Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT07297368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Tai-Chi-PD v1.0
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Baseline and Outcome assessments are performed by a blinded rater who is not involved in intervention delivery and does not have access to group allocation. Participants and care providers are not masked due to the nature of the behavioural intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized in a 2:1 ratio to either the Enhanced Tai Chi intervention group (Enhanced-Tai-Chi-PD + usual treatment) or the control group (usual treatment only). The intervention group receives 36 sessions over 12 weeks (one in-person session and two remote sessions per week via Microsoft Teams). The control group continues with usual clinical care per local pathway. No crossover occurs between groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in motor symptoms (MDS-Unified Parkinson's Disease Rating Scale, Part III)", 'timeFrame': 'Baseline to 12 weeks (end of intervention)', 'description': "MDS-UPDRS Part III assesses motor function in Parkinson's disease (motor examination performed during the ON medication state). Scores range from 0-132, with higher scores indicating more severe motor impairment."}], 'secondaryOutcomes': [{'measure': 'Change in non-motor symptoms (MDS Non-Motor Symptoms Scale)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Assesses frequency and severity of non-motor symptoms. Higher scores indicate greater symptom burden.'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': '12 weeks, 3-month follow-up', 'description': 'Participant-reported overall perception of change in health status.'}, {'measure': 'Change in quality of life (PDQ-8)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': "Parkinson's Disease Questionnaire-8 item. Lower scores indicate better quality of life."}, {'measure': 'Change in cognitive function (MoCA)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Montreal Cognitive Assessment, 0-30 scale; higher scores indicate better cognition.'}, {'measure': "Change in pain (King's Parkinson's Disease Pain Scale - KPPS)", 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': "Assesses Parkinson's-related pain severity across multiple domains."}, {'measure': 'Change in sleep disturbance (PDSS-2)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': "Parkinson's Disease Sleep Scale-2; higher scores indicate worse sleep quality."}, {'measure': 'Change in fatigue (PFS-16)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Parkinson Fatigue Scale; higher scores indicate more fatigue.'}, {'measure': 'Change in anxiety and depression (Hospital Anxiety and Depression Scale - HADS)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Assesses anxiety and depressive symptoms (subscales scored independently).'}, {'measure': 'Change in apathy (Apathy Scale - AS)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Assesses apathy'}, {'measure': 'Change in physical activity level (PASE)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Assesses participant reported physical activity level'}, {'measure': 'Change in global clinical severity (CISI-PD)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Clinician reported severity change'}, {'measure': 'Change in balance performance (Berg Balance Scale)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': '14-item balance assessment; higher scores = better balance.'}, {'measure': 'Change in mobility (Timed Up and Go - TUG)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Time in seconds to stand, walk 3 meters, turn, return, and sit.'}, {'measure': 'Change in walking speed (10-Meter Walk Test)', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': '10-meter times walk'}, {'measure': 'Number of monthly falls', 'timeFrame': 'Baseline, 12 weeks, 3-month follow-up', 'description': 'Participants maintain fall diaries.'}, {'measure': 'Feasibility / compliance with intervention', 'timeFrame': 'Continuous over 12-week intervention', 'description': 'Measured by % of scheduled Tai Chi sessions attended; withdrawal rate and tolerability also recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tai chi', 'enhanced tai chi', 'Qigong', 'mind-body exercise', 'non-pharmacological intervention', 'complementary therapy', 'motor control training', 'motor symptoms', 'nonmotor symptoms', 'balance', 'falls prevention', 'quality of life', 'fatigue', 'anxiety', 'depression', 'physical activity', 'randomised controlled trial', 'pilot study', 'feasibility study', 'remote intervention', 'hybrid trial'], 'conditions': ['PARKINSON DISEASE (Disorder)', 'Parkinson s Disease', 'Parkinson Disease', 'Parkinson Desease', 'Parkinson Disease (PD)']}, 'descriptionModule': {'briefSummary': "This study investigates whether a specialised form of Tai Chi can improve motor and non-motor symptoms in people with Parkinson's disease (PD). Parkinson's disease affects movement, balance, gait, and posture, but also causes symptoms such as fatigue, anxiety, low mood, cognitive changes, sleep disturbances and pain. While medication improves some symptoms, balance and postural stability often do not respond fully, increasing fall risk and loss of independence. Many people with PD are interested in complementary approaches such as Tai Chi, but high-quality clinical trials are limited.