NCT06380413

Brief Summary

Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers. Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria. Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 17, 2024

Last Update Submit

April 22, 2024

Conditions

Keywords

physical exercisetai chi chuanwalkingmuscle strengthphysical activity

Outcome Measures

Primary Outcomes (2)

  • Maximal dynamic strength

    The maximum dynamic muscle strength of knee extensors will be measured through the one-repetition maximal test (1RM) performed in an extension chair. The 1RM value is considered the greatest load that the participant could lift for one complete repetition (i.e., concentric and eccentric phase) following a predetermined cadence (i.e., approximately 2 s per phase) controlled by a digital app (Metronome). The 1RM of each participant is determined within five attempts, and at least 3 min of rest interval was given between trials. A new load was estimated using correction factors (Lombardi, 1989) for the subsequent trial when the participant could perform more than one complete repetition. The test is rescheduled if the value of 1RM is not determined between the five attempts. According to a previous study from our laboratory (Andrade et al. 2020), the range of motion is individualized for each participant and controlled by a range of motion custom-build device.

    Baseline (week 0) to post-training (week 13)

  • Functional test - 30-s Chair-stand test

    The 30-s Chair-Stand test is performed to measure the strength of the lower limbs. Participants are instructed to sit and stand up from a chair 43 cm high from the seat, without the aid of the upper limbs, as many times as possible during 30 s.

    Baseline (week 0) to post-training (week 13)

Secondary Outcomes (16)

  • Dynamic muscular endurance

    Baseline (week 0) to post-training (week 13)

  • Isometric handgrip strength

    Baseline (week 0) to post-training (week 13)

  • Isometric back-leg-chest strength

    Baseline (week 0) to post-training (week 13)

  • Functional tests - arm curl

    Baseline (week 0) to post-training (week 13)

  • Functional tests - 8-ft Up-and-Go

    Baseline (week 0) to post-training (week 13)

  • +11 more secondary outcomes

Other Outcomes (9)

  • Body mass

    Baseline (week 0)

  • Height

    Baseline (week 0)

  • Waist and hip circumferences

    Baseline (week 0)

  • +6 more other outcomes

Study Arms (2)

Tai Chi Chuan Plus Walking

EXPERIMENTAL

Tai Chi Chuan plus walking program twice a week

Other: Tai Chi Chuan Plus Walking

Walking

ACTIVE COMPARATOR

Walking program twice a week

Other: Walking

Interventions

Participants perform a 12-week program with two weekly sessions on non-consecutive days. The sessions last 75 min (5 min of warm-up, 45 min of Tai Chi Chuan (TCC), 20 min of walking, and 5 min of cool-down). The intervention occurs at the School of Physical Education, Federal University of Pelotas. The TCC section occurs in a mirrored dance studio, while walking occurs on an indoor sports court. The TCC sections are based on the simplified Yang 16-movement form. Over the 12 weeks, participants learn the fundamentals and basic principles of TCC and practice the 16 movements. In the walking sections, the intensity of the effort and recovery periods are controlled through the Rate of Perceived Exertion (RPE) using the Borg scale 6-20. Effort and recovery periods are on 13 and 11 RPE, respectively. The effort and recovery lengths vary over the weeks. The training sessions are collective, with 5 to 20 participants, supervised by two experienced instructors, a TCC and a fitness instructor.

Tai Chi Chuan Plus Walking
WalkingOTHER

Participants perform a 12-week training program with two weekly exercise sessions on non-consecutive days. The sessions last 30 minutes (5 minutes of warm-up, 20 minutes of walking, and 5 minutes of cool-down) throughout the intervention period. The intervention occurs in an indoor sports court at the School of Physical Education, Federal University of Pelotas. In the walking sections, the intensity of the effort and recovery periods are controlled through the Rate of Perceived Exertion (RPE) using the Borg scale 6-20. Effort and recovery periods are on 13 and 11 RPE, respectively. The effort and recovery lengths vary over the weeks. The training sessions are collective, with 5 to 20 participants, supervised by two experienced instructors, a TCC and a fitness instructor.

Walking

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not be engaged in any regular and systematic strength and aerobic training with a frequency greater than one session per week in the previous six months;
  • To live in Pelotas without the intention of moving or traveling during the intervention period.

You may not qualify if:

  • Language and cognition problems (accessed through the Mini-Mental State Examination, minimum score ≥28 points for people with \>11 years of schooling, ≥23 points for people with 1-11 years of schooling, and ≥16 points for illiterate);
  • History of cardiovascular diseases (except medication-controlled hypertension);
  • Osteoarticular limitations that may impair physical exercise performance, such as fracture, prosthesis placement, or severe injury in the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Educação Física e FIsioterapia

Pelotas, Rio Grande do Sul, 96055630, Brazil

Location

Related Publications (1)

  • Vasconcelos BB, Freitas MP, Crochemore-Silva I, Alberton CL. Effects of a 12-week Tai Chi Chuan combined with walking program on physical and mental parameters of older adults: rationale and methodological protocol for a randomized controlled trial. Trials. 2025 Oct 27;26(1):446. doi: 10.1186/s13063-025-09190-1.

MeSH Terms

Conditions

Motor Activity

Interventions

Tai JiWalking

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Cristine L Alberton, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Breno B Vasconcelos, Msc

CONTACT

Luana S Andrade, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty healthy and physically inactive subjects, 60 to 75 years of age, are recruited. Participants are randomly allocated on a 1:1 ratio to a 12-week intervention of Tai Chi Chuan plus walking program twice a week, or an active-control group of walking twice a week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 23, 2024

Study Start

May 20, 2024

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations