Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03345563 · ADVERSE EVENTS

Adverse events

Project HERO: Health Empowerment & Recovery Outcomes · Source last updated 2026-07-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Time of enrollment to study completion, an average of 12 months
Other-event reporting threshold
0%

No adverse event was noted in the trial. However, an all-cause mortality event occurred in the BT arm, unrelated to the intervention or the trial.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Usual Care (UC/Control)

Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.

0 / 250 / 250 / 25
Body Training (BT/Exercise Intensity-Matched Control)

Participants engaged in instructor-led stretching and controlled movements twice weekly for 12 weeks, matched to the physical intensity of BMT without the mindfulness components.

0 / 430 / 431 / 43
Body-Mind Training (BMT/Tai Chi Qigong)

Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.

0 / 450 / 450 / 45

Group identifiers: EG000: Usual Care (UC/Control) · EG001: Body Training (BT/Exercise Intensity-Matched Control) · EG002: Body-Mind Training (BMT/Tai Chi Qigong)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      No adverse event was noted in the trial. However, an all-cause mortality event occurred in the BT arm, unrelated to the intervention or the trial.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        25
        description
        Participants continued with their routine medical care and received no structured exercise or mind-body intervention during the study period.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        25
        serious Num Affected
        0
        serious Num At Risk
        25
        title
        Usual Care (UC/Control)
      2. deaths Num Affected
        1
        deaths Num At Risk
        43
        description
        Participants engaged in instructor-led stretching and controlled movements twice weekly for 12 weeks, matched to the physical intensity of BMT without the mindfulness components.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        43
        serious Num Affected
        0
        serious Num At Risk
        43
        title
        Body Training (BT/Exercise Intensity-Matched Control)
      3. deaths Num Affected
        0
        deaths Num At Risk
        45
        description
        Participants attended instructor-led Tai Chi Qigong sessions twice weekly for 12 weeks, incorporating meditative movement, controlled breathing, and relaxation.
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        45
        serious Num Affected
        0
        serious Num At Risk
        45
        title
        Body-Mind Training (BMT/Tai Chi Qigong)
      frequency Threshold
      0
      time Frame
      Time of enrollment to study completion, an average of 12 months

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice