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Completed

NCT Number: NCT04701554

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

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lourdes Díaz Rodríguez

Granada, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Qigong program

Other

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.

Other

The control group received information on healthy lifestyles, physical exercise and dietary recommendations.

Primary outcomes

  1. Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 2 months.

    Time frame: 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.

  2. Change from Baseline in Happiness on the Lima happiness questionnaire after 2 months.

    Time frame: 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.

  3. Change from Baseline in Trial Making Test after 2 months.

    Time frame: 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.

  4. Change from Baseline in Heart rate variability after 2 months.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Consuelo Lourdes Díaz Rodríguez

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 8, 2021
Registry last updated
Jan 8, 2021

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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