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Evolving Methods of Hybrid Exercise-cognition Approach to Promote Health-related Conditions for the Elderly With MCI

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Unknown

Conditions

Stroke
Mild Cognitive Impairment

Treatments

Other: physical exercise training
Other: cognitive training

Study type

Interventional

Funder types

Other

Identifiers

NCT03927586
201600262A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

55 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 4 patient groups

cognitive training (COG group)
Experimental group
Description:
All participants will receive trainings for 90 minutes per day, three days per week for 12 weeks (a total of 36 training sessions). Each cognitive intervention session will last for 90 minutes. The COG group received computerized cognitive based training which include memory, executive function, visuospatial , language and attention trainings.
Treatment:
Other: cognitive training
physical exercise training (PE group)
Experimental group
Description:
All participants will receive trainings for 90 minutes per day, three days per week for 12 weeks (a total of 36 training sessions). Each physical exercise intervention session will last for 90 minutes. The entire exercise program for the PE group will contain 10 minutes of warm-up, 70 minutes of physical exercise, and 10 minutes of cool-down. The PE group received multimodal exercise program which includes aerobic exercise, balance and muscle strength training.
Treatment:
Other: physical exercise training
sequential training (SEQ group)
Experimental group
Description:
All participants will receive trainings for 90 minutes per day, three days per week for 12 weeks (a total of 36 training sessions). The participants in the SEQ group will first undergo physical exercise training for 45 minutes followed by 45 minutes of cognitive-based training. The participants will first perform 10 minutes of warm-up followed by 25 minutes of physical exercise, and end with 10 minutes of cool-down. The exercise intensity will be similar to the PE group. Following the physical exercise, the participants will take part in 45 minutes of cognitive training. The same tasks used in the COG group will be practiced.
Treatment:
Other: cognitive training
Other: physical exercise training
dual-task training (Dual group)
Experimental group
Description:
All participants will receive trainings for 90 minutes per day, three days per week for 12 weeks (a total of 36 training sessions). The participants in the DUAL group will be instructed to perform physical exercise and cognitive tasks simultaneously (e.g., math calculation while stepping). The difficulty of the cognitive tasks will increase as the participants improve in their performance. The 90 minutes of training session will be break up into 2 to 3 parts, and the participants can rest as needed.
Treatment:
Other: cognitive training
Other: physical exercise training

Trial contacts and locations

1

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Central trial contact

Ching-yi Wu, ScD

Data sourced from clinicaltrials.gov

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