NCT06046911

Brief Summary

The goal of this intervention study was to test balance ability and quality of life in older adults with gait problems. The main questions it aims to answer are: 1. Can the balance ability of elderly people with gait disorders be improved through Tai Chi intervention? 2. Whether Tai Chi intervention can improve the quality of life of elderly people with gait disorders. Participants will be divided into an experimental group and a control group. The experimental group will undergo 12 weeks of Tai Chi intervention, while the control group will maintain daily habits, including simple walking or stretching activities.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

23 days

First QC Date

September 11, 2023

Last Update Submit

September 18, 2023

Conditions

Keywords

Tai ChiBalanceGaitQuality of lifeMuscle strength

Outcome Measures

Primary Outcomes (8)

  • Effects of 12 weeks of Tai Chi intervention on balance ability in the elderly

    The main test method is the single-leg eyes-closed test

    The balance ability of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks

  • Effects of 12 weeks of Tai Chi intervention on gait speed of the elderly

    Gait speed measurement mainly uses the four-meter walking test

    The gait speed of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks

  • Effects of 12 weeks of Tai Chi intervention on gait skills

    Gait skill measurement mainly uses the figure-8 walking test

    The gait skills of the elderly were tested before the intervention and at 6 and 12 weeks after the intervention

  • Effects of 12-week Tai Chi intervention on mobility of the elderly

    Time Up and Go measures mobility

    The Mobility of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks

  • Effects of 12 weeks of Tai Chi intervention on upper limb muscle strength in the elderly

    Grip strength test upper limb muscle strength

    The upper limb muscle strength of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks

  • Effects of 12 weeks of Tai Chi intervention on lower limb muscle strength in the elderly

    30s chair test to measure lower limb muscle strength

    The lower limb muscle strength of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks

  • Effect of 12-week Tai Chi intervention on fall risk in the elderly

    Time Up and Go measures Fall risk

    The Fall risk of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks

  • Effects of 12-week Tai Chi intervention on the quality of life of the elderly

    Measured using Questionnaire, 36-Item Short Form Surve (SF-36) Scale

    The Quality of life of the elderly was tested before the intervention, after 6 weeks of intervention, and at 12 weeks

Study Arms (2)

Tai Chi group

EXPERIMENTAL

The intervention was 12 weeks of Yang-style Tai Chi, three times a week.

Other: Tai Chi

Daily activity group

EXPERIMENTAL

The daily activity group mainly maintained daily activities, such as walking and stretching, three times a week for 12 weeks.

Other: Daily activity group

Interventions

Tai ChiOTHER

In this study, Tai Chi has a total of 24 movements, which are connected step by step according to the principles of sports training.

Tai Chi group

The daily activity group does not receive special intervention, and the subjects must maintain their daily habits and complete the 12-week test.

Daily activity group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years old Have mild gait problems Can walk independently No Tai Chi training experience or exercise habits

You may not qualify if:

  • Age \<60 years old No obvious problems with gait walking with tools Have experience in Tai Chi intervention within three months hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binhe Sports Center

Taiyuan, Shanxi, 030000, China

RECRUITING

Related Publications (8)

  • Borowicz A, Zasadzka E, Gaczkowska A, Gawlowska O, Pawlaczyk M. Assessing gait and balance impairment in elderly residents of nursing homes. J Phys Ther Sci. 2016 Sep;28(9):2486-2490. doi: 10.1589/jpts.28.2486. Epub 2016 Sep 29.

    PMID: 27799676BACKGROUND
  • Chang JH, Koo M, Wu SW, Chen CY. Effects of a 12-week program of Tai Chi exercise on the kidney disease quality of life and physical functioning of patients with end-stage renal disease on hemodialysis. Complement Ther Med. 2017 Feb;30:79-83. doi: 10.1016/j.ctim.2016.12.002. Epub 2016 Dec 7.

    PMID: 28137531BACKGROUND
  • Taylor-Piliae RE, Haskell WL, Waters CM, Froelicher ES. Change in perceived psychosocial status following a 12-week Tai Chi exercise programme. J Adv Nurs. 2006 May;54(3):313-29. doi: 10.1111/j.1365-2648.2006.03809.x.

    PMID: 16629916BACKGROUND
  • Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14.

    PMID: 20947672BACKGROUND
  • Ke XH, Huang DB, Li YY, Li XM, Guo JH, Guo MM, Yu SX, Ma SC, Jiang C, Lin ZH. Effects of 12 weeks of Tai Chi Chuan intervention on the postural stability and self-reported instability in subjects with functional ankle instability: Study protocol for a randomized controlled trial. Front Neurol. 2022 Sep 21;13:923669. doi: 10.3389/fneur.2022.923669. eCollection 2022.

    PMID: 36212637BACKGROUND
  • Perez-Cruzado D, Gonzalez-Sanchez M, Cuesta-Vargas AI. Parameterization and reliability of single-leg balance test assessed with inertial sensors in stroke survivors: a cross-sectional study. Biomed Eng Online. 2014 Aug 30;13:127. doi: 10.1186/1475-925X-13-127.

    PMID: 25174611BACKGROUND
  • Soke F, Demirkaya S, Gulsen C, Yavuz N, Karakoc S, Ozcan Gulsen E, Yilmaz O, Kocer B, Kurtulus Aydin F, Yucesan C. The figure-of-eight walk test is a reliable and valid test for assessing walking skill in people with multiple sclerosis. Mult Scler Relat Disord. 2022 Nov;67:104099. doi: 10.1016/j.msard.2022.104099. Epub 2022 Aug 9.

    PMID: 35969935BACKGROUND
  • Taylor-Piliae RE, Hoke TM, Hepworth JT, Latt LD, Najafi B, Coull BM. Effect of Tai Chi on physical function, fall rates and quality of life among older stroke survivors. Arch Phys Med Rehabil. 2014 May;95(5):816-24. doi: 10.1016/j.apmr.2014.01.001. Epub 2014 Jan 17.

    PMID: 24440643BACKGROUND

Related Links

MeSH Terms

Conditions

Mobility Limitation

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Fan Xu

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: In this experiment, the experimental group will practice Yang Style Tai Chi.The control group will be the daily activity group, maintaining daily activities such as walking. There are males and females in each parallel group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 21, 2023

Study Start

September 8, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations