Walking Exercise on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor for Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of 6-month aerobic walking program on memory, subjective cognitive complaints, and brain-derived neurotrophic factor for older hypertensive women. Participants will be randomly assigned to the experimental group and the control group. The intervention group will last for 24 weeks. The outcome measurements included memory, subjective cognitive complaints, and brain-derived neurotrophic factor.

Detailed Description
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The purpose of this study is to explore an aerobic walking program on memory, subjective cognitive complaints, and brain-derived neurotrophic factor. In quantitative study with experimental design, qualified subjects will be randomly assigned to experimental or control group. Experimental subjects will perform six-month aerobic walking program and control group receive routine care. The outcome measurements included memory, subjective cognitive complaints, and brain-derived neurotrophic factor. Data will be collected at baseline, the end of the six-month intervention. Data will be analyzed using Generalized Estimation Equation evaluate the effect of the intervention program.

Official Title
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A Study of the Individualized Walking Exercise Program on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor Among Postmenopausal Hypertensive Women

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Aerobic exercise
* Behavioral: control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 60-80 years old, a diagnosed of hypertension ≥ 6 months self-reporting the signs of memory or thinking skills problems Exclusion Criteria: probable cognitive impairment as assessed by Montreal Cognitive Assessment ( < 24 points), significant conditions limiting walking ability (e.g. musculoskeletal problems, visual impairment, etc.), already participating in 30 minutes or more of moderate-intensity exercise five times a week a history of severe cardiovascular disease, a history of neurologic or psychiatric disorder such as stroke, head injury dementia, Parkinson disease, and depression.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br>Behavioral: walking exercise The intervention was 24 weeks walking intervention program with moderate-intensity, 5 sessions a week for 30 minutes per section individualized education telephone and social media counselling booklet guidance | Behavioral: Aerobic exercise<br>* The intervention was 24 weeks walking exercise program. Participants exercised frequency at 5 sessions a week for 30 minutes per section with moderate-intensity and wearable device assisted. Each session consisted of a 5 minutes warm-up, moderate-intensity walking exercises and 5 minutes cool-down. The program included individualized education, telephone and social media counselling, and booklet guidance<br>|
| Active Comparator: control group<br>Given routine care and life health manual for the participants. | Behavioral: control group<br>* control group received routine care and a manual on healthy living<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory Function | The Hopkins Verbal Learning Test was administered to measure verbal learning and memory. The score is a sum of correct responses in each of three learning trial (encoding) (possible score 0 to 36 for summed recall of trials) and a delayed recall trial (possible score 0 to 12). Higher scores mean a better memory. | outcome measure at 24th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-derived Neurotrophic Factor | Blood sample will be collected. Plasma concentrate of Brain-derived neurotrophic factor will be analyzed by enzyme-linked immunosorbent assay | outcome measure at 24th week | 
| Subjective Cognitive Complaints | Cognitive Failures Questionnaire will be used to assess subjective cognitive impairment. Each item is rated from 0 to 4 with the total score calculated as the sum of all items ranging from 0 to 100 with higher scores indicating higher levels of cognitive failures. | outcome measure at 24th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Brain-derived neurotrophic factor, Subjective Cognitive Complaint, Women, Walking exercise, Memory