HypertensionNCT04930263
Walking Exercise on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor for Hypertension
A study testing Aerobic exercise in people with Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Nov 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60-80 years old,
- a diagnosed of hypertension ≥ 6 months
- self-reporting the signs of memory or thinking skills problems
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Individualized Walking Exercise Program on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor Among Postmenopausal Hypertensive Women
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Aerobic exercise, control group
- Keywords
- Walking exercise, Memory, Hypertension, Brain-derived neurotrophic factor, Subjective Cognitive Complaint, Women
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
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 groupBehavioural
control group received routine care and a manual on healthy living
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Aerobic exercise |
| control group | Active comparator | Given routine care and life health manual for the participants. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: outcome measure at 24th week
Secondary outcomes (2)
Brain-derived Neurotrophic Factor
Blood sample will be collected. Plasma concentrate of Brain-derived neurotrophic factor will be analyzed by enzyme-linked immunosorbent assay
Measured: outcome measure at 24th week
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.
Measured: outcome measure at 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start9 Nov 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Chen Chou, Principal investigator, Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930263
- Sponsor's protocol ID
- 201808096RINA
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 13 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Individualized Walking Exercise Program on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor Among Postmenopausal Hypertensive Women
- ClinicalTrials.gov ID
- NCT04930263
- Acronym / sponsor ID
- 201808096RINA
- Conditions
- Hypertension
- Keywords
- Walking exercise, Memory, Hypertension, Brain-derived neurotrophic factor, Subjective Cognitive Complaint, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 13 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exerciseBehavioral: 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 | Active comparator | Behavioral: control groupGiven routine care and life health manual for the participants. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 60-80 years old,
- a diagnosed of hypertension ≥ 6 months
- self-reporting the signs of memory or thinking skills problems
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseThe 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 | Behavioural | Aerobic exercise |
| control groupcontrol group received routine care and a manual on healthy living | Behavioural | control group |
Primary outcome
Memory Function
Time frame: 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.
2 secondary outcomes
Brain-derived Neurotrophic Factor
Time frame: outcome measure at 24th week
Subjective Cognitive Complaints
Time frame: outcome measure at 24th week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Chen Chou principal investigator
Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory Function (time frame: outcome measure at 24th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.