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

NCT ID: NCT04930263

Last Updated: 2021-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2019-07-31

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.

Conditions

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Hypertension

Keywords

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Walking exercise Memory Hypertension Brain-derived neurotrophic factor Subjective Cognitive Complaint Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

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

Given routine care and life health manual for the participants.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type BEHAVIORAL

control group received routine care and a manual on healthy living

Interventions

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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

Intervention Type BEHAVIORAL

control group

control group received routine care and a manual on healthy living

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng-Chen Chou

Role: PRINCIPAL_INVESTIGATOR

Nursing

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201808096RINA

Identifier Type: -

Identifier Source: org_study_id