EFFECT OF A 16-SESSION QIGONG PROGRAM ON PHYSICAL AND MENTAL HEALTH IN PATIENTS WITH LYMPHOMA: A RANDOMIZED CONTROLLED TRIAL

Lymphoma Clinical Trial

Official title:

EFFECT OF A 16-SESSION QIGONG PROGRAM ON PHYSICAL AND MENTAL HEALTH IN PATIENTS WITH LYMPHOMA: A RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701554
• Other study ID #: 098988974
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: January 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 20, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older; lymphoma histology graded I to IIIA.

Exclusion Criteria:

• Treatment that modifies the vegetative nervous system activity; people that have previous experience in mind body practices.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• Qigong program
The intervention group received sixteen sessions lasting one hour with different techniques of diaphragmatic breathing, concentration techniques and exercises with smooth and coordinated musculoskeletal movements. The Qigong program was performed by a therapist with more than 10 years of experience.
• Information on healthy lifestyles, physical exercise and dietary recommendations.
The control group received information on healthy lifestyles, physical exercise and dietary recommendations.

Locations

Country	Name	City	State
Spain	Lourdes Díaz Rodríguez	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Consuelo Lourdes Díaz Rodríguez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) 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.	Baseline and after 2 months.
Primary	Change from Baseline in Happiness on the Lima happiness questionnaire 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.	Baseline and after 2 months.
Primary	Change from Baseline in Trial Making Test 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.	Baseline and after 2 months.
Primary	Change from Baseline in Heart rate variability 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.	Baseline and after 2 months.