Multicomponent Exercise in People With Dementia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia
• Intervention / Treatment: Other: Multicomponent exercise; Other: Video home exercise group

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yea-Ru Yang, Professor; Phone Number: +886-2-28267279; Email: yryang@nycu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multicomponent exercise group	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
Active Comparator: Video home exercise group	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Chinese version of Stroop color and word test	It is a measurement to evaluate inhibition control.	Change from baseline at 9 week
Digit span test	It is a measurement to evaluate working memory.	Change from baseline at 9 week
Trail making test - Chinese version	It is a measurement to evaluate cognitive flexibility.	Change from baseline at 9 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Time up and go test	It is a test to evaluate functional mobility.	Change from baseline at 9 week
30-second chair stand test	It is a test to evaluate muscle strength.	Change from baseline at 9 week
6-minute walk test	It is a test to evaluate endurance.	Change from baseline at 9 week
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

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: YM110062F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No