Effects of the Combining Physical Exercise and Cognitive Training for the Community-based Elderly

NCT ID: NCT05225181

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-31

Brief Summary

This study aims to (1) determine the intervention effects of sequential and simultaneous training on cognitive function and health-related function for cognitively-normal elderly and elderly with Mild Cognitive Impairment(MCI) and Subjective Cognitive Decline(SCD); (2) compare which combination approach is more advantageous for improvement on outcome measures.

Detailed Description

The investigators will recruit 30 cognitively-normal elderly and 30 elderly with Mild Cognitive Impairment(MCI) and 30 elderly with Subjective Cognitive Decline(SCD). Participants will be randomly assigned to one of three groups: sequential training (first perform physical exercise followed by cognitive training), simultaneous training (perform physical exercise and cognitive tasks simultaneously), and control group (perform body stretching and health education courses). All participants will receive trainings for 120 minutes per day, one day per week for 12 weeks. The outcome will include measurements that evaluate the cognitive, physical, daily functions, quality of life, and social participation. Participants will be assessed at baseline, after the intervention, and at 3-month follow-up. Repeated measures of analysis of variance (ANOVA) will be used to evaluate the changes in outcome measures at three different time points for the elderly with cognitively-normal, Mild Cognitive Impairment(MCI) and Subjective Cognitive Decline(SCD), respectively. The investigators also use the analysis of covariance (ANCOVA) to investigate the differences between the Mild Cognitive Impairment(MCI) and Subjective Cognitive Decline(SCD) groups on the outcome measures.

Conditions

Cognitively-normal; Mild Cognitive Impairment; Subjective Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

sequential training

first perform physical exercise followed by cognitive training

Group Type: EXPERIMENTAL

perform physical exercise

Intervention Type: BEHAVIORAL

one 60-min session of physical training

cognitive training

Intervention Type: BEHAVIORAL

one 60-min session of cognitive training

simultaneous training

perform physical exercise and cognitive tasks simultaneously

Group Type: EXPERIMENTAL

perform physical exercise

Intervention Type: BEHAVIORAL

one 60-min session of physical training

cognitive training

Intervention Type: BEHAVIORAL

one 60-min session of cognitive training

control group

perform body stretching and health education courses

Group Type: ACTIVE_COMPARATOR

control group

Intervention Type: BEHAVIORAL

perform body stretching(15min) and health education courses(90min)

Interventions

perform physical exercise

one 60-min session of physical training

Intervention Type: BEHAVIORAL

cognitive training

one 60-min session of cognitive training

Intervention Type: BEHAVIORAL

control group

perform body stretching(15min) and health education courses(90min)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. age≥60

2. able to follow instruction

3. MoCA>26

4. not SCD or MCI or Dementia

1. age>=60

2. SCD(from Ecog-12)

3. MoCA≥26

4. not MCI or Dementia

(1)age>=60 (2)20 ≦MoCA < 26 (3)MCI (3)not Dementia

Exclusion Criteria

1. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);

2. have unstable cardiovascular status such as uncontrolled hypertension

SCD

1. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);

2. have unstable cardiovascular status such as uncontrolled hypertension

MCI

1. concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);

2. have unstable cardiovascular status such as uncontrolled hypertension

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

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memotial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Central Contacts

Ching-yi Wu, ScD

Role: CONTACT

cywu@mail.cgu.edu.tw

#886-3-2118800 ext. 5761

Facility Contacts

Ching-Yi Wu, ScD

Role: primary

cywu@mail.cgu.edu.tw

+886-3-2118800 ext. 5761

Other Identifiers

202200014B0

Identifier Type: -

Identifier Source: org_study_id