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AgingNCT06380413

Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults

A study testing Tai Chi Chuan Plus Walking and Walking in people with Aging, run by Federal University of Pelotas at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Tai Chi Chuan Plus Walking and Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
20 May 2024to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Breno B Vasconcelos, Msc contact

+55 53 98432 2403

brenobvasc@gmail.com

Luana S Andrade, PhD contact

+55 53 99982 1398

andradelu94@gmail.com

Brazil1 site
  • Escola Superior de Educação Física e FIsioterapia

    Pelotas, Rio Grande do Sul, 96055630

    Cristine L Alberton, PhD

Other trials in Brazil

About this study

Official title: Effects of a 12-week Tai Chi Chuan Combined With Walking Program on Physical and Mental Parameters of Older Adults: A Randomized Controlled Trial

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.

Conditions
Aging
Being tested
Tai Chi Chuan Plus Walking, Walking
Keywords
physical exercise, tai chi chuan, walking, muscle strength, physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai Chi Chuan Plus WalkingOther

    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.

  • 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.

Study groups in NCT06380413
Study groupRoleWhat they receive
Tai Chi Chuan Plus WalkingExperimentalTai Chi Chuan plus walking program twice a week
Receives: Other: Tai Chi Chuan Plus Walking
WalkingActive comparatorWalking program twice a week
Receives: Other: Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (16)
  1. Dynamic muscular endurance

    The same knee extension machine is used to assess dynamic muscular endurance. To do so, participants perform the maximal number of bilateral knee extension repetitions at 60% of their 1RM. The test cadence (2 s for each contraction phase) and range of motion are the same for the 1RM test. The post-intervention assessment is performed using the same absolute load employed at baseline (i.e., 60% of baseline 1RM).

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

  2. Isometric handgrip strength

    The Handgrip isometric strength will be accessed using a handgrip dynamometer (Jamar, Sammons Preston Inc.®). Participants must be seated and with the elbow of the limb to be evaluated flexed at 90° without any external support. Both hands will be measured. On command, participants must squeeze the dynamometer as hard as possible for 5 seconds. Three attempts will be made for each hand, with a 1-minute interval between attempts, and the highest value achieved will be recorded, which is measured in Kilogram-Force (kgf).

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

  3. Isometric back-leg-chest strength

    The isometric back-leg-chest strength will be accessed using the back-leg-chest dynamometer (Crown, Oswaldo Filizola Ltda.), as illustrated in Figure 19. Participants must position themselves on the equipment platform with their knees extended, hips flexed at approximately 60 degrees, hands holding the equipment bar, and look straight ahead. On command, participants must pull the dynamometer upwards, exerting as much force as possible. Three attempts will be made with a 1-minute interval between attempts, and the highest value achieved will be recorded, which is measured in Kilogram-Force (kg).

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

  4. Functional tests - arm curl

    The Arm Curl test is performed to measure the strength of the upper limbs. Starting at full elbow extension and holding a 2 kg dumbbell in each hand, participants are instructed to perform the maximal number of elbow crunches over the full range of motion for 30 s. The test is performed with both upper limbs.

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

  5. Functional tests - 8-ft Up-and-Go

    The 8-ft Up-and-Go test is performed to measure agility and dynamic balance. Participants are instructed to get up from the chair (43 cm), turn around a marker that will be 2.44m, and return to the starting position. The shortest time of two attempts will be considered as a result.

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

  6. Functional tests - Chair Sit-and-Reach

    The Chair Sit-and-Reach test is performed to measure the flexibility of the lower limbs. Participants sit on the front edge of a chair and extend one leg straight out in front of the hip, with foot flexed and heel resting on the floor (the other leg is bent, foot flat on the floor). The object is to reach as far forward as possible toward (or past) the toes. The investigator uses a ruler noting the cm left to reach the toe (negative score) or the cm that went past the toe (positive score).

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

  7. Functional tests - Back Scratch

    The Back Scratch test is performed to measure the flexibility of the upper limbs. Participants are instructed to try to touch the middle fingers of both hands together behind the back. The investigator uses a ruler noting the cm left to reach the middle fingers (negative score) or the cm that the middle fingers overlapped (positive score).

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

  8. Funcional tests - 6-min Walk

    The 6-min Walk test is performed to measure aerobic fitness. The course proposed in the original test is 45.72 m rectangular. The course will be adapted for a straight line with 30 m length, demarcated with cones every 3 m. Participants are instructed to walk for 6-min in a flat 30m course, in which the total distance walked "as fast as possible" is assessed.

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

  9. Static balance - 30-second single-leg stance test

    The static balance will be determined through the 30-second single-leg stance test (Briggs et al., 1989). The subjects will be positioned facing the wall, at a distance at which they can rest their hands on the wall at shoulder height with their elbows extended. They will be asked to choose one of their lower limbs, whichever they feel most comfortable balancing on. At the signal, they will be asked to look at a fixed point on the wall, lower their upper limbs, keeping them glued to the body in an orthostatic position, and flex the knee of the lower limb not chosen to approximately 90 degrees, remaining in single-leg support. Three attempts will be made, and the longest time (30 s maximum) that participants are able to maintain a single-leg balance will be recorded.

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

  10. Quadriceps muscle thickness

    Transversal images of the four portions of the quadriceps femoris are obtained by B-mode ultrasonography with a 7.5 megahertz linear array probe. Images of the vastus lateralis (VL), rectus femoris (RF), and vastus intermedius (VI) muscles are obtained at the midpoint between the anterosuperior iliac spine and the upper edge of the patella, whereas the vastus medialis (VM) is assessed at 30% of the distance between the lateral condyle and the greater trochanter of the femur. All images will be analyzed using the ImageJ software (National Institutes of Health, USA, version 1.37). The muscle thickness will be assessed as the distance from each muscle's superior and inferior muscle aponeurosis. Overall quadriceps femoris muscle thickness will be calculated as the sum of each muscle thickness (i.e., RF + VL + VM + VI).

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

  11. Quadriceps muscle quality

    Transversal images of the four portions of the quadriceps femoris are obtained by B-mode ultrasonography with a 7.5 megahertz linear array probe. Images of the VL, RF, and VI muscles are obtained at the midpoint between the anterosuperior iliac spine and the upper edge of the patella, whereas the VM is assessed at 30% of the distance between the lateral condyle and the greater trochanter of the femur. All images will be analyzed using the ImageJ software. Muscle quality will be determined by the echo intensity values, which will be calculated from gray-scale analysis using the standard histogram function in ImageJ. The echo intensity of the quadriceps femoris will be calculated as the mean of echo intensity values of the four individual quadriceps femoris muscles ((RF + VL + VM + VI)/4).

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

  12. Objective cognitive function - Trail Making Test (TMT)

    Aspects of objective cognitive function are measured by the Trail Making Test (TMT). The version validated for the Brazilian population of TMT (Carvalho \& Caramelli, 2020) is used to assess domains such as attention, motor skills, processing speed and cognitive flexibility (Bowie \& Harvey, 2006). In the first part of the instrument (TMT-A), participants will have to draw a line connecting the numbers from 1 to 25 in ascending order. Then, letters (A-L) will be added so that the participants trace a line again following a numerical (1-13) and alphabetical order, interleaved (TMT-B). Participants will be instructed to maintain pencil-to-paper contact during the test. A shorter runtime indicates better performance.

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

  13. Objective cognitive function - Controlled Oral Word Association Test (COWAT)

    Aspects of objective cognitive function are also measured by the Controlled Oral Word Association Test (COWAT). The COWAT is used to assess verbal fluency, working memory and inhibitory control (Ross et al., 2007). In this test the participants will have to speak as many words as possible that start with the letters "F", "A" and "S", within 1 minute for each letter. Proper names, repeated words and variations in gender, number and conjugation will not be considered. The greater number of words evoked in each test indicates better verbal fluency.

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

  14. Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref)

    Quality of life will be measured using the Abbreviated World Health Organization Quality of Life (WHOQOL-Bref) questionnaire, a validated version in Brazilian Portuguese (Fleck et al., 2000). The questionnaire has 26 questions, two general questions about quality of life, and 24 divided into four domains with six questions each: physical, psychological, social relationships, and environment.

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

  15. Sleep quality - Pittsburgh Sleep Quality Index

    The participants' perceived sleep quality will be measured using the Pittsburgh Sleep Quality Index, a validated version in Brazilian Portuguese (Passos et al., 2017). The questionnaire has 19 self-rated questions and five questions rated by the bed partner or roommate (if any) that investigate the quality and possible sleep disturbances during the last month across seven domains: subjective quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, medication use, and daily dysfunction. Each domain has a score that varies from 0 to 3 points, totaling a maximum of 21 points. Scores above 5 points indicate poor sleep quality. The questions evaluated by the partner/colleague are not considered when calculating the final score and, for logistical reasons, will be removed from the data collection instrument.

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

  16. Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS)

    HADS was developed by Zigmond and Snaith (1983), with translation and validation for the Brazilian population (Botega et al., 1995). It is an instrument composed of 14 items, seven of which form the anxiety subscale and the other seven the depression subscale, allowing the assessment of symptoms in the previous week. Each HADS item has four response options ranging from 0 to 3, reaching a maximum of 21 points in each subscale.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start20 May 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06380413
Sponsor's protocol ID
78972024.7.0000.5313
Status last verified
Apr 2024
First submitted
17 Apr 2024
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41146306

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi Chuan Plus Walking and Walking in people with Aging, run by Federal University of Pelotas at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Breno B Vasconcelos, Msc (+55 53 98432 2403, brenobvasc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal dynamic strength (time frame: Baseline (week 0) to post-training (week 13)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06380413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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