Hypertension
Conditions
Keywords
Walking exercise, Memory, Hypertension, Brain-derived neurotrophic factor, Subjective Cognitive Complaint, Women
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.
Interventions
BEHAVIORALAerobic 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
BEHAVIORALcontrol group
control group received routine care and a manual on healthy living
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
We conduct a single-blinded, randomized controlled study. Sixty-six participants are randomly assigned to the experimental group and the control group.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Taiwan
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Control Group Given routine care and life health manual for the participants. | 28 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Aerobic Exercise | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 6.5 | 69.5 years STANDARD_DEVIATION 7 | 69.8 years STANDARD_DEVIATION 7.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Taiwan | 30 participants | 58 participants | 28 participants |
| Sex: Female, Male Female | 30 Participants | 58 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| The Montreal Cognitive Assessment | 26.8 units on a scale STANDARD_DEVIATION 1.9 | 26.8 units on a scale STANDARD_DEVIATION 1.9 | 26.8 units on a scale STANDARD_DEVIATION 1.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
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.
Time frame: outcome measure at 24th week
Population: The Hopkins Verbal Learning Test , Post-test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Exercise | Memory Function | The Hopkins Verbal Learning Test total Recall | 25.5 score on a scale | Standard Deviation 4.5 |
| Aerobic Exercise | Memory Function | The Hopkins Verbal Learning Test, delayed recall | 9.7 score on a scale | Standard Deviation 2.4 |
| Control Group | Memory Function | The Hopkins Verbal Learning Test total Recall | 24.0 score on a scale | Standard Deviation 4.5 |
| Control Group | Memory Function | The Hopkins Verbal Learning Test, delayed recall | 9.0 score on a scale | Standard Deviation 2.1 |
Secondary
Brain-derived Neurotrophic Factor
Blood sample will be collected. Plasma concentrate of Brain-derived neurotrophic factor will be analyzed by enzyme-linked immunosorbent assay
Time frame: outcome measure at 24th week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Brain-derived Neurotrophic Factor | 206.0 pg/ml | Standard Deviation 52.7 |
| Control Group | Brain-derived Neurotrophic Factor | 176.2 pg/ml | Standard Deviation 72.2 |
Secondary
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.
Time frame: outcome measure at 24th week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aerobic Exercise | Subjective Cognitive Complaints | 18.9 score on a scale | Standard Deviation 11.2 |
| Control Group | Subjective Cognitive Complaints | 20.5 score on a scale | Standard Deviation 13.1 |