Clinical trial NCT04930263: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Walking exercise
Memory
Hypertension
Brain-derived neurotrophic factor
Subjective Cognitive Complaint
Women
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 66
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. aged 60-80 years old,
2. a diagnosed of hypertension ≥ 6 months
3. self-reporting the signs of memory or thinking skills problems

Exclusion Criteria:

1. probable cognitive impairment as assessed by Montreal Cognitive Assessment ( \< 24 points),
2. significant conditions limiting walking ability (e.g. musculoskeletal problems, visual impairment, etc.),
3. already participating in 30 minutes or more of moderate-intensity exercise five times a week
4. a history of severe cardiovascular disease,
5. a history of neurologic or psychiatric disorder such as stroke, head injury dementia, Parkinson disease, and depression.

Primary outcomes:
measure: Memory Function
timeFrame: outcome measure at 24th week
Secondary outcomes:
measure: Brain-derived Neurotrophic Factor
timeFrame: outcome measure at 24th week
measure: Subjective Cognitive Complaints
timeFrame: outcome measure at 24th week
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Nursing
name: Cheng-Chen Chou
role: PRINCIPAL_INVESTIGATOR
References: