Alzheimer Disease, Behavioral Disorders, Cognitive Impairment
Conditions
Keywords
Neurological Disorders, Non Pharmacological Treatment, Ecological Therapy
Brief summary
Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of disability with elevated social costs. Alternative solutions to the standard pharmacological therapies have been studied in order to reduce the use of medications that frequently generates side effects and worsen patients' quality of life. A recent alternative treatment for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this approach is still mater of debate. Therefore, the aim of this trial will be to analyze the effects of EET, in people with severe AD.
Detailed description
Since Homo sapiens evolved in a natural environment, an intrinsic physiologic and psychological positive reaction to nature has been developed. Accordingly, emerging literature highlights the positive effect of therapeutic gardens, as environmental ecological therapy (EET) on the reduction of behavioral disorders (BD) and the preservation of cognitive functions in patients with Alzheimer's disease (AD). Despite these promising preliminary studies, limited data are available on the effectiveness of EET in individuals with advanced AD. Therefore, the aim of the current trial will be to evaluate the effectiveness of EET on AD symptoms in patients with advanced AD. Participants with advanced AD will be selected from among residents of the Alzheimer's care units of the Mons. Mazzali Foundation (Mantua, Italy). Selected participants will be randomly assigned to a treatment group (TR), or to a control group (CTRL). Participants assigned to TR group will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months. Individuals assigned to the CTRL group will be treated with a standard therapy.
Interventions
OTHEREcological Environmental therapy
The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD.
Sponsors
Mons. Mazzali Foundation (Mantua, Italy)
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Person with Alzheimer's disease.
Exclusion criteria
* Bedridden patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluations of Behavioral Disorders | PRE and POST 6 months of treatment | Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome. |
| Evaluation of Cognitive Status (Score 0-30) | PRE and POST 6 months of treatment | Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure (mmHg) | PRE and POST 6 months of treatment | Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. |
| Blood Glucose (mg/dl) | PRE and POST 6 months of treatment | A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques. |
| Blood Cholesterol HDL (mg/dl) | PRE and POST 6 months of treatment | A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques. |
| Blood Cholesterol LDL (mg/dl) | PRE and POST 6 months of treatment | A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques. |
| Daily Energy Expenditure (Kcal/Day) | PRE and POST 6 months of treatment | Daily energy expenditure was measured with an Actiheart device (CamNtech, Cambridge, UK) allowing heart rate and acceleration data to be simultaneously recorded for 24 h/day for 7 consecutive days. |
| Evaluation of Activity of Daily Life | PRE and POST 6 months of treatment | Independence and level of activities of daily life (ADL) were evaluated with the Barthel index. Levels of ADL was measured by observing each resident's daily activities (eating, bathing, grooming, dressing, transfers from bed to chair, mobility on level planes, stairs, and getting on/off the toilet). The total score of the Barthel index is 0-100, and higher values represent a better outcome. |
| Body Composition (Kilograms of Fat Free Mass) | PRE and POST 6 months of treatment | Body mass and skin-fold measurements were measured three times a day by the same experienced operator. The average value of the three measurements was calculated. Kilograms of fat free mass was estimated using a validated equation. |
| Number of Medications | PRE and POST 6 months of treatment | — |
| Number of Patients Treated With Quetiapine | PRE and POST 6 months of treatment | — |
| Number of Patients Treated With Citalopram | PRE and POST 6 months of treatment | — |
| Number of Patients Treated With Donepezil | PRE and POST 6 months of treatment | — |
| Number of Patients Treated With Memantine | PRE and POST 6 months of treatment | — |
| Number of Patients Treated With Ticlopidin | PRE and POST 6 months of treatment | — |
| Salivary Cortisol (Nmol/l) | PRE and POST 6 months of treatment | Levels of cortisol was measured via saliva samples using plain Sarstedt Salivette collection devices (Nümbrecht, Germany). Samples will be collected at 6.30 AM, 11.30 AM, and 6.30 PM. Immediately after collecting the saliva samples, were centrifuged for 2 min at 1,000 rpm. Purified saliva was stored in a freezer at -20 °C, and subsequently analyzed. Cortisol levels was determined by a time-resolved immunoassay with fluorometric detection. |
| Systolic Blood Pressure (mmHg) | PRE and POST 6 months of treatment | Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group (TR) A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.
Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD. | 82 |
| Control Group (CTRL) A group of 81 patients with AD were treated with the standard therapy. | 81 |
| Total | 163 |
Baseline characteristics
| Characteristic | Experimental Group (TR) | Control Group (CTRL) | Total |
|---|---|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 4 | 78 years STANDARD_DEVIATION 5 | 77 years STANDARD_DEVIATION 7 |
| Region of Enrollment Italy | 82 participants | 81 participants | 163 participants |
| Sex: Female, Male Female | 60 Participants | 61 Participants | 121 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 82 | 0 / 81 |
| serious Total, serious adverse events | 0 / 82 | 0 / 81 |
Outcome results
Primary
Evaluation of Cognitive Status (Score 0-30)
Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Evaluation of Cognitive Status (Score 0-30) | PRE | 13.2 Scores on a scale | Standard Deviation 1.7 |
| Experimental Group (TR) | Evaluation of Cognitive Status (Score 0-30) | POST | 14.1 Scores on a scale | Standard Deviation 1.6 |
| Control Group (CTRL) | Evaluation of Cognitive Status (Score 0-30) | PRE | 13.1 Scores on a scale | Standard Deviation 1.5 |
| Control Group (CTRL) | Evaluation of Cognitive Status (Score 0-30) | POST | 12.2 Scores on a scale | Standard Deviation 1.5 |
Comparison: Baselinep-value: 195% CI: [-0.8, 0.5]ANOVA
Comparison: After the treatmentp-value: <0.0195% CI: [-2.6, -1.2]ANOVA
Comparison: PRE Vs POSTp-value: <0.0195% CI: [0.28, 1.61]ANOVA
Comparison: PRE Vs POSTp-value: <0.0195% CI: [-1.52, -0.17]ANOVA
Primary
Evaluations of Behavioral Disorders
Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Evaluations of Behavioral Disorders | PRE | 68 Scores on a scale | Standard Deviation 19 |
| Experimental Group (TR) | Evaluations of Behavioral Disorders | POST | 36 Scores on a scale | Standard Deviation 11 |
| Control Group (CTRL) | Evaluations of Behavioral Disorders | POST | 69 Scores on a scale | Standard Deviation 16 |
| Control Group (CTRL) | Evaluations of Behavioral Disorders | PRE | 66 Scores on a scale | Standard Deviation 16 |
Comparison: Baselinep-value: 195% CI: [-7.9, 5.4]ANOVA
Comparison: After the treatmentp-value: <0.0195% CI: [26.4, 40.2]ANOVA
Comparison: PRE Vs POSTp-value: <0.0195% CI: [-38.2, -24.8]ANOVA
Comparison: PRE Vs POSTp-value: 195% CI: [-3.7, 9.9]ANOVA
Secondary
Blood Cholesterol HDL (mg/dl)
A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Blood Cholesterol HDL (mg/dl) | PRE | 51.96 (mg/dl) | Standard Deviation 1.19 |
| Experimental Group (TR) | Blood Cholesterol HDL (mg/dl) | POST | 51.86 (mg/dl) | Standard Deviation 1.06 |
| Control Group (CTRL) | Blood Cholesterol HDL (mg/dl) | PRE | 51.83 (mg/dl) | Standard Deviation 1.41 |
| Control Group (CTRL) | Blood Cholesterol HDL (mg/dl) | POST | 52.29 (mg/dl) | Standard Deviation 1.46 |
Comparison: Baselinep-value: 0.9595% CI: [-0.67, 0.4]ANOVA
Comparison: After the treatmentp-value: 0.2395% CI: [-0.12, 0.99]ANOVA
Comparison: PRE Vs POSTp-value: 0.9695% CI: [-0.65, 0.44]ANOVA
Comparison: PRE Vs POSTp-value: 0.1595% CI: [-0.08, 1.01]ANOVA
Secondary
Blood Cholesterol LDL (mg/dl)
A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Blood Cholesterol LDL (mg/dl) | PRE | 98.34 (mg/dl) | Standard Deviation 3.04 |
| Experimental Group (TR) | Blood Cholesterol LDL (mg/dl) | POST | 97.86 (mg/dl) | Standard Deviation 3.19 |
| Control Group (CTRL) | Blood Cholesterol LDL (mg/dl) | PRE | 98.41 (mg/dl) | Standard Deviation 2.68 |
| Control Group (CTRL) | Blood Cholesterol LDL (mg/dl) | POST | 98.15 (mg/dl) | Standard Deviation 2.69 |
Comparison: Baselinep-value: 0.8495% CI: [-1.14, 1.27]ANOVA
Comparison: After the treatmentp-value: 0.8195% CI: [-0.96, 1.54]ANOVA
Comparison: PRE Vs POSTp-value: 0.8695% CI: [-1.71, 0.74]ANOVA
Comparison: PRE Vs POSTp-value: 0.7595% CI: [-1.49, 0.97]ANOVA
Secondary
Blood Glucose (mg/dl)
A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Blood Glucose (mg/dl) | PRE | 87.01 (mg/dl) | Standard Deviation 3.25 |
| Experimental Group (TR) | Blood Glucose (mg/dl) | POST | 87.42 (mg/dl) | Standard Deviation 3.76 |
| Control Group (CTRL) | Blood Glucose (mg/dl) | PRE | 88.41 (mg/dl) | Standard Deviation 4.04 |
| Control Group (CTRL) | Blood Glucose (mg/dl) | POST | 88.21 (mg/dl) | Standard Deviation 3.89 |
Comparison: Baselinep-value: 0.1195% CI: [-0.16, 2.95]ANOVA
Comparison: After the treatmentp-value: 0.795% CI: [-0.81, 2.41]ANOVA
Comparison: PRE Vs POSTp-value: 0.8895% CI: [-1.17, 1.98]ANOVA
Comparison: PRE Vs POSTp-value: 0.9595% CI: [-1.78, 1.39]ANOVA
Secondary
Body Composition (Kilograms of Fat Free Mass)
Body mass and skin-fold measurements were measured three times a day by the same experienced operator. The average value of the three measurements was calculated. Kilograms of fat free mass was estimated using a validated equation.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Body Composition (Kilograms of Fat Free Mass) | PRE | 43.6 kg | Standard Deviation 5.9 |
| Experimental Group (TR) | Body Composition (Kilograms of Fat Free Mass) | POST | 43.4 kg | Standard Deviation 6.2 |
| Control Group (CTRL) | Body Composition (Kilograms of Fat Free Mass) | PRE | 42.8 kg | Standard Deviation 7.6 |
| Control Group (CTRL) | Body Composition (Kilograms of Fat Free Mass) | POST | 42.1 kg | Standard Deviation 7.8 |
Comparison: Baselinep-value: =0.8495% CI: [-3.6, 2.1]ANOVA
Comparison: After the treatmentp-value: =0.995% CI: [-4.3, 1.7]ANOVA
Comparison: PRE Vs POSTp-value: 0.8895% CI: [-3.14, 2.69]ANOVA
Comparison: PRE Vs POSTp-value: 0.8995% CI: [-3.73, 2.16]ANOVA
Secondary
Daily Energy Expenditure (Kcal/Day)
Daily energy expenditure was measured with an Actiheart device (CamNtech, Cambridge, UK) allowing heart rate and acceleration data to be simultaneously recorded for 24 h/day for 7 consecutive days.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Daily Energy Expenditure (Kcal/Day) | PRE | 1639 (Kcal/day) | Standard Deviation 134 |
| Experimental Group (TR) | Daily Energy Expenditure (Kcal/Day) | POST | 1609 (Kcal/day) | Standard Deviation 128 |
| Control Group (CTRL) | Daily Energy Expenditure (Kcal/Day) | PRE | 1623 (Kcal/day) | Standard Deviation 155 |
| Control Group (CTRL) | Daily Energy Expenditure (Kcal/Day) | POST | 1617 (Kcal/day) | Standard Deviation 154 |
Comparison: Baselinep-value: 0.9495% CI: [-74.4, 44.9]ANOVA
Comparison: After the treatmentp-value: 0.8795% CI: [-53.47, 70.2]ANOVA
Comparison: PRE Vs POSTp-value: 0.7895% CI: [-90.19, 30.78]ANOVA
Comparison: PRE Vs POSTp-value: 0.8495% CI: [-67.7, 54.5]ANOVA
Secondary
Diastolic Blood Pressure (mmHg)
Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Diastolic Blood Pressure (mmHg) | PRE | 81 (mmHg) | Standard Deviation 5 |
| Experimental Group (TR) | Diastolic Blood Pressure (mmHg) | POST | 78 (mmHg) | Standard Deviation 5 |
