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

NCT04701554 | Completed

• 1 other identifier: 098988974
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Qigong program

EXPERIMENTAL

The experimental group participated in the Qigong program during 2 months, 16 sessions with a total of 16 hours.

Other: Qigong program

Active comparator group

ACTIVE COMPARATOR

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

Other: Information on healthy lifestyles, physical exercise and dietary recommendations.

Interventions

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.

Qigong program

Information on healthy lifestyles, physical exercise and dietary recommendations. OTHER

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

Active comparator group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Consuelo Lourdes Díaz Rodríguez: lead

Study Sites (1)

Lourdes Díaz Rodríguez

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Consuelo Lourdes Díaz Rodríguez

Model Details: A ramdomized controlled trial.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: December 1, 2019
• Primary Completion: April 10, 2020
• Study Completion: May 20, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

ES (1)