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

NCT07297368 | Active Not Recruiting

• 1 other identifier: 24/WS/0099
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson's disease; Tai Chi; Enhanced Tai Chi; Qigong; Mind-body exercise; Non-pharmacological intervention; Balance training; Falls prevention; Motor symptoms; Non-motor symptoms; Quality of life; Pilot study; Feasibility study; Remote intervention; Hybrid trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in non-motor symptoms (MDS Non-Motor Symptoms Scale)

  Baseline, 12 weeks, and 3-month follow-up

• Patient Global Impression of Change (PGIC)

  12 weeks and 3-month follow-up

• Change in quality of life (PDQ-8)

  Baseline, 12 weeks, and 3-month follow-up

• Change in cognitive function (MoCA)

  Baseline, 12 weeks, and 3-month follow-up

• Change in pain (King's Parkinson's Disease Pain Scale - KPPS)

  Baseline, 12 weeks, and 3-month follow-up

Study Arms (2)

Enhanced Tai Chi + Usual Treatment

EXPERIMENTAL

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)

Usual Treatment (Control)

ACTIVE COMPARATOR

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)

Interventions

Usual Treatment (Standard Clinical Care) OTHER

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.

Usual Treatment (Control)

Enhanced Tai Chi (Enhanced-Tai-Chi-PD) BEHAVIORAL

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.

Enhanced Tai Chi + Usual Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SW9 8RR, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Julie Whitney, MSc

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: May 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Post publication of data (earliest 01-DEC-2026)

Locations

GB (1)