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OpenTrials
Completed

NCT Number: NCT03800368

Exercise and Overnight Motor Sequence Task

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Indoor cycling exercise intervention

Non-exercise

Other

Psycho-education

Primary outcomes

  1. The sleep-dependent procedural memory consolidation after 12 weeks of intervention

    Time frame: 12-week Follow-up

    Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.

Secondary outcomes

  1. The verbal memory consolidation after 12 weeks of intervention

    Time frame: 12-week Follow-up

    Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment

  2. The attention performance after 12 weeks of intervention

    Time frame: 12-week Follow-up

    Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment

  3. The sleep quality after 12 weeks of intervention

    Time frame: 12-week Follow-up

    Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment

  4. The insomnia severity after 12 weeks of intervention

    Time frame: 12-week Follow-up

    Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

12-week Aerobic-Anaerobic Transition Exercise Intervention and Overnight Sleep-dependent Procedural Memory Consolidation in Patients With Schizophrenia

Acronym: EOMST

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2019
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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