- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05081297
Qigong and Social Isolation: Mental Health Benefits
Qigong Effects on Mental Health of People Under Relative Isolation
Study Overview
Detailed Description
The study's objective is to understand if Qigong may be helpful on the psychological state control of the participants in a relative state of isolation imposed by the government on the fight against Covid-19.
Data is gathered via the Mental Health Inventory (MHI) adapted to the Portuguese population to assess quantitative mental health scores and a simple structured interview to assess qualitative mental health benefits of Chikung (Qigong).
Qigong was the chosen technique to be studied as an intervention. Qigong is a Traditional Chinese Medicine therapeutic tool that has been studied for its several health benefits. As a traditional vegetative biofeedback therapy, Qigong can be useful for the maintenance of mental health of people with several conditions such as anxiety and depression, autism spectrum disorder and even conditions related to behavioral control.
- Group 1 was composed of Qigong practitioners (for at least 3 months).
- Group 2 was composed of participants who would receive the Qigong intervention (never practiced Qigong).
- Group 3 was composed of control participants (who would not receive the intervention).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Porto
-
Maia, Porto, Portugal, 4470-765
- Instituto Português de Taichi e Chikung
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Exclusion Criteria:
- Physical or mental disabilities or conditions that may aggravate when performing semi-supervised physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Qigong practitioner group
This arm is the experimental group where qigong intervention is going to be applied to practitioners with experience
|
Qigong as a traditional chinese medicine technique, composed of several types of exercises: Baduanjin, taijiquan, yijinjing, baojiangong.
Other Names:
|
|
NO_INTERVENTION: No practice
This group has no intervention and acts as control
|
|
|
EXPERIMENTAL: Beginner Qigong practitioner group
This arm is the experimental group where qigong intervention is going to be applied to practitioners with no experience.
|
Qigong as a traditional chinese medicine technique, composed of several types of exercises: Baduanjin, taijiquan, yijinjing, baojiangong.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-being (Mental health Inventory (MHI) dimension)
Time Frame: T0 - Baseline week 0
|
A higher score means a higher Psychological Well-being (0-100 score)
|
T0 - Baseline week 0
|
|
Psychological Well-being (Mental health Inventory (MHI) dimension)
Time Frame: T1 - 8 weeks
|
A higher score means a higher Psychological Well-being (0-100 score)
|
T1 - 8 weeks
|
|
Psychological Distress (Mental health Inventory (MHI) dimension)
Time Frame: T0 - Baseline week 0
|
A higher score means a higher Psychological Distress (0-100 score)
|
T0 - Baseline week 0
|
|
Psychological Distress (Mental health Inventory (MHI) dimension)
Time Frame: T1 - 8 weeks
|
A higher score means a higher Psychological Distress (0-100 score)
|
T1 - 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Affect (Mental health Inventory (MHI) dimension)
Time Frame: T0 - Baseline week 0
|
A higher score means a higher Positive Affect (0-100 score)
|
T0 - Baseline week 0
|
|
Positive Affect (Mental health Inventory (MHI) dimension)
Time Frame: T1 - 8 weeks
|
A higher score means a higher Positive Affect (0-100 score)
|
T1 - 8 weeks
|
|
Emotional Ties (Mental health Inventory (MHI) dimension)
Time Frame: T0 - Baseline week 0
|
A higher score means higher Emotional Ties (0-100 score)
|
T0 - Baseline week 0
|
|
Emotional Ties (Mental health Inventory (MHI) dimension)
Time Frame: T1 - 8 weeks
|
A higher score means higher Emotional Ties (0-100 score)
|
T1 - 8 weeks
