NCT04930263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 13, 2021

Completed
Last Updated

December 13, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 14, 2021

Results QC Date

October 3, 2021

Last Update Submit

November 7, 2021

Conditions

Keywords

Walking exerciseMemoryHypertensionBrain-derived neurotrophic factorSubjective Cognitive ComplaintWomen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Brain-derived Neurotrophic Factor

    outcome measure at 24th week

  • Subjective Cognitive Complaints

    outcome measure at 24th week

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

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

Behavioral: Aerobic exercise

control group

ACTIVE COMPARATOR

Given routine care and life health manual for the participants.

Behavioral: control group

Interventions

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

Aerobic exercise
control groupBEHAVIORAL

control group received routine care and a manual on healthy living

control group

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparticipant eligibility is based on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

ExerciseControl Groups

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Mrs Cheng-Chen Chou
Organization
National Yang Ming Chiao Tung University

Study Officials

  • Cheng-Chen Chou

    Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 18, 2021

Study Start

November 9, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

December 13, 2021

Results First Posted

December 13, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations