Enhanced Tai Chi for Parkinson's Disease (Enhanced Tai Chi PD) (ETC-PD)

Enhanced Tai Chi: A Randomised, Controlled, Single-Site Study of the Effects of Enhanced Tai Chi Training on Motor and Non-Motor Symptoms of Parkinson's Disease: A Pilot Study

This pilot study evaluates whether a structured, Parkinson's disease-specific Tai Chi programme ("Enhanced Tai Chi") can improve motor and non-motor symptoms in people with Parkinson's disease (PD).

PD is a progressive neurological condition associated with motor impairments such as bradykinesia, rigidity, gait disturbance and postural instability, as well as non-motor symptoms including fatigue, pain, mood disturbance, sleep problems and cognitive changes. Although pharmacological treatments improve many motor symptoms, balance and postural control often respond poorly, contributing to falls and reduced independence.

Enhanced Tai Chi is a tailored programme developed specifically for people with PD, incorporating elements of Tai Chi and Qi Gong focused on balance control, coordination, postural alignment, body awareness and confidence in movement. This single-site, randomised, controlled pilot trial will enrol 30 adults with idiopathic PD (Hoehn & Yahr stages I-III), randomised in a 2:1 ratio to Enhanced Tai Chi plus usual clinical care or usual clinical care alone.

Participants in the intervention group will complete 36 supervised one-hour sessions over 12 weeks (three sessions per week: one in-person and two delivered remotely), with optional independent practice encouraged. Adherence will be monitored through attendance records. Outcomes will be assessed at baseline, post-intervention and 3-month follow-up. Findings will inform feasibility, acceptability and preliminary efficacy estimates to support the design of a future definitive randomised controlled trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease (PD)
• Intervention / Treatment: Behavioral: Enhanced Tai Chi (Enhanced-Tai-Chi-PD); Other: Usual Treatment (Standard Clinical Care)

Detailed Description

Background and Rationale

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterised by motor and non-motor symptoms that substantially affect quality of life and functional independence. While dopaminergic therapies remain the cornerstone of treatment, symptoms such as balance impairment and postural instability often respond incompletely, increasing the risk of falls and injury. Exercise-based interventions are increasingly recommended as adjunctive therapies in PD and may improve mobility, balance, non-motor symptoms and overall quality of life.

Tai Chi and related mind-body practices emphasise slow, controlled movements, weight shifting, postural control, breathing and mental focus. Previous studies suggest Tai Chi may improve balance and reduce falls in people with PD; however, many trials vary in methodological quality and provide limited detail regarding intervention content. Enhanced Tai Chi for Parkinson's (Enhanced-Tai-Chi-PD) was developed to address these limitations by providing a structured, PD-specific programme targeting balance, proprioception, coordination and movement confidence.

Study Design

This is a single-site, randomised, controlled, interventional pilot study. Thirty adults with idiopathic Parkinson's disease will be randomised in a 2:1 ratio to either Enhanced Tai Chi plus usual clinical care or usual clinical care alone. Assessments will be conducted at baseline, after completion of the 12-week intervention period, and at 3-month follow-up.

Intervention

Participants allocated to the intervention arm will attend three one-hour sessions per week for 12 weeks (36 sessions total), comprising one in-person session and two remotely delivered sessions via a secure video platform. The programme consists of seven structured movement components adapted for Parkinson's disease, including Qi Gong-based exercises, silk-reeling movements, balance walking, standing postural exercises and coordinated directional movement forms. Optional independent practice is encouraged. Attendance and adherence will be recorded throughout the intervention period.

Participants in the control arm will continue with usual clinical care as determined by their treating clinicians.

Safety, Data Handling and Oversight

Adverse events, serious adverse events and medication changes will be monitored throughout the study. Study data will be pseudonymised and stored securely in accordance with General Data Protection Regulation (GDPR) requirements and Good Clinical Practice. The study has received appropriate ethical and institutional approvals.

Expected Outcomes

This pilot trial will generate preliminary data on feasibility, adherence and effect size estimates for Enhanced Tai Chi in Parkinson's disease. Results will inform the design and power calculations of a future definitive randomised controlled trial evaluating this intervention as a scalable, low-risk adjunct to standard Parkinson's disease care.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW9 8RR
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Tai Chi + Usual Treatment; Participants receive the Enhanced Tai Chi intervention in addition to usual clinical care. Enhanced Tai Chi consists of 36 structured one-hour sessions delivered over 12 weeks (three sessions per week: one in-person session and two remote sessions via Microsoft Teams). Participants are encouraged to undertake short additional home practice. Attendance is recorded to monitor adherence. Usual clinical care continues as directed by the treating physician.	Behavioral: Enhanced Tai Chi (Enhanced-Tai-Chi-PD); 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.
Active Comparator: Usual Treatment (Control); 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.	Other: Usual Treatment (Standard Clinical Care); Participants continue standard clinical care for Parkinson's disease as determined by their treating physician. No Enhanced Tai Chi or other study-specific exercise intervention is provided during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in motor symptoms (MDS-UPDRS Part III)	Clinician-rated assessment using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part III (MDS-UPDRS III), performed in the ON medication state. Total score ranges from 0 to 132, with higher scores indicating greater motor impairment. Reductions in score indicate improvement in motor symptoms.	Baseline to 12 weeks (end of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in non-motor symptoms (MDS Non-Motor Symptoms Scale)	Assesses frequency and severity of non-motor symptoms in Parkinson's disease. Total score ranges from 0 to 360, with higher scores indicating greater non-motor symptom burden. Interpretation of scores is as follows: Mild (1-44 points), Moderate (45-78 points), Severe (79-112 points), and very severe (>112).	Baseline, 12 weeks, and 3-month follow-up
Patient Global Impression of Change (PGIC)	Participant-reported overall perception of change in health status. Scored on a 7-point Likert scale (1 = very much improved, 4 = no change, 7 = very much worse). Lower scores indicate perceived improvement, while higher scores indicate worsening.	12 weeks and 3-month follow-up
Change in quality of life (PDQ-8)	Self-reported measure of health-related quality of life. Total score ranges from 0 to 32, with lower scores indicating better quality of life. A decrease in score reflects improvement. For this study, a meaningful change is defined as a change of 5-7 points, indicating clinical significant impact to quality of life.	Baseline, 12 weeks, and 3-month follow-up
Change in cognitive function (MoCA)	Brief cognitive screening tool. Total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores 26-30 (normal), 18-25 (mild cognitive impairment), 10-17 (moderate cognitive impairment), and <10 (severe cognitive impairment). Increases in score suggest improvement or preservation of cognitive function.	Baseline, 12 weeks, and 3-month follow-up
Change in pain (King's Parkinson's Disease Pain Scale - KPPS)	Clinician-rated assessment of Parkinson's disease-related pain across multiple domains. Total score ranges from 0 to 168, with higher scores indicating greater pain severity. Lower scores represent improvement in pain symptoms. Interpretation for this study: score 0 (no pain), scores 17-34 (mild to moderate), 68-70 (moderate to severe). Minimal clinical important difference is measured by a change of 3 points to indicate meaningful change.	Baseline, 12 weeks, and 3-month follow-up
Change in sleep disturbance (PD Sleep Scale-2)	Assesses sleep disturbances in Parkinson's disease. Total score ranges from 0 to 60, with higher scores indicating worse sleep quality. For this study, meaningful change is defined as a decrease of at least 3.44 points for improvement or an increase of at least 2.07 points for worsening.	Baseline, 12 weeks, and 3-month follow-up
Change in fatigue (Parkinson's Fatigue Scale-16)	Self-reported fatigue severity scale. Total score ranges from 16 to 80, with higher scores indicating greater fatigue.	Baseline, 12 weeks, 3-month follow-up
