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| Name | Class |
|---|---|
| Mons. Mazzali Foundation (Mantua, Italy) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (TR) | Experimental | A group of 80 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months. |
|
| Control group (CTRL) | No Intervention | A group of 80 patients with AD will be treated with the standard therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecological Environmental therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | PRE and POST 6 months of treatment |
| 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. | PRE and POST 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | PRE and POST 6 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Venturelli, Ph.D. | Universita di Verona | Principal Investigator |
| Federico Schena, MD; Ph.D. | Universita di Verona | Study Director |
| Nicola Smania, MD | Universita di Verona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mons. Mazzali Foundation | Mantua Italy | Mantua | 46100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19893184 | Background | Calkins MP. Evidence-based long term care design. NeuroRehabilitation. 2009;25(3):145-54. doi: 10.3233/NRE-2009-0512. | |
| 19531775 | Background | Friedrich MJ. Therapeutic environmental design aims to help patients with Alzheimer disease. JAMA. 2009 Jun 17;301(23):2430. doi: 10.1001/jama.2009.809. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group (CTRL) | A group of 81 patients with AD were treated with the standard therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | PRE and POST 6 months of treatment |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group (TR) | A group of 82 patients with AD will perform 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Massimo Venturelli - PI | University of Verona | +39 02503 14648 | massimo.venturelli@univr.it |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D001523 | Mental Disorders |
| D060825 | Cognitive Dysfunction |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
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| Systolic Blood Pressure (mmHg) |
Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. |
| PRE and POST 6 months of treatment |
| Diastolic Blood Pressure (mmHg) | Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. | PRE and POST 6 months of treatment |
| Blood Glucose (mg/dl) | A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques. | PRE and POST 6 months of treatment |
| Blood Cholesterol HDL (mg/dl) | A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques. | PRE and POST 6 months of treatment |
| Blood Cholesterol LDL (mg/dl) | A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques. | PRE and POST 6 months of treatment |
| 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. | PRE and POST 6 months of treatment |
| 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. | PRE and POST 6 months of treatment |
| 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. | PRE and POST 6 months of treatment |
| 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 |
| 22707959 | Background | Detweiler MB, Sharma T, Detweiler JG, Murphy PF, Lane S, Carman J, Chudhary AS, Halling MH, Kim KY. What is the evidence to support the use of therapeutic gardens for the elderly? Psychiatry Investig. 2012 Jun;9(2):100-10. doi: 10.4306/pi.2012.9.2.100. Epub 2012 May 22. |
| 18276956 | Background | Detweiler MB, Murphy PF, Myers LC, Kim KY. Does a wander garden influence inappropriate behaviors in dementia residents? Am J Alzheimers Dis Other Demen. 2008 Feb-Mar;23(1):31-45. doi: 10.1177/1533317507309799. |
| 20150654 | Background | Smith R, Mathews RM, Gresham M. Pre- and postoccupancy evaluation of new dementia care cottages. Am J Alzheimers Dis Other Demen. 2010 May;25(3):265-75. doi: 10.1177/1533317509357735. Epub 2010 Feb 11. |
| 19366885 | Background | Detweiler MB, Murphy PF, Kim KY, Myers LC, Ashai A. Scheduled medications and falls in dementia patients utilizing a wander garden. Am J Alzheimers Dis Other Demen. 2009 Aug-Sep;24(4):322-32. doi: 10.1177/1533317509334036. Epub 2009 Apr 14. |
| 15359562 | Background | Heath Y. Evaluating the effect of therapeutic gardens. Am J Alzheimers Dis Other Demen. 2004 Jul-Aug;19(4):239-42. doi: 10.1177/153331750401900410. |
| 3942940 | Background | Rodenburg M. Special facilities for patients with Alzheimer's disease. CMAJ. 1986 Feb 15;134(4):315-6. No abstract available. |
| 23207487 | Background | Rivasseau Jonveaux T, Batt M, Fescharek R, Benetos A, Trognon A, Bah Chuzeville S, Pop A, Jacob C, Yzoard M, Demarche L, Soulon L, Malerba G, Bouvel B. Healing gardens and cognitive behavioral units in the management of Alzheimer's disease patients: the Nancy experience. J Alzheimers Dis. 2013;34(1):325-38. doi: 10.3233/JAD-121657. |
| 24128125 | Background | Gonzalez MT, Kirkevold M. Benefits of sensory garden and horticultural activities in dementia care: a modified scoping review. J Clin Nurs. 2014 Oct;23(19-20):2698-715. doi: 10.1111/jocn.12388. Epub 2013 Oct 15. |
| 19893188 | Background | York SL. Residential design and outdoor area accessibility. NeuroRehabilitation. 2009;25(3):201-8. doi: 10.3233/NRE-2009-0516. |
| 24219216 | Background | Venturelli M, Scarsini R, Muti E, Salvagno GL, Schena F. Sundowning syndrome and hypothalamic-pituitary-adrenal axis dysregulation in individuals with Alzheimer's disease: is there an association? J Am Geriatr Soc. 2013 Nov;61(11):2055-6. doi: 10.1111/jgs.12491. No abstract available. |
| 22984089 | Background | Venturelli M, Magalini A, Scarsini R, Schena F. From Alzheimer's disease retrogenesis: a new care strategy for patients with advanced dementia. Am J Alzheimers Dis Other Demen. 2012 Nov;27(7):483-9. doi: 10.1177/1533317512459794. Epub 2012 Sep 13. |
| 21852281 | Background | Venturelli M, Scarsini R, Schena F. Six-month walking program changes cognitive and ADL performance in patients with Alzheimer. Am J Alzheimers Dis Other Demen. 2011 Aug;26(5):381-8. doi: 10.1177/1533317511418956. Epub 2011 Aug 17. |
| 20209421 | Background | Venturelli M, Lanza M, Muti E, Schena F. Positive effects of physical training in activity of daily living-dependent older adults. Exp Aging Res. 2010 Apr;36(2):190-205. doi: 10.1080/03610731003613771. |
| BG001 |
| Control Group (CTRL) |
A group of 81 patients with AD were treated with the standard therapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A group of 81 patients with AD were treated with the standard therapy. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | PRE and POST 6 months of treatment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | kg | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Systolic Blood Pressure (mmHg) | Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. | Posted | Mean | Standard Deviation | (mmHg) | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Diastolic Blood Pressure (mmHg) | Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique. | Posted | Mean | Standard Deviation | (mmHg) | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Blood Glucose (mg/dl) | A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques. | Posted | Mean | Standard Deviation | (mg/dl) | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Blood Cholesterol HDL (mg/dl) | A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques. | Posted | Mean | Standard Deviation | (mg/dl) | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Blood Cholesterol LDL (mg/dl) | A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques. | Posted | Mean | Standard Deviation | (mg/dl) | PRE and POST 6 months of treatment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | (Kcal/day) | PRE and POST 6 months of treatment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a scale | PRE and POST 6 months of treatment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | (nmol/L) | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Number of Medications | Posted | Mean | Standard Deviation | Number of Medications | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Number of Patients Treated With Quetiapine | Posted | Number | Participants | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Number of Patients Treated With Citalopram | Posted | Number | Participants | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Number of Patients Treated With Donepezil | Posted | Number | Participants | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Number of Patients Treated With Memantine | Posted | Number | Participants | PRE and POST 6 months of treatment |
|
|
|
|
| Secondary | Number of Patients Treated With Ticlopidin | Posted | Number | Participants | PRE and POST 6 months of treatment |
|
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | Control Group (CTRL) | A group of 81 patients with AD will be treated with the standard therapy. | 0 | 81 | 0 | 81 |
Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D003072 | Cognition Disorders |
| <0.01 |
| Mean Difference (Final Values) |
| -1.94 |
| 2-Sided |
| 95 |
| -2.6 |
| -1.2 |
| Superiority or Other |
| PRE Vs POST | ANOVA | <0.01 | Mean Difference (Final Values) | 0.94 | 2-Sided | 95 | 0.28 | 1.61 | Superiority or Other |
| PRE Vs POST | ANOVA | <0.01 | Mean Difference (Final Values) | -0.84 | 2-Sided | 95 | -1.52 | -0.17 | Superiority or Other |
| = 0.9 |
| Mean Difference (Final Values) |
| -1.31 |
| 2-Sided |
| 95 |
| -4.3 |
| 1.7 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.88 | Mean Difference (Final Values) | -0.22 | 2-Sided | 95 | -3.14 | 2.69 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.89 | Mean Difference (Final Values) | -0.78 | 2-Sided | 95 | -3.73 | 2.16 | Superiority or Other |
| 0.59 |
| Mean Difference (Final Values) |
| 2.62 |
| 2-Sided |
| 95 |
| -1.60 |
| 6.90 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.34 | Mean Difference (Final Values) | -2.99 | 2-Sided | 95 | -7.15 | 1.16 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.9 | Mean Difference (Final Values) | 1.03 | 2-Sided | 95 | -3.17 | 5.23 | Superiority or Other |
| <0.01 |
| Mean Difference (Final Values) |
| 2.69 |
| 2-Sided |
| 95 |
| 0.84 |
| 4.53 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.010 | Mean Difference (Final Values) | -2.14 | 2-Sided | 95 | -3.94 | -0.34 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.84 | Mean Difference (Final Values) | 0.18 | 2-Sided | 95 | -1.64 | 2.00 | Superiority or Other |
| 0.7 |
| Mean Difference (Final Values) |
| 0.79 |
| 2-Sided |
| 95 |
| -0.81 |
| 2.41 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.88 | Mean Difference (Final Values) | 0.40 | 2-Sided | 95 | -1.17 | 1.98 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.95 | Mean Difference (Final Values) | -0.19 | 2-Sided | 95 | -1.78 | 1.39 | Superiority or Other |
| 0.23 |
| Mean Difference (Final Values) |
| 0.43 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.99 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.96 | Mean Difference (Final Values) | -0.10 | 2-Sided | 95 | -0.65 | 0.44 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.15 | Mean Difference (Final Values) | 0.46 | 2-Sided | 95 | -0.08 | 1.01 | Superiority or Other |
| 0.81 |
| Mean Difference (Final Values) |
| 0.28 |
| 2-Sided |
| 95 |
| -0.96 |
| 1.54 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.86 | Mean Difference (Final Values) | -0.48 | 2-Sided | 95 | -1.71 | 0.74 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.75 | Mean Difference (Final Values) | -0.26 | 2-Sided | 95 | -1.49 | 0.97 | Superiority or Other |
| 0.87 |
| Mean Difference (Final Values) |
| 8.36 |
| 2-Sided |
| 95 |
| -53.47 |
| 70.20 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.78 | Mean Difference (Final Values) | -29.70 | 2-Sided | 95 | -90.19 | 30.78 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.84 | Mean Difference (Final Values) | -6.60 | 2-Sided | 95 | -67.7 | 54.5 | Superiority or Other |
| 0.82 |
| Mean Difference (Final Values) |
| -1.25 |
| 2-Sided |
| 95 |
| -5.54 |
| 3.04 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.59 | Mean Difference (Final Values) | 0.63 | 2-Sided | 95 | -3.57 | 4.82 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.69 | Mean Difference (Final Values) | -1.04 | 2-Sided | 95 | -5.28 | 3.19 | Superiority or Other |
| <0.01 |
| Mean Difference (Final Values) |
| 2.86 |
| 2-Sided |
| 95 |
| 1.96 |
| 3.76 |
| Superiority or Other |
| PRE Vs POST | ANOVA | <0.01 | Mean Difference (Final Values) | -2.92 | 2-Sided | 95 | -3.80 | -2.04 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.88 | Mean Difference (Final Values) | -0.28 | 2-Sided | 95 | -1.17 | 0.59 | Superiority or Other |
| 0.005 |
| Mean Difference (Final Values) |
| 0.72 |
| 2-Sided |
| 95 |
| 0.15 |
| 1.29 |
| Superiority or Other |
| PRE Vs POST | ANOVA | 0.013 | Mean Difference (Final Values) | -0.65 | 2-Sided | 95 | -1.21 | -0.09 | Superiority or Other |
| PRE Vs POST | ANOVA | 0.87 | Mean Difference (Final Values) | 0.24 | 2-Sided | 95 | -0.31 | 0.81 | Superiority or Other |