Comparison of Effects of Motor, Sensory and Cognitive Exercises on Falls Prevention

NCT ID: NCT05465720

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-08-30

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.

Conditions

Motor, Sensory, Cognition, Older, Falls, Balance Ability, Randomized Controlled Trial, Task-oriented Approach

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

motor

Group Type: ACTIVE_COMPARATOR

falls-prevention programs

Intervention Type: BEHAVIORAL

Each group will receive 10-minute warm up, followed by 20-minute exercises in the ICF body function level, 20-minute exercises in the ICF activity level, and finally 10-minute cool down. The 10-minute war up include dynamic mobility exercises of the upper extremity and trunk (ribbons dancing on a chair) and of the lower extremity (marching in place). The 10-minute cool down include flexibility exercises of multiple muscles especially focusing on neck, hamstring, and calf muscles.

sensory

Group Type: EXPERIMENTAL

falls-prevention programs

Intervention Type: BEHAVIORAL

Each group will receive 10-minute warm up, followed by 20-minute exercises in the ICF body function level, 20-minute exercises in the ICF activity level, and finally 10-minute cool down. The 10-minute war up include dynamic mobility exercises of the upper extremity and trunk (ribbons dancing on a chair) and of the lower extremity (marching in place). The 10-minute cool down include flexibility exercises of multiple muscles especially focusing on neck, hamstring, and calf muscles.

cognitive

Group Type: EXPERIMENTAL

falls-prevention programs

Intervention Type: BEHAVIORAL

Each group will receive 10-minute warm up, followed by 20-minute exercises in the ICF body function level, 20-minute exercises in the ICF activity level, and finally 10-minute cool down. The 10-minute war up include dynamic mobility exercises of the upper extremity and trunk (ribbons dancing on a chair) and of the lower extremity (marching in place). The 10-minute cool down include flexibility exercises of multiple muscles especially focusing on neck, hamstring, and calf muscles.

Interventions

falls-prevention programs

Each group will receive 10-minute warm up, followed by 20-minute exercises in the ICF body function level, 20-minute exercises in the ICF activity level, and finally 10-minute cool down. The 10-minute war up include dynamic mobility exercises of the upper extremity and trunk (ribbons dancing on a chair) and of the lower extremity (marching in place). The 10-minute cool down include flexibility exercises of multiple muscles especially focusing on neck, hamstring, and calf muscles.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Responsible Party

Huiya Chen

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id