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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Mild Cognitive Impairment; Cognitively-normal; Subjective Cognitive Decline

Treatments: Behavioral: cognitive training; Behavioral: perform physical exercise; Behavioral: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05225181

202200014B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

cognitively-normal elderly

Inclusion Criteria:

1. age≥60
2. able to follow instruction
3. MoCA>26
4. not SCD or MCI or 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

Inclusion Criteria:

1. age>=60
2. SCD(from Ecog-12)
3. MoCA≥26
4. not MCI or 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

MCI

Inclusion Criteria:

(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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

sequential training

Experimental group

Description:

first perform physical exercise followed by cognitive training

Treatment:

Behavioral: perform physical exercise

Behavioral: cognitive training

simultaneous training

Experimental group

Description:

perform physical exercise and cognitive tasks simultaneously

Treatment:

Behavioral: perform physical exercise

Behavioral: cognitive training

control group

Active Comparator group

Description:

perform body stretching and health education courses

Treatment:

Behavioral: control group