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Neurophysiological RCT of Qigong in Elderly With Depression

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 2026 → Mar 2027
See other at-risk trials from The Hong Kong Polytechnic University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 2026 to Mar 2027
    • Secondary endpoints: details revised at 3 of 3 entries
    • Eligibility criteria expanded, about 2 words
  2. Primary and study completion dates: Mar 2025 to Mar 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  3. Primary and study completion dates: Dec 2024 to Mar 2025v7
  4. Primary completion date: Jul 31, 2024 to Dec 2024
    • Study completion date: Dec 31, 2024 to Dec 2024
    v6
  5. Primary completion date: Jul 31, 2023 to Jul 31, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Dec 31, 2022 to Jul 31, 2023
    • Study completion date: Jun 30, 2023 to Dec 31, 2023
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Aug 9, 2021
    • Site details revised
    v3
  3. Start date: Aug 2, 2021 to Sep 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Summary of Project: Elderly depression is a common mood disorder and the individuals will have persistent low mood and self-absorption that adversely affect their quality of life. Cognitive deficits including attention and executive function are commonly seen in elderly with depression. Qigong, a mind-body practice, is found to have an anti-depressive effect and improve cognitive functions. Yet, the underlying mechanism is still elusive. Hence, the present study aims to conduct a randomized controlled trial to investigate how the practice of Eight-Section Brocades, a type of qigong, affects the function of the central nervous system in elderly with depression, as measured by fNIRS. A total of 60 elderly (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 65 or above, with depressive mood as indicated by the Geriatric Depression Scale (GDS) will be recruited and randomly assigned to the treatment (eight-section brocades) and control (exercise) groups. We anticipate that this ancient Chinese mind-body based practice will result in (1) decreased depressive moods and improved cognitive functions, and (2) acute changes in the functional brain activation patterns in the PFC in elderly with depression. The results of this study will shed light on the neurophysiological underpinnings of the therapeutic effects associated with qigong, which will be invaluable for designing intervention for elderly with depression.
Trial Details
NCT Number NCT05000788
Lead Sponsor The Hong Kong Polytechnic University
Conditions
(from sponsor)		 Depression
Related terms Depression
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov