Back to resultsEFFECT OF A 16-SESSION QIGONG PROGRAM ON PHYSICAL AND MENTAL HEALTH IN PATIENTS WITH LYMPHOMA: A RANDOMIZED CONTROLLED TRIAL
Primary Purpose
Lymphoma
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Qigong program
Information on healthy lifestyles, physical exercise and dietary recommendations.
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Lourdes Díaz Rodríguez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Qigong program
Active comparator group
Arm Description
The experimental group participated in the Qigong program during 2 months, 16 sessions with a total of 16 hours.
The control group received information on healthy lifestyles, physical exercise and dietary recommendations.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04701554
First Posted
January 6, 2021
Last Updated
January 6, 2021
Sponsor
Consuelo Lourdes Díaz Rodríguez
1. Study Identification
Unique Protocol Identification Number
NCT04701554
Brief Title
EFFECT OF A 16-SESSION QIGONG PROGRAM ON PHYSICAL AND MENTAL HEALTH IN PATIENTS WITH LYMPHOMA: A RANDOMIZED CONTROLLED TRIAL
Official Title
EFFECT OF A 16-SESSION QIGONG PROGRAM ON PHYSICAL AND MENTAL HEALTH IN PATIENTS WITH LYMPHOMA: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
May 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Consuelo Lourdes Díaz Rodríguez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A ramdomized controlled trial.
Masking
Investigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qigong program
Arm Type
Experimental
Arm Description
The experimental group participated in the Qigong program during 2 months, 16 sessions with a total of 16 hours.
Arm Title
Active comparator group
Arm Type
Active Comparator
Arm Description
The control group received information on healthy lifestyles, physical exercise and dietary recommendations.
Intervention Type
Other
Intervention Name(s)
Qigong program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information on healthy lifestyles, physical exercise and dietary recommendations.
Intervention Description
The control group received information on healthy lifestyles, physical exercise and dietary recommendations.
Primary Outcome Measure Information:
Title
Change from Baseline in Anxiety and Depression on the Hospital Anxiety and Depression Scale (HADS) after 2 months.
Description
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.
Time Frame
Baseline and after 2 months.
Title
Change from Baseline in Happiness on the Lima happiness questionnaire after 2 months.
Description
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.
Time Frame
Baseline and after 2 months.
Title
Change from Baseline in Trial Making Test after 2 months.
Description
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.
Time Frame
Baseline and after 2 months.
Title
Change from Baseline in Heart rate variability after 2 months.
Description
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.
Time Frame
Baseline and after 2 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lourdes Díaz Rodríguez
City
Granada
ZIP/Postal Code
18016
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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EFFECT OF A 16-SESSION QIGONG PROGRAM ON PHYSICAL AND MENTAL HEALTH IN PATIENTS WITH LYMPHOMA: A RANDOMIZED CONTROLLED TRIAL
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