Clinical trial NCT05225181: Effects of the Combining Physical Exercise and Cognitive Training for the Community-based Elderly
Official title: Effects of the Combining Physical Exercise and Cognitive Training for the Community-based Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitively-normal
Mild Cognitive Impairment
Subjective Cognitive Decline
Keywords: aerobic exercise
cognitive training
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change scores of the Montreal Cognitive Assessment (MoCA).
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Wechsler Memory Scale (WMS)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Stroop test
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Color trials test
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
Secondary outcomes:
measure: Change scores of Verbal fluency tests
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Wechsler Adult Intelligence Scale; WAIS
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Dual-task tests
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Six-minute walk test,6MWT
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Timed up and go (TUG)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of 30 second chair stand test,CST
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of International Physical Activity Questionnaires (IPAQ)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Grip strength
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of short physical performance battery,SPPB
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of The Clinical Frailty Scale (CFS)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Reported Edmonton Frail Scale (REFS)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD)
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Geriatric Depression Scale,GDS
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
measure: Change scores of Community Integration Questionnaire, CIQ
timeFrame: baseline, after the intervention eight weeks, and at 3-month follow-up.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memotial Hospital
Study officials:
References: