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

NCT ID: NCT03927586

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2021-12-31

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.

Conditions

Mild Cognitive Impairment; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

cognitive training (COG group)

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.

Group Type: EXPERIMENTAL

cognitive training

Intervention Type: OTHER

We will be using commercialized cognitive-based training programs in order to facilitate several cognitive functions. We will be targeting attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance different types of cognitive functions. Cognitive program difficulty will be adjusted automatically and continuously based on each participant's level of performance.

physical exercise training (PE group)

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.

Group Type: EXPERIMENTAL

physical exercise training

Intervention Type: OTHER

The physical exercise programs will involve balance or strength training or aerobic exercises. These may include (but not limited to) stepping, walking, dancing, ball kicking and throwing, and etc. The exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period. The exercise intensity will be progressed as the participants improve their performance throughout practice. To prevent exercise-induced injuries, vital signs and the Borg Perceived Exertion Scale will be monitored and recorded in each training session. If the training therapist observed that the exercise may be too intense for the participants, he/she will immediately reduce the training intensity.

sequential training (SEQ group)

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.

Group Type: EXPERIMENTAL

cognitive training

Intervention Type: OTHER

We will be using commercialized cognitive-based training programs in order to facilitate several cognitive functions. We will be targeting attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance different types of cognitive functions. Cognitive program difficulty will be adjusted automatically and continuously based on each participant's level of performance.

physical exercise training

Intervention Type: OTHER

The physical exercise programs will involve balance or strength training or aerobic exercises. These may include (but not limited to) stepping, walking, dancing, ball kicking and throwing, and etc. The exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period. The exercise intensity will be progressed as the participants improve their performance throughout practice. To prevent exercise-induced injuries, vital signs and the Borg Perceived Exertion Scale will be monitored and recorded in each training session. If the training therapist observed that the exercise may be too intense for the participants, he/she will immediately reduce the training intensity.

dual-task training (Dual group)

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.

Group Type: EXPERIMENTAL

cognitive training

Intervention Type: OTHER

We will be using commercialized cognitive-based training programs in order to facilitate several cognitive functions. We will be targeting attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance different types of cognitive functions. Cognitive program difficulty will be adjusted automatically and continuously based on each participant's level of performance.

physical exercise training

Intervention Type: OTHER

The physical exercise programs will involve balance or strength training or aerobic exercises. These may include (but not limited to) stepping, walking, dancing, ball kicking and throwing, and etc. The exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period. The exercise intensity will be progressed as the participants improve their performance throughout practice. To prevent exercise-induced injuries, vital signs and the Borg Perceived Exertion Scale will be monitored and recorded in each training session. If the training therapist observed that the exercise may be too intense for the participants, he/she will immediately reduce the training intensity.

Interventions

cognitive training

We will be using commercialized cognitive-based training programs in order to facilitate several cognitive functions. We will be targeting attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance different types of cognitive functions. Cognitive program difficulty will be adjusted automatically and continuously based on each participant's level of performance.

Intervention Type: OTHER

physical exercise training

The physical exercise programs will involve balance or strength training or aerobic exercises. These may include (but not limited to) stepping, walking, dancing, ball kicking and throwing, and etc. The exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period. The exercise intensity will be progressed as the participants improve their performance throughout practice. To prevent exercise-induced injuries, vital signs and the Borg Perceived Exertion Scale will be monitored and recorded in each training session. If the training therapist observed that the exercise may be too intense for the participants, he/she will immediately reduce the training intensity.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ching-yi Wu, ScD

Role: CONTACT

cywu@mail.cgu.edu.tw

#886-3-2118800 ext. 5761

Facility Contacts

Ching-yi Wu, ScD

Role: primary

cywu@mail.cgu.edu.tw

+886-3-2118800 ext. 5761

Other Identifiers

201600262A3

Identifier Type: -

Identifier Source: org_study_id