|
|
Loss of emotional or behavioral control (Mental health Inventory (MHI) dimension)
Time Frame: T0 - Baseline week 0
|
A higher score means a higher Loss of emotional or behavioral control (0-100 score)
|
T0 - Baseline week 0
|
|
Loss of emotional or behavioral control (Mental health Inventory (MHI) dimension)
Time Frame: T1 - 8 weeks
|
A higher score means a higher Loss of emotional or behavioral control (0-100 score)
|
T1 - 8 weeks
|
|
Anxiety (Mental health Inventory (MHI) dimension)
Time Frame: T0 - Baseline week 0
|
A higher score means higher Anxiety levels (0-100 score)
|
T0 - Baseline week 0
|
|
Anxiety (Mental health Inventory (MHI) dimension)
Time Frame: T1 - 8 weeks
|
A higher score means higher Anxiety levels (0-100 score)
|
T1 - 8 weeks
|
|
Depression (Mental health Inventory (MHI) dimension)
Time Frame: T0 - Baseline week 0
|
A higher score means higher Depression levels (0-100 score)
|
T0 - Baseline week 0
|
|
Depression (Mental health Inventory (MHI) dimension)
Time Frame: T1 - 8 weeks
|
A higher score means higher Depression levels (0-100 score)
|
T1 - 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jorge Machado, PhD, ICBAS - Instituto de Ciências Biomédicas Abel Salazar
- Principal Investigator: Lara Lopes, MSc, ICBAS - Instituto de Ciências Biomédicas Abel Salazar
- Principal Investigator: Jorge M Rodrigues, BSc, ICBAS - Instituto de Ciências Biomédicas Abel Salazar
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- QgIsolationMentalHealth
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health Wellness 1
-
Indiana UniversityCommunity Health Network; Boys & Girls Clubs of IndianapolisCompletedMental Health Wellness 1 | Child Behavior | Adolescent Behavior | Mental Health Wellness 2United States
-
Cedars-Sinai Medical CenterNot yet recruitingMental Health Wellness 1 | Wellness, PsychologicalUnited States
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Universiti Putra MalaysiaGreen International UniversityNot yet recruitingMental Health Wellness 1
-
Northern Arizona UniversityUniversity of Colorado, DenverRecruiting
-
The New SchoolColumbia University; Universidad del Norte; HIASRecruitingMental Health Wellness 1Colombia
-
University of Wisconsin, MadisonCompletedMental Health Wellness 1United States
-
University of BathKing's College London; University of Pennsylvania; Newcastle University; University... and other collaboratorsCompletedMental Health Wellness 1United Kingdom
-
The University of Hong KongThe Boys' and Girls' Clubs Association of Hong KongCompleted
-
University of South WalesMIND CymruTerminated
Clinical Trials on Qigong
-
Florida International UniversityArizona State UniversityCompletedMental Health | Physical HealthUnited States
-
Tri-Service General HospitalCompletedCognitive Dysfunction | Exercise Training | Cognitive Decline | Cognitive Aging | Grip | Physical Endurance
-
Ching-I ChangTaipei Hospital, TaiwanCompletedQuality of Life | Breast Cancer | Intraoperative AwarenessTaiwan
-
Nova Scotia Health AuthorityCompletedChronic Pain
-
Radboud University Medical CenterUniversitas TarumanagaraCompletedDepressive Symptoms | Well-beingIndonesia
-
Akdeniz UniversityCompletedQuality of Life | Postoperative Pain | Muscle Weakness | Pain, Shoulder | Respiratory Function Loss | Joint AdhesionTurkey
-
University of HoustonBrigham and Women's Hospital; Texas Woman's UniversityActive, not recruitingQuality of Life | Physical Function | Caregiver DistressUnited States
-
Eman Mohamed othmanNot yet recruiting
-
Lund UniversityThe Swedish Institute for Health Sciences; Ekhaga foundation; Greta and Johan...CompletedLumbar Disc Herniation | Lumbago | Chronic Low Back Pain | Lumbar Spinal Stenosis | Lumbar Spondylolisthesis | Lumbar Disc Degeneration | Chronic Sciatica | Persistent Postoperative PainSweden
-
Dartmouth-Hitchcock Medical CenterCompletedFalls, Balance Self-confidenceUnited States