Multicomponent Exercise in People With Dementia

Dementia Clinical Trial

Official title:

Effect of Multicomponent Exercise on Cognitive Function and Activities of Daily Living in People With Dementia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04951258
• Other study ID #: YM110062F
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: National Yang Ming University
• Contact: Yea-Ru Yang, Professor
• Phone: +886-2-28267279
• Email: yryang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People with dementia shows a decline in cognition, such as memory, executive function (EF), language, attention, and spatial orientation that is significant enough to interfere with the independence and daily functioning. Previous studies reported that multicomponent exercise improved EF in people with mild cognitive impairment and independence of ADL in those with Alzheimer's disease. However, few studies investigated whether multicomponent exercise improved EF, memory, and ADL in people with dementia. Therefore, the purposes of this study are to examine 1) the effect of multicomponent exercise on EF, memory, and ADL in people with mild to moderate dementia; 2) the correlation between change in EF and ADL; 3) the correlation between change in memory and ADL.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age: 60-80 y/o

• Mini-Mental State Examination: 10-26

• Clinical Dementia Rating: 1-2

• Walk at least 6 meters independently (with or without walking aids)

Exclusion Criteria:

• Any other diagnosis of neurological diseases or musculoskeletal problems (Except dementia)

• Physical or psychological comorbidities that affect performance during assessment or intervention

• Already participating in other physical training in the last 1 month

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Multicomponent exercise
The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Multicomponent exercise included strengthening, balance training, aerobic dance, and stretching
• Video home exercise group
The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Video home exercise included four limbs mobility exercise, stretching, strengthening, and aerobic exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Mental State Examination	It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher scores mean a better outcome.	Change from baseline at 9 week
Primary	Chinese version of Verbal learning test	It is a 9-point measurement to evaluate memory. Higher scores mean a better outcome.	Change from baseline at 9 week
Primary	Chinese version of Stroop color and word test	It is a measurement to evaluate inhibition control.	Change from baseline at 9 week
Primary	Digit span test	It is a measurement to evaluate working memory.	Change from baseline at 9 week
Primary	Trail making test - Chinese version	It is a measurement to evaluate cognitive flexibility.	Change from baseline at 9 week
Secondary	Barthel index	It is a 100-point ordinal scale used to measure performance in activities of daily living. Higher scores mean a better outcome.	Change from baseline at 9 week
Secondary	Instrumental activities of daily living (IADL) scale	It is a 24-point ordinal scale used to measure performance in instrumental activities of daily living. Higher scores mean a better outcome.	Change from baseline at 9 week
Secondary	Chinese version of Quality of Life in Alzheimer Disease Scale	It is a measurement to evaluate quality of life. The scale scores range from 13 to 52, with higher scores indicating greater quality of life.	Change from baseline at 9 week
Secondary	Time up and go test	It is a test to evaluate functional mobility.	Change from baseline at 9 week
Secondary	30-second chair stand test	It is a test to evaluate muscle strength.	Change from baseline at 9 week
Secondary	6-minute walk test	It is a test to evaluate endurance.	Change from baseline at 9 week
Secondary	Berg Balance Scale	It is a tool to evaluate balance. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.	Change from baseline at 9 week