| Control Group (CTRL) | Diastolic Blood Pressure (mmHg) | PRE | 81 (mmHg) | Standard Deviation 4 |
| Control Group (CTRL) | Diastolic Blood Pressure (mmHg) | POST | 81 (mmHg) | Standard Deviation 4 |
Comparison: Baselinep-value: 0.8395% CI: [-1.41, 2.14]ANOVA
Comparison: After the treatmentp-value: <0.0195% CI: [0.84, 4.53]ANOVA
Comparison: PRE Vs POSTp-value: 0.0195% CI: [-3.94, -0.34]ANOVA
Comparison: PRE Vs POSTp-value: 0.8495% CI: [-1.64, 2]ANOVA
Secondary
Evaluation of Activity of Daily Life
Independence and level of activities of daily life (ADL) were evaluated with the Barthel index. Levels of ADL was measured by observing each resident's daily activities (eating, bathing, grooming, dressing, transfers from bed to chair, mobility on level planes, stairs, and getting on/off the toilet). The total score of the Barthel index is 0-100, and higher values represent a better outcome.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Evaluation of Activity of Daily Life | PRE | 51.87 Scores on a scale | Standard Deviation 9.55 |
| Experimental Group (TR) | Evaluation of Activity of Daily Life | POST | 52.49 Scores on a scale | Standard Deviation 11.41 |
| Control Group (CTRL) | Evaluation of Activity of Daily Life | PRE | 52.28 Scores on a scale | Standard Deviation 9.42 |
| Control Group (CTRL) | Evaluation of Activity of Daily Life | POST | 51.24 Scores on a scale | Standard Deviation 9.4 |
Comparison: Baselinep-value: 0.7495% CI: [-3.73, 4.56]ANOVA
Comparison: After the treatmentp-value: 0.8295% CI: [-5.54, 3.04]ANOVA
Comparison: PRE Vs POSTp-value: 0.5995% CI: [-3.57, 4.82]ANOVA
Comparison: PRE Vs POSTp-value: 0.6995% CI: [-5.28, 3.19]ANOVA
Secondary
Number of Medications
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Number of Medications | PRE | 3.76 Number of Medications | Standard Deviation 1.22 |
| Experimental Group (TR) | Number of Medications | POST | 3.10 Number of Medications | Standard Deviation 0.95 |
| Control Group (CTRL) | Number of Medications | PRE | 3.58 Number of Medications | Standard Deviation 1.47 |
| Control Group (CTRL) | Number of Medications | POST | 3.83 Number of Medications | Standard Deviation 1.57 |
Comparison: Baselinep-value: 0.8395% CI: [-0.72, 0.37]ANOVA
Comparison: After the treatmentp-value: 0.00595% CI: [0.15, 1.29]ANOVA
Comparison: PRE Vs POSTp-value: 0.01395% CI: [-1.21, -0.09]ANOVA
Comparison: PRE Vs POSTp-value: 0.8795% CI: [-0.31, 0.81]ANOVA
Secondary
Number of Patients Treated With Citalopram
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group (TR) | Number of Patients Treated With Citalopram | PRE | 55 Participants |
| Experimental Group (TR) | Number of Patients Treated With Citalopram | POST | 33 Participants |
| Control Group (CTRL) | Number of Patients Treated With Citalopram | PRE | 57 Participants |
| Control Group (CTRL) | Number of Patients Treated With Citalopram | POST | 53 Participants |
p-value: <0.001Chi-squared
Secondary
Number of Patients Treated With Donepezil
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group (TR) | Number of Patients Treated With Donepezil | PRE | 59 Participants |
| Experimental Group (TR) | Number of Patients Treated With Donepezil | POST | 42 Participants |
| Control Group (CTRL) | Number of Patients Treated With Donepezil | PRE | 53 Participants |
| Control Group (CTRL) | Number of Patients Treated With Donepezil | POST | 51 Participants |
p-value: 0.124Chi-squared
Secondary
Number of Patients Treated With Memantine
