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

NCT ID: NCT07297368

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease (PD)

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Usual Treatment (Standard Clinical Care)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie Whitney, MSc

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Locations

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King's College Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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24/WS/0099

Identifier Type: -

Identifier Source: org_study_id