\n\nEnhanced Tai Chi is a structured programme developed specifically for people with Parkinson's by Shifu Yang, a Tai Chi and Qi Gong master. This adapted version includes seven movement components (Qi Gong, silk-reeling, balance walking, energy release and postural alignment techniques) designed to improve balance control, gait, coordination, body awareness, and confidence in movement.\n\nThis proof-of-concept pilot study will enrol 30 participants with idiopathic Parkinson's disease (Hoehn \\& Yahr stage I-III). Participants will be randomised in a 2:1 ratio to the intervention group or control group. All participants continue their usual clinical care. The intervention group completes 36 supervised Tai Chi sessions over 12 weeks (3 sessions/week: one studio-based and two remote via Microsoft Teams) plus optional daily independent practice. Compliance will be recorded using online session attendance.\n\nThe primary outcomes are:\n\n* Change in motor symptoms measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III).\n* Feasibility, assessed by adherence to scheduled sessions.\n\nSecondary outcomes include quality of life, non-motor symptoms, pain, fatigue, sleep quality, balance, walking tests, anxiety/depression, cognitive function, and number of falls. Validated questionnaires and clinical tests (e.g., Berg Balance Scale, Timed Up and Go, 10-Meter Walk Test) will be performed at baseline, end of intervention (12 weeks), and 3-month follow-up.\n\nAdverse events and medication changes will be monitored throughout the study. Data will be pseudonymised and stored securely according to GDPR and Good Clinical Practice standards.\n\nIf effective, this pilot trial will support the design of a future large-scale randomised controlled trial and may provide evidence for Enhanced Tai Chi as a scalable, low-risk, non-pharmacological therapy for improving motor function, balance, and quality of life in people with Parkinson's disease.", 'detailedDescription': "Background and Rationale Parkinson's disease (PD) is a progressive neurological condition characterised by motor symptoms-tremor, rigidity, slowness of movement (bradykinesia), and impaired balance-as well as non-motor symptoms such as anxiety, depression, cognitive difficulties, fatigue, pain and disturbed sleep. The prevalence of PD is increasing, and no current treatment has been shown to halt or slow disease progression. Exercise is recognised as an important non-pharmacological strategy that may improve physical function and quality of life and could have neuroprotective effects.\n\nTai Chi and Qigong are traditional mind-body practices involving slow, coordinated movements requiring postural control, weight shifting, breathing and mental focus. They have demonstrated benefits in balance, fall reduction, mood and well-being in older adults and people living with chronic conditions. Research suggests Tai Chi may improve balance and reduce falls in people with Parkinson's, but studies vary in quality and few provide detailed descriptions of movement content. To address this gap, this study evaluates a tailored programme-Enhanced Tai Chi for Parkinson's (Enhanced-Tai-Chi-PD).\n\nEnhanced Tai Chi was developed by master instructor Shifu Yang, based on Tai Chi, Qi Gong, Kung Fu and concepts from traditional Chinese medicine, modified specifically for challenges related to Parkinson's disease. The programme focuses on balance control, proprioception, coordination, body alignment and confidence in movement.\n\nStudy Objectives\n\nPrimary objectives\n\n1. Assess the effect of Enhanced Tai Chi on motor symptoms using MDS-UPDRS Part III (motor examination).\n2. Evaluate feasibility through adherence and tolerance to the intervention.\n\nSecondary objectives\n\n1. Assess effects on non-motor symptoms, falls, balance, walking speed, fatigue, pain, mood, anxiety/depression, cognition, sleep, physical activity and quality of life.\n2. Compare feasibility against other exercise-based interventions such as ballet.\n\nStudy Design\n\n* Single-site, randomised, controlled interventional pilot trial.\n* 30 adults with idiopathic PD will be assigned as follows:\n* Intervention arm (n = 20): Enhanced Tai Chi + usual clinical care\n* Control arm (n = 10): Usual clinical care alone\n* Randomisation ratio = 2:1\n\nIntervention\n\n\\- Intervention participants attend: 36 one-hour Tai Chi sessions over 12 weeks\n\n1. in-person session per week\n2. remote sessions via Microsoft Teams Independent short daily practice (optional but encouraged)\n\nProgramme consists of seven tailored components:\n\n* Ancient Shaolin Qi Gong\n* Single hand silk-reeling\n* Double hand silk-reeling\n* Standing Qi posture / energy exercises\n* Balance walking\n* Fa Jin (energy release)\n* Ten-direction balance form\n\nEach session also includes optional social time and peer interaction.