Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

Chang Gung Medical Foundation

Status: Unknown

Conditions: Stroke Patients With Cognitive Decline

Treatments: Behavioral: Cognitive training; Behavioral: Sequential combination of aerobic exercise and cognitive training; Behavioral: Aerobic exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02550990

104-4892A3

Details and patient eligibility

About

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.

Enrollment: 75 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
2. Age range from 20 to 90 years
3. MMSE score ≥ 19
4. MoCA<26
5. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
6. Able to follow the study instruction
7. Adequate cardiopulmonary function to perform aerobic exercise
8. Able to walk with or without assistive devices

Exclusion criteria

1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
3. Current participation in another interventional trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Cognitive training group

Active Comparator group

Description:

One 60-min session of cognitive training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.

Treatment:

Behavioral: Cognitive training

Aerobic exercise training group

Active Comparator group

Description:

One 60-min session of aerobic exercise training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.

Treatment:

Behavioral: Aerobic exercise training

Sequential training group

Experimental group

Description:

One 30-min session of aerobic exercise training + one 30-min session of cognitive training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.

Treatment:

Behavioral: Sequential combination of aerobic exercise and cognitive training