NCT05081297

Brief Summary

The objective of the study is to understand if Qigong may be useful in controlling the psychological state of participants in relative social isolation (during Covid-19 governmental imposed isolation procedures) The sessions are conducted live by the internet by a professional instructor-therapist with the duration of 2 months and a regular minimum of 2 sessions a week.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

September 23, 2021

Last Update Submit

January 28, 2022

Conditions

Mental Health Wellness 1

Keywords

QigongMental healthsocial isolationTraditional vegetative biofeedback therapy

Outcome Measures

Primary Outcomes (4)

  • Psychological Well-being (Mental health Inventory (MHI) dimension)

    A higher score means a higher Psychological Well-being (0-100 score)

    T0 - Baseline week 0

  • Psychological Well-being (Mental health Inventory (MHI) dimension)

    A higher score means a higher Psychological Well-being (0-100 score)

    T1 - 8 weeks

  • Psychological Distress (Mental health Inventory (MHI) dimension)

    A higher score means a higher Psychological Distress (0-100 score)

    T0 - Baseline week 0

  • Psychological Distress (Mental health Inventory (MHI) dimension)

    A higher score means a higher Psychological Distress (0-100 score)

    T1 - 8 weeks

Secondary Outcomes (10)

  • Positive Affect (Mental health Inventory (MHI) dimension)

    T0 - Baseline week 0

  • Positive Affect (Mental health Inventory (MHI) dimension)

    T1 - 8 weeks

  • Emotional Ties (Mental health Inventory (MHI) dimension)

    T0 - Baseline week 0

  • Emotional Ties (Mental health Inventory (MHI) dimension)

    T1 - 8 weeks

  • Loss of emotional or behavioral control (Mental health Inventory (MHI) dimension)

    T0 - Baseline week 0

  • +5 more secondary outcomes

Study Arms (3)

Qigong practitioner group

EXPERIMENTAL

This arm is the experimental group where qigong intervention is going to be applied to practitioners with experience

Other: Qigong

No practice

NO INTERVENTION

This group has no intervention and acts as control

Beginner Qigong practitioner group

EXPERIMENTAL

This arm is the experimental group where qigong intervention is going to be applied to practitioners with no experience.

Other: Qigong

Interventions

QigongOTHER

Qigong as a traditional chinese medicine technique, composed of several types of exercises: Baduanjin, taijiquan, yijinjing, baojiangong.

Also known as: Traditional vegetative biofeedback therapy, Chikung, Taichi
Beginner Qigong practitioner groupQigong practitioner group

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Physical or mental disabilities or conditions that may aggravate when performing semi-supervised physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Português de Taichi e Chikung

Maia, Porto District, 4470-765, Portugal

Location

MeSH Terms

Conditions

Psychological Well-BeingSocial Isolation

Interventions

Qigong

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Jorge Machado, PhD

    ICBAS - Instituto de Ciências Biomédicas Abel Salazar

    STUDY DIRECTOR

  • Lara Lopes, MSc

    ICBAS - Instituto de Ciências Biomédicas Abel Salazar

    PRINCIPAL INVESTIGATOR

  • Jorge M Rodrigues, BSc

    ICBAS - Instituto de Ciências Biomédicas Abel Salazar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 18, 2021

Study Start

July 2, 2020

Primary Completion

October 30, 2020

Study Completion

October 31, 2020

Last Updated

February 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)