\n\nControl Group Participants remain on their usual treatment pathway (medications, referrals for physiotherapy or other therapies when clinically indicated).\n\nAssessments\n\n1. Outcome measures recorded at baseline, post-intervention (12 weeks) and follow-up (3 months):\n2. Motor symptoms: MDS-UPDRS Part III\n3. Non-motor symptoms: MDS-NMS\n4. Balance and gait: Berg Balance Scale, Timed Up and Go, 10-Meter Walk Test\n5. Cognitive function: Montreal Cognitive Assessment (MoCA)\n6. Pain: King's PD Pain Scale\n7. Fatigue: PFS-16\n8. Sleep: PDSS-2\n9. Quality of life: PDQ-8, EQ-5D-5L\n10. Mood and mental health: HADS, Apathy Scale\n11. Falls: weekly fall diaries\n12. Patient Global Impression of Change (PGIC)\n\nEligibility Inclusion criteria Idiopathic Parkinson's disease (Hoehn \\& Yahr stage I-III) Able to stand and participate in movement sessions Stable medication dose for ≥ 4 weeks before study entry\n\nExclusion criteria Atypical or secondary parkinsonism Advanced therapies (DBS, apomorphine infusion, jejunal levodopa) Dementia (MoCA ≤ 21) Other neurological or medical conditions limiting participation Inability to commit to scheduled sessions\n\nEthics and Safety Conducted in accordance with GCP, GDPR, and the Declaration of Helsinki Study reviewed and approved by NHS Research Ethics and KCH Research \\& Innovation governance Adverse and serious adverse events monitored continuously Participants may withdraw at any time without affecting clinical care\n\nData Handling Data pseudonymised Stored securely on password-protected and restricted-access servers\n\nExpected Outcomes and Impact\n\nThis project will determine:\n\n* Whether Enhanced Tai Chi improves motor and non-motor outcomes\n* Whether the programme is feasible and acceptable for people with PD\n* Effect sizes needed to power a future full-scale randomised controlled trial\n\nIf successful, Enhanced Tai Chi could become a low-risk, scalable, accessible therapy complementary to standard medical treatment, improving mobility, balance and quality of life in Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic Parkinson's disease (Hoehn \\& Yahr stage I-III)\n* Able to stand and participate in movement sessions\n* Stable medication dose for ≥ 4 weeks before study entry\n\nExclusion Criteria:\n\n* Atypical or secondary parkinsonism\n* Advanced therapies (DBS, apomorphine infusion, jejunal levodopa)\n* Dementia (MoCA ≤ 21)\n* Other neurological or medical conditions limiting participation\n* Inability to commit to scheduled sessions"}, 'identificationModule': {'nctId': 'NCT07297368', 'briefTitle': 'Enhanced Tai-Chi-PD v1.0', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': "Enhanced Tai-Chi: A Randomised, Controlled, Single-site Study on the Effects of Enhanced Tai-Chi Training on Motor and Non-motor Symptoms of Parkinson's Disease: a Pilot Study", 'orgStudyIdInfo': {'id': '24/WS/0099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced Tai Chi + Usual Treatment', 'description': 'Participants receive the Enhanced Tai Chi intervention in addition to usual clinical care. The intervention consists of 36 structured sessions over 12 weeks (one in-person session per week and two remote video sessions via Microsoft Teams). Participants are also encouraged to complete short home practice sessions, with attendance monitored via online log-in. Usual clinical care continues as directed by the treating physician.', 'interventionNames': ['Behavioral: Enhanced Tai Chi (Enhanced-Tai-Chi-PD)']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Treatment (Control)', 'description': 'Participants continue standard clinical care as determined by their treating physician (stable dopaminergic medications, and referrals to physiotherapy, occupational therapy, speech and language therapy as clinically needed). No Tai Chi is provided during the study period.'}], 'interventions': [{'name': 'Enhanced Tai Chi (Enhanced-Tai-Chi-PD)', 'type': 'BEHAVIORAL', 'description': "Participants assigned to this arm receive Enhanced Tai Chi, a structured mind-body exercise program adapted specifically for people with Parkinson's disease. The program consists of 36 one-hour sessions delivered over 12 weeks (3 sessions/week: 1 in-person studio session and 2 remote sessions via Microsoft Teams). The intervention incorporates seven movement components including Qi Gong, single and double silk-reeling, standing energy/postural work, balance walking, Fa Jin (energy release), and a ten-direction balance form. Sessions focus on balance, postural control, fluid movement, coordination, breathing, and body alignment. Participants are encouraged to complete short additional home practice, and session attendance is logged to monitor compliance.", 'armGroupLabels': ['Enhanced Tai Chi + Usual Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW9 8RR', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Julie Whitney, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}