscore-12 weeks	8.7 units on a scale Standard Deviation 2.8	9.7 units on a scale Standard Deviation 3.8	12.6 units on a scale Standard Deviation 5.1
Severity of Symptoms PANSS general symptoms-Baseline	26.0 units on a scale Standard Deviation 9.5	25.9 units on a scale Standard Deviation 9.5	24.5 units on a scale Standard Deviation 9.2
Severity of Symptoms PANSS general symptoms-12 weeks	20.3 units on a scale Standard Deviation 5.6	21.6 units on a scale Standard Deviation 6.9	26.4 units on a scale Standard Deviation 9.6
Severity of Symptoms CDS-Baseline	3.6 units on a scale Standard Deviation 3.4	3.4 units on a scale Standard Deviation 4.1	3.7 units on a scale Standard Deviation 4.7
Severity of Symptoms CDS-12 weeks	1.7 units on a scale Standard Deviation 2.5	1.7 units on a scale Standard Deviation 2.4	4.3 units on a scale Standard Deviation 4.3

Adverse Events

Yoga Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aerobic Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Lin Jingxia

The Department of Psychiatry,HKU

Phone: +85222553064

Email: jingxia.lin@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place