Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT07297368
Brief Summary:
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.
Enhanced 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.
This 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.
The primary outcomes are:
* Change in motor symptoms measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III).
* Feasibility, assessed by adherence to scheduled sessions.
Secondary 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.
Adverse 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.
If 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.
Detailed Description:
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.
Tai 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).
Enhanced 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.
Study Objectives
Primary objectives
1. Assess the effect of Enhanced Tai Chi on motor symptoms using MDS-UPDRS Part III (motor examination).
2. Evaluate feasibility through adherence and tolerance to the intervention.
Secondary objectives
1. Assess effects on non-motor symptoms, falls, balance, walking speed, fatigue, pain, mood, anxiety/depression, cognition, sleep, physical activity and quality of life.
2. Compare feasibility against other exercise-based interventions such as ballet.
Study Design
* Single-site, randomised, controlled interventional pilot trial.
* 30 adults with idiopathic PD will be assigned as follows:
* Intervention arm (n = 20): Enhanced Tai Chi + usual clinical care
* Control arm (n = 10): Usual clinical care alone
* Randomisation ratio = 2:1
Intervention
\- Intervention participants attend: 36 one-hour Tai Chi sessions over 12 weeks
1. in-person session per week
2. remote sessions via Microsoft Teams Independent short daily practice (optional but encouraged)
Programme consists of seven tailored components:
* Ancient Shaolin Qi Gong
* Single hand silk-reeling
* Double hand silk-reeling
* Standing Qi posture / energy exercises
* Balance walking
* Fa Jin (energy release)
* Ten-direction balance form
Each session also includes optional social time and peer interaction.
Control Group Participants remain on their usual treatment pathway (medications, referrals for physiotherapy or other therapies when clinically indicated).
Assessments
1. Outcome measures recorded at baseline, post-intervention (12 weeks) and follow-up (3 months):
2. Motor symptoms: MDS-UPDRS Part III
3. Non-motor symptoms: MDS-NMS
4. Balance and gait: Berg Balance Scale, Timed Up and Go, 10-Meter Walk Test
5. Cognitive function: Montreal Cognitive Assessment (MoCA)
6. Pain: King's PD Pain Scale
7. Fatigue: PFS-16
8. Sleep: PDSS-2
9. Quality of life: PDQ-8, EQ-5D-5L
10. Mood and mental health: HADS, Apathy Scale
11. Falls: weekly fall diaries
12. Patient Global Impression of Change (PGIC)
Eligibility 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
Exclusion 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
Ethics 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
Data Handling Data pseudonymised Stored securely on password-protected and restricted-access servers
Expected Outcomes and Impact
This project will determine:
* Whether Enhanced Tai Chi improves motor and non-motor outcomes
* Whether the programme is feasible and acceptable for people with PD
* Effect sizes needed to power a future full-scale randomised controlled trial
If 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.
Study:
NCT07297368
Study Brief:
Protocol Section:
NCT07297368