EFFECT OF A 16-SESSION QIGONG PROGRAM ON PHYSICAL AND MENTAL HEALTH IN PATIENTS WITH LYMPHOMA: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change from Baseline in Trial Making Test after 2 months.
研究概览
简要总结
The aim of the present study was to investigate in lymphoma patients the effects of a 16-session qigong programme (2 times a week) on physical and psychological parameters.
详细描述
A randomized controlled trial was conducted (control group = 19; intervention = 20). Initially 50 patients enrolled in this study but only 39 finalized the program. 52% male and 48% female with a mean (SD) age of 44.49 (10.60) years. People who have had previous experiencie in mind body practices were excluded. All the patientes received information about the study and informed consent was obtained from all participants. This study was approved by the CEI-GR (C-9) ethics committee and followed the principies of the Declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older; lymphoma histology graded I to IIIA.
排除标准
- •Treatment that modifies the vegetative nervous system activity; people that have previous experience in mind body practices.
研究组 & 干预措施
Qigong program
The experimental group participated in the Qigong program during 2 months, 16 sessions with a total of 16 hours.
干预措施: Qigong program (Other)
Active comparator group
The control group received information on healthy lifestyles, physical exercise and dietary recommendations.
干预措施: Information on healthy lifestyles, physical exercise and dietary recommendations. (Other)
结局指标
主要结局
Change from Baseline in Trial Making Test after 2 months.
时间窗: Baseline and after 2 months.
A neuropsychological test of visual attention and task switching where the subject is instructed to connect a set of 25 dots as quickly as possible on a sheet of paper. In the first part of the test, the targets are all numbers from 1 to 25 and the test taker needs to connect them in sequential order; in the second part, the dots go from 1 to 13 and include letters from A to L. The patient must connect the dots in order, alternating letters and numbers, as in 1-A-2-B-3-C in the shortest time possible without lifting the pen from the paper. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.
Change from Baseline in Heart rate variability after 2 months.
时间窗: Baseline and after 2 months.
We measured short-term HRV using an accepted method in order to assess the cardiovascular balance (Kappussami 2020). We asked participants to lie in a supine position for 10 min of rest with normal breathing (following a metronome at 0.2 Hz) and no external stimulation in a quiet room with a temperature of 22-25 ºC.
Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 2 months.
时间窗: Baseline and after 2 months.
Validated self-administered instrument for outpatients that advises on the possible presence of anxiety and depression in any non-psychiatric medical consultation. Describe how the patients feel affective and emotionally during the last week. It has 14 items, 7 for each subscale with a scale similar to four points (from 0 to 3). Lower scores reflect better outcomes.
Change from Baseline in Happiness on the Lima happiness questionnaire after 2 months.
时间窗: Baseline and after 2 months.
Validated self-administered questionnaire consisting of 27 items, integrated into 4 subscales (positive sense of life, satisfaction with life, personal fulfillment and Joy of life), which refer to the level of happiness or satisfaction that the person has with respect to his life. The respondent may be: (1) strongly agree, (2) agree, (3) neither agree nor disagree, (4) disagree or (5) strongly disagree, with any question that arises. According to the total score there are 5 levels of happiness: from 27-87 very low happiness; 88-95 low; 96-110 medium; 111-118 high;119-135 very high.
次要结局
未报告次要终点
研究者
Consuelo Lourdes Díaz Rodríguez
Dr. Consuelo Lourdes Díaz Rodríguez
Universidad de Granada