Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-27 @ 6:53 AM
Study NCT ID:
NCT06952166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Psychological Benefits and Neurophysiological Mechanisms of Qigong in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064906', 'term': 'Qigong'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'The eight-item Patient Health Questionnaire'}, {'measure': 'Global cognitive function', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'Montreal Cognitive Assessment'}], 'secondaryOutcomes': [{'measure': 'Serum adiponectin', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'Collected and assayed through peripheral blood sample'}, {'measure': 'Serum BDNF', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'Collected and assayed through peripheral blood sample'}, {'measure': 'Salivary cortisol', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'Collected and assayed through saliva sample'}, {'measure': 'Attention', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'Attention Network Task'}, {'measure': 'Inhibitory control', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'Attention Network Task'}, {'measure': 'Working memory', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'N-back Task'}, {'measure': 'ERP N2 amplitude', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'ERP data recorded during Attention Network Task and N-back Task'}, {'measure': 'ERP P3 amplitude', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'ERP data recorded during Attention Network Task and N-back Task'}, {'measure': 'Hand grip strength', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'To be assessed with a Jamar handheld dynamometer'}, {'measure': 'Affect', 'timeFrame': 'Baseline and post-intervention (12 weeks after baseline)', 'description': 'Positive and Negative Affect Schedule'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Qigong']}, 'descriptionModule': {'briefSummary': 'One goal of the study is to evaluate the efficacy of qigong to alleviate depressive symptoms and enhance cognitive function in comparison to mindfulness-based intervention, physical exercise, and waitlist control. The other goal is to explore the changes in neurobiological markers that may explain the qigong-related effects on depressive symptoms and cognitive function. The main research questions are:\n\n* Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to alleviate depressive symptoms?\n* Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to enhance cognitive function?\n\nParticipants are older adults aged 60 or above. They were randomly assigned to qigong training, mindfulness training, physical exercise training, or wait-list which all last for 12 weeks. Their changes before and after the 12-week period in depressive symptoms, neurobiological markers, and cognitive functions are assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years or older;\n* With mild or severer levels of depressive symptoms as indicated by the Geriatric Depression Scale (GDS-8) scores of 5 or above, or Depression Anxiety and Stress Scale-21 (DASS-21) depression subscale scores of 4 or above\n* Self-identified as physically stable and without life-threatening diseases.\n* Be able to communicate in Cantonese or Mandarin.\n\nExclusion Criteria:\n\n* Have a history of practicing or receiving training of any form of mind-body or regular exercises (including tai chi, yoga, and qigong, or regular physical activity \\> 3 times/week) during the month prior to intervention\n* Have changed medications or the dose of medications prescribed for their health condition in the one month prior to study enrollment\n* Have severe cognitive or language impairment based on the assessment with Montreal Cognitive Assessment (MoCA)\n* Taking medication or undergoing electroconvulsive therapy, psychotherapy, or psychoeducation for a psychological or psychiatric condition\n* Unable to demonstrate satisfactory standing balance'}, 'identificationModule': {'nctId': 'NCT06952166', 'briefTitle': 'Understanding the Psychological Benefits and Neurophysiological Mechanisms of Qigong in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Understanding the Psychological Benefits and Neurophysiological Mechanisms of Qigong in Older Adults', 'orgStudyIdInfo': {'id': '15104721-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qigong (Baduanjin)', 'description': '12-week training of Baduanjin, with two sessions per week. Each session lasts for 60 min.', 'interventionNames': ['Behavioral: Qigong (Baduanjin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness-based intervention', 'description': '12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week. Each session lasts for 60 min.', 'interventionNames': ['Behavioral: Mindfulness-based intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical exercise', 'description': '12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week. Each session lasts for 60 min.', 'interventionNames': ['Behavioral: Physical exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Participants of the waitlist control group will not receive any training while the other three group are having their interventions. After the completion of the all assessments, the participants will receive the 12-week qigong training, same as the qigong group.'}], 'interventions': [{'name': 'Qigong (Baduanjin)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 24 sessions of Baduanjin training over 12 weeks (2 sessions per week). Each session will last for 60 minutes. Baduanjin consists of eight forms of gentle movements, and it takes about 10 to 15 minutes to complete a full cycle. Participants will learn to practice each form gradually over the first 12 sessions. In the remaining 12 sessions, the participants will go through all the movements 2-3 times, with guided practice on rhythmic breathing and mind regulation (attention to body and breathing) to be performed in coordination with the movements. The training will be delivered by an instructor after training by the project team.', 'armGroupLabels': ['Qigong (Baduanjin)']}, {'name': 'Mindfulness-based intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive mindfulness-based intervention with the same duration and frequency as qigong group. The intervention incorporates psychoeducation on mindfulness and stress management and group-based mindfulness practice about breathing, awareness of body sensations, thoughts, stretching, and walking. All the mindfulness practices are based on publicly accessible audio recordings. The training will be delivered by an instructor after training by the project team.', 'armGroupLabels': ['Mindfulness-based intervention']}, {'name': 'Physical exercise', 'type': 'BEHAVIORAL', 'description': 'Participants of the physical exercise group will receive training of a series of low-to-moderate intensity physical activities for the same duration and frequency as qigong group. The physical activities include stretching, flexibility exercise, balance exercise, and aerobic exercise. The training will be delivered by an instructor after training by the project team.', 'armGroupLabels': ['Physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'country': 'Hong Kong', 'contacts': [{'name': 'Hector Tsang', 'role': 'CONTACT', 'email': 'hector.tsang@polyu.edu.hk', 'phone': '27666750'}], 'facility': 'Hong Kong Polytechnic University, Department of Rehabilitation Sciences', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Hector Tsang', 'role': 'CONTACT', 'email': 'hector.tsang@polyu.edu.hk', 'phone': '27666750'}, {'name': 'Erin Lu', 'role': 'CONTACT', 'email': 'erin.lu@polyu.edu.hk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'TSANG Hector Wing-Hong', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}