Change in anxiety and depression (Hospital Anxiety and Depression Scale - HADS)	Self-reported assessment of anxiety and depression using two subscales (HADS-A and HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity. Scores 0-7 (normal), 8-10 (mild/borderline), 11-14 (moderate), and 15-21 (severe). Lower scores indicate improvement in anxiety and/or depressive symptoms. Meaningful change is defined as change of 2 points.	Baseline, 12 weeks, and 3-month follow-up
Change in apathy (Apathy Scale - AS)	Self-reported measure of apathy. Total score ranges from 0 to 42, with higher scores indicating greater apathy. PD patients with scores over 14 suggest clinically significant meaningful apathy. Lower scores represent improvement in motivational symptoms.	Baseline, 12 weeks, 3-month follow-up
Change in physical activity level (PASE)	Self-reported assessment of physical activity over the previous week. Scores typically range from 0 to >400, with higher scores indicating greater levels of physical activity. Increases in score indicate higher activity levels.	Baseline, 12 weeks, 3-month follow-up
Change in global clinical severity (CISI-PD)	Clinician-rated global assessment across four domains (motor signs, disability, cognitive status, and complications). Each domain is scored from 0 to 6, giving a total score range of 0 to 24, with higher scores indicating greater disease severity. A reduction in total score over time indicates clinical improvement.	Baseline, 12 weeks, 3-month follow-up
Change in balance performance (Berg Balance Scale)	Clinician-rated 14-item assessment of balance performance. Total score ranges from 0 to 56, with higher scores indicating better balance. For this study we consider 0-20 (wheelchair/ high fall risk), 21-40 (needing aids/ moderate risk), 41-56 (independent, low risk), with scores <45 indicating increased risk of falls for the PD population. Increases in score indicate improvement in balance ability.	Baseline, 12 weeks, 3-month follow-up
Change in mobility (Timed Up and Go - TUG)	Performance-based assessment measuring the time (in seconds) required to stand from a seated position, walk 3 meters, turn, return, and sit down. Lower times indicate better mobility and functional performance. For this study with PD patients our scoring is as follows: <12 seconds (good mobility), 12-14 seconds (differentiates PD fallers vs non-fallers, with higher end being riskier), >14 seconds (high risk for fall), >20 seconds (needs assistance for basic transfer), and >30 seconds (limited mobility, decreased independence).	Baseline, 12 weeks, 3-month follow-up
Change in walking speed (10-Meter Walk Test)	Performance-based assessment measuring the time (in seconds) to walk 10 meters at a comfortable pace. Lower times indicate faster walking speed and improved gait performance. For this study, there needs to be a minimum detectable change of approximately 0.18 m/s (comfortable) or 0.25 m/s (fast) to show real improvement, not just testing variation.	Baseline, 12 weeks, 3-month follow-up
Number of monthly falls	Self-reported number of falls recorded using participant-maintained fall diaries. Higher values indicate increased fall frequency, while reductions indicate improvement in fall risk.	Baseline, 12 weeks, 3-month follow-up
Feasibility / compliance with intervention	17a. Intervention adherence: Percentage of scheduled Enhanced Tai Chi sessions attended during the intervention period. Values range from 0% to 100%, with higher percentages indicating better adherence. 17b. Intervention tolerability: Proportion of participants who discontinue the intervention due to tolerability issues. Values range from 0 to 100%, with lower percentages indicating better tolerability.	Continuous over 12-week intervention

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Julie Whitney, MSc, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Estimated): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Tai Chi; Balance training; Parkinson's disease; Pilot study; Feasibility study; Qigong; Non-pharmacological intervention; Non-motor symptoms; Motor symptoms; Falls prevention; Remote intervention; Enhanced Tai Chi; Mind-body exercise; Hybrid trial
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 24/WS/0099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared upon reasonable request after publication of primary results. Data access request can be made by contacting our Research Data team for the study (kch-tr.taichi.inbox@nhs.net)
• IPD Sharing Time Frame: Post publication of data (earliest 01-DEC-2026)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No