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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930263
• Other study ID #: 201808096RINA
• Status: Completed
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: June 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Aerobic exercise
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
• control group
control group received routine care and a manual on healthy living

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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