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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Aerobic exercise; Behavioral: control group

• Registration Number: NCT04930263
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2018-11-09
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-18
• Results First Submitted: 2021-10-03
• Results First Submitted QC: 2021-11-07
• Last Update Submitted: 2021-11-07
• Results First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic exercise	Aerobic exercise	Behavioral: walking exercise 1. The intervention was 24 weeks walking intervention program with moderate-intensity, 5 sessions a week for 30 minutes per section 2. individualized education 3. telephone and social media counselling 4. booklet guidance
control group	control group	Given routine care and life health manual for the participants.

Primary Outcome Measures

Name	Time	Method
Memory Function	outcome measure at 24th week	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.

Secondary Outcome Measures

Name	Time	Method
Subjective Cognitive Complaints	outcome measure at 24th week	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.
Brain-derived Neurotrophic Factor	outcome measure at 24th week	Blood sample will be collected. Plasma concentrate of Brain-derived neurotrophic factor will be analyzed by enzyme-linked immunosorbent assay

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei city, Taiwan