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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800368
Other study ID # HKU_Psych
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 21, 2016
Est. completion date September 1, 2017

Study information

Verified date January 2019
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this randomized controlled trial (RCT) is to compare the changes of the sleep-related memory functions in patients with psychosis after they have completed the 12-week high-intensity exercise intervention, the 12-week low-intensity exercise intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one patients with psychosis, patients who received either the high-intensity exercise or low-intensity exercise as intervention shown a significant improvement to their impaired sleep-related memory function, while those who received non-exercise intervention has no such improvement. Moreover, high-intensity exercise may have a more prominent effect compare to low-intensity exercise.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Aged from 18 to 55

- Based on the SCID diagnosed to have schizophrenia and related psychotic disorders

- Ability to understand the nature of the study and to give written informed consent

Exclusion Criteria:

- Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders

- Comorbid substance dependence

- Unstable psychotic symptoms

- A history of brain trauma or organic brain disease

- Known history of intellectual disability or special school attendance

- Answered one or more "yes" in the PAR-Q and without doctors approval for exercise

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Indoor cycling exercise intervention
Non-exercise
Psycho-education

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Outcome

Type Measure Description Time frame Safety issue
Primary The sleep-dependent procedural memory consolidation after 12 weeks of intervention Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment. 12-week Follow-up
Secondary The verbal memory consolidation after 12 weeks of intervention Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment 12-week Follow-up
Secondary The attention performance after 12 weeks of intervention Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment 12-week Follow-up
Secondary The sleep quality after 12 weeks of intervention Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment 12-week Follow-up
Secondary The insomnia severity after 12 weeks of intervention Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment 12-week Follow-up
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