Effects of a 12-week Tai Chi Chuan Combined With Walking Program on Physical and Mental Parameters of Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maximal dynamic strength
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Maximal dynamic strength
时间窗: Baseline (week 0) to post-training (week 13)
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.
Functional test - 30-s Chair-stand test
时间窗: Baseline (week 0) to post-training (week 13)
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.
次要结局
- Isometric back-leg-chest strength(Baseline (week 0) to post-training (week 13))
- Isometric handgrip strength(Baseline (week 0) to post-training (week 13))
- Quadriceps muscle thickness(Baseline (week 0) to post-training (week 13))
- Dynamic muscular endurance(Baseline (week 0) to post-training (week 13))
- Functional tests - arm curl(Baseline (week 0) to post-training (week 13))
- Functional tests - Back Scratch(Baseline (week 0) to post-training (week 13))
- Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref)(Baseline (week 0) to post-training (week 13))
- Functional tests - 8-ft Up-and-Go(Baseline (week 0) to post-training (week 13))
- Funcional tests - 6-min Walk(Baseline (week 0) to post-training (week 13))
- Objective cognitive function - Controlled Oral Word Association Test (COWAT)(Baseline (week 0) to post-training (week 13))
- Functional tests - Chair Sit-and-Reach(Baseline (week 0) to post-training (week 13))
- Static balance - 30-second single-leg stance test(Baseline (week 0) to post-training (week 13))
- Quadriceps muscle quality(Baseline (week 0) to post-training (week 13))
- Objective cognitive function - Trail Making Test (TMT)(Baseline (week 0) to post-training (week 13))
- Sleep quality - Pittsburgh Sleep Quality Index(Baseline (week 0) to post-training (week 13))
- Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS)(Baseline (week 0) to post-training (week 13))
研究者
Cristine Lima Alberton
Principal Investigator
Federal University of Pelotas