Clinical trial NCT06380413: Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Keywords: physical exercise
tai chi chuan
walking
muscle strength
physical activity
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximal dynamic strength
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional test - 30-s Chair-stand test
timeFrame: Baseline (week 0) to post-training (week 13)
Secondary outcomes:
measure: Dynamic muscular endurance
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Isometric handgrip strength
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Isometric back-leg-chest strength
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - arm curl
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - 8-ft Up-and-Go
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - Chair Sit-and-Reach
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Functional tests - Back Scratch
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Funcional tests - 6-min Walk
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Static balance - 30-second single-leg stance test
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Quadriceps muscle thickness
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Quadriceps muscle quality
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Objective cognitive function - Trail Making Test (TMT)
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Objective cognitive function - Controlled Oral Word Association Test (COWAT)
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref)
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Sleep quality - Pittsburgh Sleep Quality Index
timeFrame: Baseline (week 0) to post-training (week 13)
measure: Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (week 0) to post-training (week 13)
Other outcomes:
measure: Body mass
timeFrame: Baseline (week 0)
measure: Height
timeFrame: Baseline (week 0)
measure: Waist and hip circumferences
timeFrame: Baseline (week 0)
measure: Monitoring the intensity of training sessions - Borg Category-Ratio 10 (CR-10)
timeFrame: Intervention period (week 1 to week 12)
measure: Follow-up questionnaire
timeFrame: Post-training (week 13)
measure: Adherence assessments
timeFrame: Intervention period (week 1 to week 12)
measure: Health Questionnaire
timeFrame: Baseline (week 0)
measure: Level of physical activity - International Physical Activity Questionnaire (IPAQ) - extended version
timeFrame: Baseline (week 0)
measure: Cognitive screening - Mini-mental state examination (MMSE)
timeFrame: Baseline (week 0)
Locations:
city: Pelotas
country: Brazil
facility: Escola Superior de Educação Física e FIsioterapia
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Pelotas
name: Cristine L Alberton, PhD
role: PRINCIPAL_INVESTIGATOR
References: