Mild Cognitive Impairment Clinical Trial
Official title:
Effects of E-health Enhanced Motor-cognitive Training on Cognitive Functions, Physical Frailty and Physical Functions of Accident and Emergency Department Discharged Community-dwelling Older Adults With Cognitive Frailty: A Pilot Trial
The goal of this pilot randomized controlled trial is to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2) physical functions and (3) frailty status. Participants in the intervention group will receive three-90-minute weekly physical and cognitive training for 12 weeks, facilitated with persuasive technology on smartphones, in addition to the usual care. The control group will receive the usual care. Researchers will explore the feasibility and compare the changes of outcomes between two groups.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Aged 60 years old or above; - discharged from the AED; - Cantonese speaking; - have a smartphone and have experience in using the smartphone for at least six months; - with cognitive frailty, the coexistence of mild cognitive impairment (MCI) and physical frailty, without being diagnosed as dementia. Exclusion Criteria: - unable to make consent, - unable to communicate due to language barrier or visual impairment or uncorrectable hearing impairment, - old aged home residents, - already participated in other interventional studies, - participate in any geriatric program and training, or - impaired mobility |
Country | Name | City | State |
---|---|---|---|
Hong Kong | School of Nursing, The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University | Hospital Authority, Hong Kong, Tung Wah College |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rate | One of the feasibility outcomes. It is the overall recruitment rate, which will be calculated by dividing the number of recruited and randomized, by the total invited eligible potential participants. It will range from 0 to 100%. | At baseline | |
Primary | Retention rate | One of the feasibility outcomes. It is calculated by dividing the number of randomised participants retained and assessed with valid primary outcome data at the end of the project, by the recruited participants. It will range from 0 to 100%. | At the 12th - 14th week (post-intervention) | |
Primary | Adverse events | A feasibility indicators, which is defined as an undesired effect of the intervention. Any adverse events reported by the participants will be documented and reported. | Continuous monitoring throughout the 12 weeks of intervention | |
Secondary | Global cognition | It will be assessed with the Hong Kong version Montreal of Cognitive Assessment. The total score of the instrument ranges from 0 - 30. Higher score indicates better cognitive functions. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Memory | It will be measured with Fuld Object Memory Evaluation. It consists of three subscores, namely the total storage, total retrieval and delayed recall with the highest possible scores of 50, 50, and 10 respectively. Higher the scores indicate better cognitive functions. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Visual attention and task switching | It will be measured with the Trail Making Test (TMT), which consists of two parts: TMT-A and TMT-B. Shorter the time used indicates better cognitive functions. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Mobility | It will be measured with the Time-up-and-Go test. It represents the total time needed for the participants to stand and walk for 3 meters, turn around and walk back to the chair and sit down. Shorter the time used indicates better monility. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Gait speed | The time used for the 6-meter walk, shorter the time used indicates better gait speed. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Leg strength and endurance | It will be assessed with the Chair Stand Test. The participants will be required to stand up repeatedly from a chair for 30 seconds. The higher number of stands a person can complete in 30 seconds, indicates a better leg strength and endurance. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Physical activity | It will be measured with the Physical Activity Scale for the Elderly, which quantify the amount of daily physical activity. The total score ranges from 0 to 793, with a higher score indicates a larger amount of physical activity. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Hand-grip strength | It will be measured with a handgrip dyanometer. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Strength of upper extremities | It will be measured with the Arm-Curl Test. The number of bicep curls in 30 seconds while holding a hand weight. | At baseline, and the 12th - 14th week (post intervention) | |
Secondary | Actigraph data | Data will be collected with a wrist worn Actigraph GT3X+ device. | Throughout the 12 weeks intervention period. | |
Secondary | Frailty status | The Fried Frailty Index will be used to measure the frailty status. The total score ranges from 0 to five. Higher score indicates a higher frailty level. Score 0, 1-2, and 3-5 correspond to robust, pre-frail, and frail respectively. | At baseline, and the 12th - 14th week (post intervention) |
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