Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001250628
Ethics application status
Approved
Date submitted
26/06/2023
Date registered
1/12/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
1/12/2023
Date results provided
1/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of chronic Tai Chi Chuan and aerobic exercise interventions on motor and neurocognitive performance in early-stage Parkinson’s disease
Scientific title
Effects of chronic Tai Chi Chuan and aerobic exercise interventions on motor and neurocognitive performance in early-stage Parkinson’s disease
Secondary ID [1] 309974 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson’s disease 330460 0
Condition category
Condition code
Neurological 327313 327313 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 12-week aerobic exercise program consisted of a 30 min training session performed three times weekly on a recumbent stationary bicycle. Before every training session, each participant’s resting heart rate was measured to calculate their heart rate reserve (HRR). The aerobic exercise protocol included a 4 min warm-up phase, followed by 24 min of moderate-to-high-intensity interval aerobic training (eight cycles of 1 min with 70–75% HRR followed by a 2 min active recovery period [target RPE: 9–11]), and finally a 2 min cool-down period. The target HR was monitored using a Polar HR monitor (RS800CX, Polar Electro Oy, Kempele, Finland). The participants were verbally encouraged to achieve the appropriate intensity for each phase, and they exercised under the medical supervision of a physical therapist.

The 12-week Tai Chi Chuan program comprised two 60 min sessions per week, and each session was led by a Tai Chi Chuan master with over 20 years of experience. The session consisted of a warm-up and the main exercise, and all movements were adapted from the Yang-style short form. The warm-up session included the bear swing, the Tai Chi walk, and a range of motion exercises. It focused on kinesthetic awareness, mind–body preparation, and stretching and incorporated high-amplitude and diagonal movements. The main exercise phase focused on weight-shifting skills; bilateral coordination; and postural control, including preparation, beginning, roll back, ward off, push, press, and single whip elements. The Tai Chi master first demonstrated a movement, then deconstructed it and taught it step by step. To ensure accuracy, the master corrected each participant’s movements. One to two new movements were taught in each session, and the entire sequence of learned postures was practiced together to reinforce the connection between the mental tracking and the physical aspect. In addition to the postures, the participants were taught other essential elements of Tai Chi Chuan, such as body orientation, breathing, and relaxation.

1. The aerobic exercise will be run individually and the Tai Chi Chuan will be a group class with the ratio of 1:5~1:10 (5~10 participants with 1 leader)
2. Each participant will only attend in one group.
3. Attendance record will be done in each intervention to monitor the adherence.

Each participant will only attend in one group, one program.
Intervention code [1] 326384 0
Rehabilitation
Comparator / control treatment
The participants assigned to the control group maintained their normal daily physical activity patterns during the 12-week period. They were asked to maintain an activity log. This log was examined by investigators to ensure that there was no bias due to lifestyle changes during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 335840 0
N2 event-related potential (ERP) difference waveform latency recorded on electroencephalography (EEG) while conducting the S1-S2 working memorytest
Timepoint [1] 335840 0
Baseline and after 12 week-intervention
Primary outcome [2] 335841 0
P3 event-related potential (ERP) difference waveform latency recorded on electroencephalography (EEG) while conducting the S1-S2 working memorytest
Timepoint [2] 335841 0
Baseline and after 12 week-intervention
Primary outcome [3] 335842 0
Neuropsychological (i.e., reaction time and accuracy rate) of the S1-S2 working memorytest
Timepoint [3] 335842 0
Baseline and after 12 week-intervention
Secondary outcome [1] 423390 0
Unified Parkinson’s disease rating scale part iii motor sub scale score
Timepoint [1] 423390 0
Baseline and after 12 week-intervention

Eligibility
Key inclusion criteria
The clinical inclusion criteria were as follows: (a) a confirmed diagnosis of PD by neurologists at the Neurology Department of one of the above hospitals, and a medically stable status; (b) a modified Hoehn & Yahr score between 1 and 2, indicating early-stage PD; (c) the absence of any major comorbidities, such as dementia or depression; (d) no brain abnormalities (e.g., stroke or malignant brain tumor) on structural MRI scans; (e) age between 50 and 80 years; (f) confirmed ability to complete exercise training, as determined using the Physical Activity Readiness Questionnaire (PAR-Q) and by their treating neurologist; and (g) willingness to be randomly assigned to one of the exercise intervention groups or the control group.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were as follows: (a) a history of any neurological disease other than PD; (b) a diagnosis of dementia based on a MMSE or Montreal Cognitive Assessment (MoCA) score of < 24; (c) moderate or significant depression, as assessed based on a score of > 16 for the Beck Depression Inventory-II (BDI-II); (d) use of medication that interferes with cognition, alertness, or attention; or (e) previous or current participation in an exercise training program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using procedure like lots drawing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The minimum required sample size was subjected to an a priori power analysis using the G*Power software . Since no previous studies had simultaneously examined the longitudinal effects of Tai Chi Chuan and aerobic exercise on both motor and neurocognitive function in PD patients, we referred to Tsai et al. [53] to calculate the applicable effect-size value. That study examined the effect of chronic exercise on neurocognitive indices in people with neurodegenerative diseases, using two exercise groups and a control group. The type of statistical test was set to "ANOVA: Repeated Measures, Within–between Interaction," and the test family was set to "F-tests." Three intervention modes with two repetitions (for the three groups [aerobic exercise, Tai Chi Chuan, and control] × two time periods [pre-intervention vs. post-intervention]) were selected. The power level was set to at least 0.95, and the type I error probability was set at 0.05. The effect size was set to 0.20. The total sample size required was estimated as 21, meaning that a minimum of 21 people were needed to achieve a power level of 0.9717

One-way analyses of variance (ANOVAs) were used to assess group differences in pre- and post-intervention demographic characteristics and clinical assessment scores. The sexual variable was conducted using Pearson’s chi-squared test . The neuropsychological indices (ARs and RTs) were subjected to a 3 (groups:AE,TE,and CG)×2 (time: pre- and post-intervention)×2 (condition:congruent and incongruent) mixed-model repeated measures ANOVA (RM-ANOVA). A 3 (groups:AE,TE,and CG)×2 (time: pre- and post-intervention)×3 (electrode sites:Fz,Cz,and Pz)×2 (condition:congruent and incongruent) mixed-model RM-ANOVA was applied to the neurophysiological indices (N2 and P3 latencies and amplitudes). When a significant main effect was found, we performed Bonferroni post hoc tests to determine the specific difference. The Greenhouse–Geisser correction was applied when the sphericity assumption was not fulfilled. The Kolmogorov–Smirnov and Levene's tests were used to test the data for normality and homogeneity, respectively. To complement the significance testing, we calculated the partial eta-squared (?2p) to estimate the effect size of the group differences. A significance level of a = .05 was used; in other words, p values of < 0.05 were considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/01/2020
Date of last participant enrolment
Anticipated
Actual
20/12/2022
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
51
Accrual to date
Final
43
Recruitment outside Australia
Country [1] 25609 0
Taiwan, Province Of China
State/province [1] 25609 0

Funding & Sponsors
Funding source category [1] 314148 0
Government body
Name [1] 314148 0
National Science and Technology Council
Country [1] 314148 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
National Science and Technology Council
Address
National Science and Technology Council, 106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 316067 0
None
Name [1] 316067 0
Address [1] 316067 0
Country [1] 316067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313283 0
Human Research Ethics Center of National Cheng Kung University
Ethics committee address [1] 313283 0
Ethics committee country [1] 313283 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 313283 0
01/08/2022
Approval date [1] 313283 0
06/09/2022
Ethics approval number [1] 313283 0
111-394
Ethics committee name [2] 313454 0
CHANG GUNG MEDICAL FOUNDATION INSTITUTIONAL REVIEW BOARD
Ethics committee address [2] 313454 0
Ethics committee country [2] 313454 0
Taiwan, Province Of China
Date submitted for ethics approval [2] 313454 0
01/08/2019
Approval date [2] 313454 0
23/10/2019
Ethics approval number [2] 313454 0
201901361A3C504

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127594 0
Prof Chia, Liang, Tsai
Address 127594 0
Institute of Physical Education, Health and Leisure Studies, National Cheng Kung University, No.1, University Road, Tainan City 701, Taiwan
Country 127594 0
Taiwan, Province Of China
Phone 127594 0
+886 6 2757575
Fax 127594 0
Email 127594 0
[email protected]
Contact person for public queries
Name 127595 0
Chia, Liang, Tsai
Address 127595 0
Institute of Physical Education, Health and Leisure Studies, National Cheng Kung University, No.1, University Road, Tainan City 701, Taiwan
Country 127595 0
Taiwan, Province Of China
Phone 127595 0
+886 6 2757575
Fax 127595 0
Email 127595 0
[email protected]
Contact person for scientific queries
Name 127596 0
Chia, Liang, Tsai
Address 127596 0
Institute of Physical Education, Health and Leisure Studies, National Cheng Kung University, No.1, University Road, Tainan City 701, Taiwan
Country 127596 0
Taiwan, Province Of China
Phone 127596 0
+886 6 2757575
Fax 127596 0
Email 127596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no IPD sharing due to the privacy concerned.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.