- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07800494
Effects of Adapted Argentine Tango Training Frequency on Dual-Task Walking (AAT-FREQ)
Effects of Adapted Argentine Tango Training Frequency Under Equal Weekly Exercise Volume on Dual-Task Walking and Executive Function in Adults Aged 55 to 60 Years: A Three-Arm Parallel Randomized Controlled Trial
This randomized controlled trial will examine whether the frequency of adapted Argentine tango training affects walking and cognitive function in adults aged 55 to 60 years when the total weekly intervention time is kept the same.
A total of 270 participants will be randomly assigned in equal numbers to one of three groups. The distributed tango group will attend five 36-minute sessions per week. The concentrated tango group will attend two 90-minute sessions per week. The active control group will attend two 90-minute sessions per week consisting of health education and low-intensity stretching. All interventions will continue for 8 weeks.
The adapted Argentine tango program will include low-impact multidirectional stepping, weight shifting, movement initiation and stopping, rhythmic cueing, direction changes, alternating leader-follower roles, and progressive movement-sequence learning. Jumping, rapid continuous turning, large kicks, and other high-risk movements will not be included.
Assessments will be conducted at baseline, Week 4, Week 8, and 2 weeks after the intervention ends. The main outcome will be the change in dual-task walking cost at week 8. Other assessments will examine balance, walking performance, executive function, general cognitive function, lower-limb function, exercise adherence, training intensity, falls, and adverse events.
The study aims to determine whether shorter, more frequent sessions or longer, less frequent sessions provide greater motor-cognitive benefits when the total weekly intervention time is equal.
Přehled studie
Postavení
Detailní popis
Dance combines aerobic activity, dynamic balance, rhythmic movement, motor-sequence learning, spatial orientation, and cognitive-motor coordination. Adapted Argentine tango may be particularly suitable for improving motor-cognitive function because it requires multidirectional stepping, weight shifting, movement initiation and cessation, direction changes, rhythmic synchronization, and continuous planning of subsequent movements.
Previous dance intervention studies have varied substantially in dance style, training frequency, session duration, exercise intensity, and total training volume. Consequently, it remains unclear whether the distribution of training sessions across the week independently influences motor-cognitive outcomes. This study will compare two adapted Argentine tango schedules while maintaining the same total weekly intervention time.
This will be a single-center, three-arm, parallel randomized controlled trial involving 270 adults aged 55 to 60 years. After eligibility screening, written informed consent, and baseline assessment, participants will be randomly allocated in a 1:1:1 ratio to a distributed tango group, a concentrated tango group, or an active control group. Randomization will be stratified by sex and implemented using variable block sizes. Outcome assessors and statistical analysts will be blinded to group allocation whenever feasible.
Participants in the distributed tango group will complete five 36-minute sessions per week, providing a total weekly intervention time of 180 minutes. Each session will consist of approximately 6 minutes of warm-up, 24 minutes of adapted tango, and 6 minutes of cool-down. Participants in the concentrated tango group will complete two 90-minute sessions per week, also providing 180 minutes per week. Each session will consist of approximately 15 minutes of warm-up, 60 minutes of adapted tango, and 15 minutes of cool-down, with appropriate rest and water breaks. Participants in the active control group will complete two 90-minute sessions per week consisting of general health education, low-intensity joint mobility exercises, stretching, and relaxation activities. The control program will not include systematic tango steps, progressive movement-sequence learning, or cognitively demanding direction-switching tasks.
The adapted Argentine tango intervention will be progressively delivered over 8 weeks. Early sessions will emphasize postural control, weight shifting, forward stepping, and lateral stepping. Subsequent sessions will introduce backward stepping, movement initiation and stopping, rhythm changes, small crossover steps, and controlled 90-degree turns. Later sessions will incorporate alternating leader-follower roles, music- and direction-based cues, progressively longer movement sequences, and low-difficulty dual-task activities. High-risk movements, including jumping, rapid continuous spinning, deep lunges, large kicks, boleos, ganchos, and eyes-closed movement, will be excluded.
Tango exercise intensity will be targeted at approximately 50% to 65% of heart rate reserve, with a rating of perceived exertion of 11 to 13. Attendance, actual exercise duration, average and peak heart rate, session rating of perceived exertion, interruptions, discomfort, falls, and other adverse events will be recorded throughout the intervention.
Study assessments will be conducted at baseline, week 4, week 8, and 2 weeks after completion of the intervention. Week 8 will be the primary endpoint. No study-provided training will be delivered during the 2-week follow-up period. Physical activity and participation in other exercise programs during follow-up will be documented.
The primary outcome will be the between-group difference in the change from baseline to week 8 in dual-task walking cost. Dual-task walking cost will be calculated from walking speed under single-task and dual-task conditions. Secondary assessments will evaluate dynamic balance, complex mobility, walking performance, executive function, general cognitive function, lower-limb functional performance, walking endurance, intervention adherence, exercise intensity, falls, withdrawals, and adverse events.
The primary analysis will follow the intention-to-treat principle. Longitudinal outcomes will be analyzed using mixed-effects models including group, time, and group-by-time interaction effects. Effect estimates will be reported with 95% confidence intervals. Appropriate adjustment for multiple comparisons and sensitivity analyses for missing data will be conducted according to a prespecified statistical analysis plan.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Xiaodong Cheng, PhD
- Telefonní číslo: +86-15289209110
- E-mail: chengxiaodong@xiyi.edu.cn
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Aged 55 to 60 years at the time of enrollment. Able to stand and walk independently without physical assistance from another person.
Able to understand the study procedures and complete the walking, balance, physical function, and cognitive assessments.
No regular dance training during the previous 6 months. Willing to maintain usual daily activities and avoid beginning another structured dance or balance-training program during the study.
Cleared for moderate-intensity exercise based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) or an equivalent exercise safety screening. Medical clearance will be required when indicated.
Willing and able to attend the assigned intervention sessions and complete the scheduled assessments.
Able to provide written informed consent.
Exclusion Criteria:
Uncontrolled hypertension, unstable angina, recent myocardial infarction or stroke, severe cardiac arrhythmia, or another cardiovascular condition that makes moderate-intensity exercise unsafe.
A neurological disorder that substantially affects gait, balance, cognition, or the ability to complete the study procedures.
Severe cognitive impairment, psychiatric illness, or communication difficulty that prevents understanding of the study or valid completion of the assessments.
A recent fracture, severe musculoskeletal disorder, acute joint injury, severe dizziness, or another condition associated with an unacceptably high risk of falling or exercise-related injury.
Current participation in another structured dance, balance, cognitive-motor, or exercise intervention study that may affect the study outcomes.
Any other medical or functional condition that, in the judgment of the study investigator or qualified safety assessor, makes participation unsafe or may interfere with completion of the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Distributed Adapted Argentine Tango
Participants will complete adapted Argentine tango training five times per week for 8 weeks.
Each 36-minute session will include approximately 6 minutes of warm-up, 24 minutes of adapted tango, and 6 minutes of cool-down, providing a total intervention time of 180 minutes per week.
|
Participants will complete five 36-minute sessions per week for 8 weeks.
Training will include low-impact multidirectional stepping, weight shifting, forward and backward stepping, lateral stepping, movement initiation and stopping, rhythm changes, controlled 90-degree turns, alternating leader-follower roles, and progressive motor-sequence learning.
The target intensity will be approximately 50% to 65% of heart rate reserve, with a rating of perceived exertion of 11 to 13. Jumping, rapid continuous turning, large kicks, deep lunges, boleos, ganchos, and eyes-closed movements will be excluded.
Ostatní jména:
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Experimentální: Concentrated Adapted Argentine Tango
Participants will complete adapted Argentine tango training twice per week for 8 weeks.
Each 90-minute session will include approximately 15 minutes of warm-up, 60 minutes of adapted tango, and 15 minutes of cool-down, with appropriate rest and water breaks, providing a total intervention time of 180 minutes per week.
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Participants will complete two 90-minute sessions per week for 8 weeks.
The adapted tango content, progression, weekly intervention time, and target exercise intensity will be matched to the distributed tango group.
Each session will include warm-up, 60 minutes of core adapted tango training, cool-down, and appropriate rest and water breaks.
High-risk movements will be excluded.
Ostatní jména:
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Experimentální: Active Control
Participants will attend two 90-minute sessions per week for 8 weeks.
Sessions will consist of general health education, low-intensity joint mobility exercises, stretching, breathing exercises, and relaxation activities.
The program will not include systematic tango steps, progressive movement-sequence learning, or cognitively demanding direction-switching tasks.
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Participants will complete two 90-minute sessions per week for 8 weeks.
The program will include general health education, low-intensity joint mobility exercises, stretching, breathing exercises, and relaxation.
It will not include systematic dance training, progressive tango sequences, multidirectional stepping practice, or cognitively demanding movement-switching tasks.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Dual-Task Walking Cost at Week 8
Časové okno: Baseline and Week 8
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Dual-task walking cost will be calculated using walking speed under single-task and dual-task conditions according to the following formula: [(single-task walking speed - dual-task walking speed) / single-task walking speed] × 100%.
Walking speed will be measured in meters per second.
A higher percentage indicates greater dual-task interference and poorer motor-cognitive performance.
The primary analysis will compare the change from baseline to Week 8 among the three study groups.
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Baseline and Week 8
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- AAT-FREQ-RCT-2026-01
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
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