Clinical trial NCT03927586: Evolving Methods of Hybrid Exercise-cognition Approach to Promote Health-related Conditions for the Elderly With MCI
Official title: Evolving Methods of Hybrid Exercise-cognition Approach to Promote Health-related Conditions for the Elderly With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Stroke
Keywords: aerobic exercise
cognitive training
hybrid therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to determine: (1) the effects of combined physical exercise and cognitive training versus exercise or cognitive training alone on cognition, physical function, daily function, quality of life and social participation outcomes, (2) determine the relative effects of simultaneous vs. sequential combination of physical exercise and cognitive training on these health-related outcomes, (3) determine the long-term effects of different types of trainings on these outcome measures.

Detailed description: Mild cognitive impairment (MCI) or minor neurocognitive disorder involves problems with memory, executive function and language. The age-adjusted prevalence of MCI in Taiwan is approximately 18%. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in five years. Early detection and intervention of the individuals with MCI may help delay or prevent progress from MCI to dementia, and reduce the burden of their caregivers and the medical expenses of the health-care system. Whilst numerous studies have established the potential benefits of cognitive or physical exercise training on cognition for individuals with MCI, some recent studies suggested that combining physical exercise and cognitive training may augment the intervention effects. Also, different combination methods - combining physical exercise and cognitive training either sequentially or simultaneously under a dual-task paradigm may impose differential cognitive challenges on the participants, and it is yet not clear which combination strategy has better training effects.

Eligibility criteria: Inclusion Criteria:

* able to follow instruction,
* age 55 to 90 years old,
* clinical dementia rating (CDR) = 0.5 or 1,
* self- or informant-reported memory or cognitive complaints,
* able to perform activities of daily living (Barthel Index ≥ 70).

Exclusion Criteria:

* Participants will be excluded if they have recent myocardial infarction, heart failure, recent heart surgery, severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.

Primary outcomes:
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Verbal fluency test
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Useful Field of View (UFOV)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Stroop Color-Word test
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Dual-task test
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Timed up and go (TUG)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Sit-to-stand test
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of International Physical Activity Questionnaires (IPAQ)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Mobility level
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Lower extremity muscle strength
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Grip strength
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of the Barthel Index (BI)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of the Disability Assessment for Dementia (DAD)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of the Quality of Life in Alzheimer's Disease Instrument (QoLAD)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Community Integration Questionnaire (CIQ)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Caregiver Burden Inventory (CBI)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
measure: Change scores of Short form of Geriatric Depression Scale (GDS)
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline), follow up test (6 months after completing intervention sessions)
Secondary outcomes:
measure: Change scores of serum BDNF level
timeFrame: Baseline, post test immediately after completing 36 intervention sessions (around 12 weeks after baseline)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: