Effects of a Biomechanical-based Tai Chi Program on Gait and Posture in People With Parkinson's Disease

NCT04644367 | Completed DMC

• 1 other identifier: H-01-19-2284
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) is associated with changes in gait and posture that can lead to a higher frequency of falls and injuries in this population. Research has shown a positive effect of tai chi (TC) training on the movement capacity for those with PD, however the understanding of the impact of TC training on gait and postural stability in PD is lacking. This study aims to examine the impact of a biomechanical-based TC intervention on dynamic postural stability and how it relates to walking performance. It is hypothesized that the effects of the TC intervention will help to improve measures relating to postural stability, gait, and cognition.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Gait; postural stability; falls; Tai Chi

Outcome Measures

Primary Outcomes (2)

• Change in Center of Mass-Center of Pressure (COM-COP) Separation Distance

  The COM-COP separation distance will be determined from the 3D-motion capture data. The participants will be asked to walk at a self-selected/comfortable pace and to crossover a 20-centimeter-high obstacle placed in the middle of the walkway (5 trials; averaged reported in meters).

  baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

• Change in Clearance Distance Height

  The clearance distance of the toe and heel will be determined from the 3D-motion capture data. The participants will be asked to walk at a self-selected/comfortable pace and to crossover a 20-centimeter-high obstacle placed in the middle of the walkway (5 trials; averaged reported in centimeters). This distance will be determined by the marker position of the heel/toe away from the top of the obstacle.

  baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

Secondary Outcomes (9)

• Montreal Cognitive Assessment (MoCA)

  baseline

• Change in Balance, Lower-limb Muscle Strength

  baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

• Change in Mobility

  baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

• Change in Mental Flexibility

  baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

• Change in Processing Speed

  baseline, 6 weeks (mid-intervention), and 12 weeks (post-intervention)

Study Arms (2)

Tai Chi group

EXPERIMENTAL

The Tai Chi (TC) group will receive or be taught TC in a class size consisting of about 5-12 students. Classes will be taught by a TC master with more than 4 years of experience practicing either Yang or Wu style TC. The participants will be allowed to practice TC at home and during their leisure time so long as they keep an activity log of their daily TC practice. This monitoring form (i.e. activity log or journal) will be distributed to all members of this group and collected weekly.

Other: Tai Chi intervention

Regular Physical Activity (control) group

ACTIVE COMPARATOR

The regular physical activity (control) group will be asked to maintain or engage in at least 60 minutes of regular physical activity on their own for three times per week. The participants will be instructed as to the type of regular PA that they may engage in. These types of PA include: walking, cleaning or performing chores inside the home, and/or climbing the stairs. No restriction will be made to limit others forms of physical activity; individuals in the control group will be permitted to engage in organized sports, instructor-led class such as boxing, dance, etc. to ensure the participant recruitment process is feasible. Similar to the TC group, participants in this group will be asked to complete an activity log (or journal) that will be collected weekly to monitor their regular PA levels.

Other: Regular Physical Activity (control) group

Interventions

Tai Chi intervention OTHER

TC classes will be 60 minutes long, offered three times per week over a 12-week period. The participants who receive the TC intervention will be encouraged to attend at minimum two of the three sessions offered per week. The TC classes will follow the same order that will begin with a 5 to 10 minutes warm up, 40 minutes of core activities, and 5 minutes of cool-down. The training intensity and difficulty level of the TC program will gradually proceed from low, moderate, to advance. The classes will be offered in a group setting at a convenient location within a community centre or gymnasium. Alternatively, classes will be offered outdoors in the park or by the canal during the spring-summer months. Due to the COVID-19 situation, additional adaptive measures will be taken using online social platforms such as ZOOM or Hangout to deliver the classes.

Tai Chi group

Regular Physical Activity (control) group OTHER

Regular Physical Activity group who will not be receiving the TC intervention

Regular Physical Activity (control) group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been diagnosed with PD and demonstrate a disease severity ranging from 1 to 3 on the Hoehn and Yahr (H\&Y) scale
• Have no fluctuations in motor symptoms as reported by the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)
• Have stable PD (such as levodopa or carbidopa) and doctor-prescribed medication use, that is, fluctuation did not occur at the time of medication intake;
• Can stand and walk independently
• Availability: three times per week over a period of 12 weeks
• Be able to engage in PA for at least 60 min on their own, thrice per week, without prior experience practicing TC regularly.

You may not qualify if:

• Enrolled into any other behavioral or pharmacological studies
• Have a Montreal Cognitive Assessment (MoCA) score of \< 26/27 (that indicate some mild cognitive impairment (MCI))
• Have had a serious medical condition or uncontrolled hypertension (equal or greater than a systolic 180 or diastolic 110 reading)
• Have any debilitating conditions that could prevent them from performing any PA for a minimum of 60 minutes.
• Have practiced or have experience of practicing TC in an organized class or program within the last 5 years at the start of participation in the study.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

Human Movement Biomechanics Laboratory

Ottawa, Canada

Location

Related Publications (3)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Law NY, Li JX, Zhu Q, Nantel J. Effects of a biomechanical-based Tai Chi program on gait and posture in people with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2023 Jun 30;24(1):241. doi: 10.1186/s13063-023-07146-x.

  PMID: 37386473 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principle investigator, co-investigators will analyze and interpret the data, but will be blinded to the group allocation (single-blind). The principle investigator, co-investigators will restrict discussion of the study's outcomes with the research assistants who will be aware allocation, and who will be involved in data entry or collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A prospective, single-blind, randomized control trial of 40 individuals with early-stage PD (Hoehn \& Yahr stages 1 to 3).

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: October 31, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)