Trial Outcomes & Findings for Walking Exercise on Memory, Subjective Cognitive Complaint, and Brain-derived Neurotrophic Factor for Hypertension (NCT NCT04930263)
NCT ID: NCT04930263
Last Updated: 2021-12-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
outcome measure at 24th week
Results posted on
2021-12-13
Participant Flow
A total of eighty women with hypertension were screened in the study. Ten women refused and four women did not have the time. Only 66 were enrolled
Participant milestones
| Measure |
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
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.
|
Control Group
Given routine care and life health manual for the participants.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
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
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.
|
Control Group
Given routine care and life health manual for the participants.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Aerobic Exercise
n=30 Participants
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
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.
|
Control Group
n=28 Participants
Given routine care and life health manual for the participants.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 6.5 • n=30 Participants
|
69.8 years
STANDARD_DEVIATION 7.6 • n=28 Participants
|
69.5 years
STANDARD_DEVIATION 7.0 • n=58 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=30 Participants
|
28 Participants
n=28 Participants
|
58 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=58 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
30 participants
n=30 Participants
|
28 participants
n=28 Participants
|
58 participants
n=58 Participants
|
|
The Montreal Cognitive Assessment
|
26.8 units on a scale
STANDARD_DEVIATION 1.9 • n=30 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 1.8 • n=28 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 1.9 • n=58 Participants
|
PRIMARY outcome
Timeframe: outcome measure at 24th weekPopulation: The Hopkins Verbal Learning Test , Post-test
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 measures
| Measure |
Aerobic Exercise
n=30 Participants
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
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.
|
Control Group
n=28 Participants
Given routine care and life health manual for the participants.
|
|---|---|---|
|
Memory Function
The Hopkins Verbal Learning Test total Recall
|
25.5 score on a scale
Standard Deviation 4.5
|
24.0 score on a scale
Standard Deviation 4.5
|
|
Memory Function
The Hopkins Verbal Learning Test, delayed recall
|
9.7 score on a scale
Standard Deviation 2.4
|
9.0 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: outcome measure at 24th weekBlood sample will be collected. Plasma concentrate of Brain-derived neurotrophic factor will be analyzed by enzyme-linked immunosorbent assay
Outcome measures
| Measure |
Aerobic Exercise
n=30 Participants
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
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.
|
Control Group
n=28 Participants
Given routine care and life health manual for the participants.
|
|---|---|---|
|
Brain-derived Neurotrophic Factor
|
206.0 pg/ml
Standard Deviation 52.7
|
176.2 pg/ml
Standard Deviation 72.2
|
SECONDARY outcome
Timeframe: outcome measure at 24th weekCognitive 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 measures
| Measure |
Aerobic Exercise
n=30 Participants
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
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.
|
Control Group
n=28 Participants
Given routine care and life health manual for the participants.
|
|---|---|---|
|
Subjective Cognitive Complaints
|
18.9 score on a scale
Standard Deviation 11.2
|
20.5 score on a scale
Standard Deviation 13.1
|
Adverse Events
Aerobic Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mrs Cheng-Chen Chou
National Yang Ming Chiao Tung University
Phone: 28267176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place