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group (TR) | Number of Patients Treated With Memantine | PRE | 24 Participants |
| Experimental Group (TR) | Number of Patients Treated With Memantine | POST | 23 Participants |
| Control Group (CTRL) | Number of Patients Treated With Memantine | PRE | 24 Participants |
| Control Group (CTRL) | Number of Patients Treated With Memantine | POST | 22 Participants |
p-value: 1Chi-squared
Secondary
Number of Patients Treated With Quetiapine
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group (TR) | Number of Patients Treated With Quetiapine | PRE | 41 Participants |
| Experimental Group (TR) | Number of Patients Treated With Quetiapine | POST | 35 Participants |
| Control Group (CTRL) | Number of Patients Treated With Quetiapine | PRE | 37 Participants |
| Control Group (CTRL) | Number of Patients Treated With Quetiapine | POST | 37 Participants |
p-value: =0.91Chi-squared
Secondary
Number of Patients Treated With Ticlopidin
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Group (TR) | Number of Patients Treated With Ticlopidin | POST | 40 Participants |
| Experimental Group (TR) | Number of Patients Treated With Ticlopidin | PRE | 45 Participants |
| Control Group (CTRL) | Number of Patients Treated With Ticlopidin | PRE | 39 Participants |
| Control Group (CTRL) | Number of Patients Treated With Ticlopidin | POST | 36 Participants |
p-value: 0.789Chi-squared
Secondary
Salivary Cortisol (Nmol/l)
Levels of cortisol was measured via saliva samples using plain Sarstedt Salivette collection devices (Nümbrecht, Germany). Samples will be collected at 6.30 AM, 11.30 AM, and 6.30 PM. Immediately after collecting the saliva samples, were centrifuged for 2 min at 1,000 rpm. Purified saliva was stored in a freezer at -20 °C, and subsequently analyzed. Cortisol levels was determined by a time-resolved immunoassay with fluorometric detection.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Salivary Cortisol (Nmol/l) | PRE | 10.75 (nmol/L) | Standard Deviation 1.94 |
| Experimental Group (TR) | Salivary Cortisol (Nmol/l) | POST | 7.82 (nmol/L) | Standard Deviation 2.3 |
| Control Group (CTRL) | Salivary Cortisol (Nmol/l) | PRE | 10.98 (nmol/L) | Standard Deviation 2.31 |
| Control Group (CTRL) | Salivary Cortisol (Nmol/l) | POST | 10.69 (nmol/L) | Standard Deviation 1.71 |
Comparison: Baselinep-value: 0.995% CI: [-0.64, 1.09]ANOVA
Comparison: After the treatmentp-value: <0.0195% CI: [1.96, 3.76]ANOVA
Comparison: PRE Vs POSTp-value: <0.0195% CI: [-3.8, -2.04]ANOVA
Comparison: PRE Vs POSTp-value: 0.8895% CI: [-1.17, 0.59]ANOVA
Secondary
Systolic Blood Pressure (mmHg)
Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.
Time frame: PRE and POST 6 months of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group (TR) | Systolic Blood Pressure (mmHg) | POST | 130 (mmHg) | Standard Deviation 9 |
| Experimental Group (TR) | Systolic Blood Pressure (mmHg) | PRE | 132 (mmHg) | Standard Deviation 10 |
| Control Group (CTRL) | Systolic Blood Pressure (mmHg) | POST | 132 (mmHg) | Standard Deviation 11 |
| Control Group (CTRL) | Systolic Blood Pressure (mmHg) | PRE | 131 (mmHg) | Standard Deviation 10 |
Comparison: Baselinep-value: 0.995% CI: [-5.48, 2.73]ANOVA
Comparison: After the treatmentp-value: 0.5995% CI: [-1.6, 6.9]ANOVA
Comparison: PRE Vs POSTp-value: 0.3495% CI: [-7.15, 1.16]ANOVA
Comparison: PRE Vs POSTp-value: 0.995% CI: [-3.17, 5.23]ANOVA