A Study of the Individualized Walking Exercise Program on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor Among Postmenopausal Hypertensive Women
Phase: NA
Conditions: Hypertension
Sponsor: National Taiwan University Hospital

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Brief Title: 
Walking Exercise on Memory, Subjective Cognitive Complaint, and Brain-derived 
Neurotrophic Factor for Hypertension 
Official title: A Study of the Individualized Walking Exercise Program on Memory, Subjective 
Cognitive Complaint, and Brain-derived Neurotrophic Factor Among Postmenopausal Hypertensive 
Women   
 
Clinicaltrials: NCT04930263  
2021/11/01 
 
Study Protocol  
 
Background 
In Taiwan, the adult prevalence of hypertension increased from 20.8% in 2016 to 25% in 2018. 
More than half of women over age 60 have hypertension, and the hypertension control rate among 
Taiwanese women remains low, at 28.5% to 50% . These consequences suggest the presence of 
barriers to hypertension care, including cognitive impairment with memory decline. Memory is one 
of the most common and most frequently impaired cognitive functions in women with hypertension, 
and 25% to 55.1% of older women with hypertension reported memory impairments. One non-
pharmacological strategy that has demonstrated beneficial effects on cognitive function, specifically 
improved memory, through positively regulating plasma brain-derived neurotrophic factor, is 
physical exercise. 
Objective  
The purpose of this study was to examine the effects of an aerobic walking program on memory, 
subjective cognitive complaints, and brain-derived neurotrophic factor among older women with 
hypertension. 
Methods  
1. Study design:  

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This study employed a single-blind, randomized controlled trial. Two parallel groups with two 
assessment periods was adopted to evaluate the effects of the intervention. The inclusion criteria were 
as follows: (1) age 60 to 80 years, (2) diagnosed with hypertension for at least 6 months, (3) self-
reported indications of problems with memory or thinking skills. The exclusion criteria were as 
follows: (1) probable cognitive impairment as assessed by the Montreal Cognitive Assessment (< 24 
points); T(sai et al., 2012), (2) significant conditions limiting walking ability (e.g., musculoskeletal 
problems, visual impairment), (3) already participating in 30 minutes or more of moderate-intensity 
exercise five times a week, (4) a history of severe cardiovascular disease, and (5) a history of 
neurologic or psychiatric disorders such as stroke, head injury dementia, Parkinson’s disease, and 
depression. 
 
2. Research tools:  
Data collected for this study also included demographic, health-related, and disease-related 
information in pretest and posttest data collection. The primary outcome was memory performance, 
which was measured with the Hopkins Verbal Learning Test; the secondary outcomes were subjective 
cognitive complaints and brain-derived neurotrophic factor. Subjective cognitive complaints were 
measured with the Cognitive Failures Questionnaire, and brain-derived neurotrophic factor was 
measured through laboratory analysis of blood samples.   
 
3. Intervention approaches:  
Participants in the intervention group received a 24-week aerobic walking program with five 30-
mimute sessions per week. The aerobic walking program was delivered by a registered nurse with 

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training as an instructor in aerobic walking exercise. The instruction given to participants consisted 
of a 60-minute face-to-face individualized education session on how to perform 30 minutes of 
walking exercise five times a week, an intervention booklet, and follow-up counseling by telephone 
and social media every two weeks. 
 
Statistical Analysis Plan 
Data were analyzed using the Statistical Package for the Social Sciences (SPSS) version 25 
for Windows (Chicago, IL, USA). Descriptive statistical methods were implemented to characterize 
the characteristics of the participants and study variables. Independent t-tests, chi-square tests, and 
Fisher’s exact test were used to examine the homogeneity between the two groups. Paired t-tests were 
employed to examine the changes in each group between the pretest and 24 weeks in memory, 
subjective cognitive complaints, and brain-derived neurotrophic factor. The generalized estimating 
equation was used to evaluate whether memory, subjective cognitive complaints, and brain-derived 
neurotrophic factor were different between groups at pretest and after 24 weeks. A significance level 
of 5% was used for between-group comparisons and interaction terms.