Clinical trial NCT05465720: Comparison of Effects of Motor, Sensory and Cognitive Exercises on Falls Prevention
Official title: "Invisible" Balance Problems: the Comparison of Effects of Motor, Sensory and Cognitive Exercises on Falls Prevention in Community Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor, Sensory, Cognition, Older, Falls, Balance Ability, Randomized Controlled Trial, Task-oriented Approach
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Motor, sensory, and cognitive functions all contribute to balance maintenance, and age causes deterioration in these functions with associated declines in balance ability and accidental falls. Relatively speaking, the sensory and cognitive functions are "invisible" in designing falls-prevention programs. The relative proportions of training of motor, sensory, and cognitive functions, for the most efficient falls-prevention program is a practical and important issue but has not been studied yet by directly comparing their intervention effects.

This three-year project aims to provide evidence base for relative proportions of motor, sensory, and cognitive training when designing falls-prevention programs. The crossover randomized controlled trial (RCT) will recruit 120 community-dwelling elderly adults from local community centers. There will two experimental groups- sensory and cognitive training, one control group- motor training, each for 60 minutes per session, 3 times a week, for 16 weeks. The three groups will be trained with task-oriented design of balance exercise but focusing on different aspects, i.e., training will begin in the ICF body function level (focusing on motor, sensory, or cognitive function) in the stance position and will end in the ICF activity level (balance or mobility activities focusing on motor, sensory, or cognitive function). The primary outcome measures are rates of falls and near-falls in the ICF participation level, and the secondary measures are balance/mobility performance and risk of falling in the ICF activity level.

In Taiwan, a great amount of expense is paid to prevent falls in the community setting. Through better understanding of the comparative intervention effects between motor, sensory, and cognitive training, this project hope to be able to suggest the relative proportions of motor, sensory, and cognitive training in falls-prevention exercise design.


Eligibility criteria: Inclusion Criteria:

* (1) older than 60 years of age, (2) living in the community, (3) scored more than two in Mini-Cog assessment \[51\], and (4) able to walk independently or with minimal assistance in the community

Exclusion Criteria:

* (1) an injury or musculoskeletal system disorder that would hamper their ability to conduct the physical tests, (2) acute heart attack in recent 3-6 months or unstable angina, (3) uncontrolled atrial or ventricular arrhythmias, (4) aortic dissecting aneurysm, (5) severe aortic stenosis, (6) acute endocarditis/pericarditis, (7) uncontrolled blood pressure higher than 180/110 mmHg, (8) acute thromboembolism, (9) acute or severe heart failure, (10) acute or severe respiratory failure, (11) uncontrolled postural hypotension, (12) uncontrolled acute decompensated diabetes mellitus or low blood sugar, (13) any other circumstance the doctors believe prevents dosing physical activity.

Primary outcomes:
measure: Short form of Falls Efficacy Scale International
timeFrame: 5 minutes
measure: Taiwan International Physical Activity Questionnaire-Short Form
timeFrame: 10 minutes
measure: Rate of falls
timeFrame: 3 minutes
measure: Rate of near-falls
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
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Study officials:
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