NCT05225181

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 24, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

January 23, 2022

Last Update Submit

February 8, 2022

Conditions

Cognitively-normalMild Cognitive ImpairmentSubjective Cognitive Decline

Keywords

aerobic exercisecognitive training

Outcome Measures

Primary Outcomes (4)

  • Change scores of the Montreal Cognitive Assessment (MoCA).

    The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • Change scores of Wechsler Memory Scale (WMS)

    including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function.

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • Change scores of Stroop test

    The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • Change scores of Color trials test

    For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.

    baseline, after the intervention eight weeks, and at 3-month follow-up.

Secondary Outcomes (16)

  • Change scores of Verbal fluency tests

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • Change scores of Wechsler Adult Intelligence Scale; WAIS

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • Change scores of the short (12-item) form of the Everyday Cognition Scale (ECog-12)

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • Change scores of Dual-task tests

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • Change scores of Six-minute walk test,6MWT

    baseline, after the intervention eight weeks, and at 3-month follow-up.

  • +11 more secondary outcomes

Study Arms (3)

sequential training

EXPERIMENTAL

first perform physical exercise followed by cognitive training

Behavioral: perform physical exerciseBehavioral: cognitive training

simultaneous training

EXPERIMENTAL

perform physical exercise and cognitive tasks simultaneously

Behavioral: perform physical exerciseBehavioral: cognitive training

control group

ACTIVE COMPARATOR

perform body stretching and health education courses

Behavioral: control group

Interventions

perform physical exerciseBEHAVIORAL

one 60-min session of physical training

sequential trainingsimultaneous training
cognitive trainingBEHAVIORAL

one 60-min session of cognitive training

sequential trainingsimultaneous training
control groupBEHAVIORAL

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

control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age≥60
  • able to follow instruction
  • MoCA\>26
  • not SCD or MCI or Dementia

You may not qualify if:

  • concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
  • have unstable cardiovascular status such as uncontrolled hypertension
  • SCD
  • age\>=60
  • SCD(from Ecog-12)
  • MoCA≥26
  • not MCI or Dementia
  • concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
  • have unstable cardiovascular status such as uncontrolled hypertension
  • MCI
  • (1)age\>=60 (2)20 ≦MoCA \< 26 (3)MCI (3)not Dementia
  • concomitant neurological conditions such as dementia, Parkinson's disease, brain tumor, brain injury and other brain diseases (such as intracranial hypertension or cerebral edema);
  • have unstable cardiovascular status such as uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memotial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive TrainingControl Groups

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Ching-yi Wu, ScD

CONTACT

#886-3-2118800cywu@mail.cgu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2022

First Posted

February 4, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 24, 2022

Record last verified: 2022-01

Locations

TW(1)