Back to resultsThe Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients (GPR)
Primary Purpose
Alzheimer's Type Dementia, Cognitive Decline, Postural; Strain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GPR Intervention Research group
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Type Dementia
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease
- Older than 40 years of age
- Male and female
- Intellectual disability
- Cognitive impairment
- Able to do daily activities on his own
- No presence of any other neurological and psychological disease
- No presence of brain tumors
Exclusion Criteria:
- No presence of Alzheimer's Disease
- Under 40 years old
- Presence of brain tumors
- Neurological patients
- Presence of psychiatric disease
- Depression symptoms
- Presence of neuromuscular disease
- Ictus
- Aggressive patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GPR Intervention Research group
Control Group
Arm Description
A total of 135 subjects with AD in the mild or moderate phase participated in the study from which 90 pertain to research group.The intervention implemented to the patients with AD was the Global Postural therapy which lasted about 30-40 min in repeated sessions of 2 meetings per week by making 48 sessions in total during a six month period.
45 subjects of the study belongs to the control group which has not received the same treatment .
Outcomes
Primary Outcome Measures
Cognitive Abilities Measurement
The therapeutist provides the Mini Mental State Examination (MMSE) scale records. The evaluation consits in a 0-30 points-scale. Lower scores imply the severity of dementia.
Secondary Outcome Measures
Quality of Life in Alzheimer's disease (QoL-AD) Questionnaire
The therapeutist measures in the begining and in the end of the study the quality of life in patients with Alzheimer's disease (QoL-AD). This questionnaire consists in 13 elements referring to the perception that patients have concerning various aspects of their life: mood, health, cognition, environment and functional capacity. The range of scores is 13-52, were higher scores indicate a better life quality.
Geriatric Depression Scale (GDS) Questionnaire
The version of 15 articles was used, which given its length can be validly and reliably resolved by patients themselves in the quality of a self-report questionnaire aiming to investigate the possible presence of depressive symptoms.
Barthel Index (BI)
This scale is used by therapist to measure the performance in the basic activities of daily life of AD patients. The maximum score used is 100 points and refers to the patient's independence in all basic daily living activities.
Neuropsychiatric Inventory (NPI)
This test includes 12 symptoms scored according to the phenomenon severity and frequency. It is a helpful instrument for the therapist because of specifically designed for the assessment of psycho-behavioral disorders in individuals with cognitive impairment.
Tinetti Scale (TS)
The therapist used the equilibrium sub-scale, which consists in 7 elements and has a score between 0 and 13. Highest scores indicate a better balance.
Full Information
NCT ID
NCT03732053
First Posted
April 17, 2018
Last Updated
November 15, 2019
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT03732053
Brief Title
The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients
Acronym
GPR
Official Title
The Effectiveness of Physical Rehabilitation in the Enhancement of Proprioceptive and Cognitive Aspects on Alzheimer Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
March 10, 2017 (Actual)
Study Completion Date
July 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study is developed on an experimental design with randomized controlled intervention were participated 135 subjects with AD including 45 of the control group. It lasted 6 months with pre-post tests (T0-T1) executed before and after six months of treatment. By having in focus the evaluation of GPR therapy effects on cognitive, proprioceptive, depressive, autonomy, gait and life quality of the above mentioned subjects.
Detailed Description
In order to assess the cognitive abilities of the patients a cognitive test was administered which acts through a scale concerning depression and mood evaluation as well as a questionnaire was developed aiming to evaluate the examined subjects' functional abilities: Mini Mental State Examination (MMSE), Quality of Life in Alzheimer Disease (QoL-AD), geriatric Depression Scale (GDS), Barthel Index (BI), Neuropsychiatric Inventory (NPI), Tinetti Scale (TS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Type Dementia, Cognitive Decline, Postural; Strain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GPR Intervention Research group
Arm Type
Experimental
Arm Description
A total of 135 subjects with AD in the mild or moderate phase participated in the study from which 90 pertain to research group.The intervention implemented to the patients with AD was the Global Postural therapy which lasted about 30-40 min in repeated sessions of 2 meetings per week by making 48 sessions in total during a six month period.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
45 subjects of the study belongs to the control group which has not received the same treatment .
Intervention Type
Other
Intervention Name(s)
GPR Intervention Research group
Intervention Description
The research intervention consisted in the reappointment of three GPR therapeutic postures.
Primary Outcome Measure Information:
Title
Cognitive Abilities Measurement
Description
The therapeutist provides the Mini Mental State Examination (MMSE) scale records. The evaluation consits in a 0-30 points-scale. Lower scores imply the severity of dementia.
Time Frame
Change from baseline cognitive evaluation at 6'th month
Secondary Outcome Measure Information:
Title
Quality of Life in Alzheimer's disease (QoL-AD) Questionnaire
Description
The therapeutist measures in the begining and in the end of the study the quality of life in patients with Alzheimer's disease (QoL-AD). This questionnaire consists in 13 elements referring to the perception that patients have concerning various aspects of their life: mood, health, cognition, environment and functional capacity. The range of scores is 13-52, were higher scores indicate a better life quality.
Time Frame
Change from baseline cognitive evaluation at 6'th month
Title
Geriatric Depression Scale (GDS) Questionnaire
Description
The version of 15 articles was used, which given its length can be validly and reliably resolved by patients themselves in the quality of a self-report questionnaire aiming to investigate the possible presence of depressive symptoms.
Time Frame
Change from baseline cognitive evaluation at 6'th month
Title
Barthel Index (BI)
Description
This scale is used by therapist to measure the performance in the basic activities of daily life of AD patients. The maximum score used is 100 points and refers to the patient's independence in all basic daily living activities.
Time Frame
Change from baseline cognitive evaluation at 6'th month
Title
Neuropsychiatric Inventory (NPI)
Description
This test includes 12 symptoms scored according to the phenomenon severity and frequency. It is a helpful instrument for the therapist because of specifically designed for the assessment of psycho-behavioral disorders in individuals with cognitive impairment.
Time Frame
Change from baseline cognitive evaluation at 6'th month
Title
Tinetti Scale (TS)
Description
The therapist used the equilibrium sub-scale, which consists in 7 elements and has a score between 0 and 13. Highest scores indicate a better balance.
Time Frame
Change from baseline cognitive evaluation at 6'th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Alzheimer's Disease
Older than 40 years of age
Male and female
Intellectual disability
Cognitive impairment
Able to do daily activities on his own
No presence of any other neurological and psychological disease
No presence of brain tumors
Exclusion Criteria:
No presence of Alzheimer's Disease
Under 40 years old
Presence of brain tumors
Neurological patients
Presence of psychiatric disease
Depression symptoms
Presence of neuromuscular disease
Ictus
Aggressive patients
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All participants signed the informed consent and their family members were also informed concerning the purpose of the study. Correspondingly the data were provided by the physiotherapists who performed the above mentioned technique. Thereafter the study was validated and approved by the Ethics Committee of Catholic University of Murcia.
Citations:
PubMed Identifier
34951386
Citation
Todri J, Lena O, Todri A, Fuentes JM. Does the Global Postural Re-Education Affect the Psychological and Postural Aspects of Alzheimer Disease Patients? A Six Months Quasi-Experimental Study. Curr Alzheimer Res. 2021;18(13):1057-1065. doi: 10.2174/1567205019666211223094811.
Results Reference
derived
Learn more about this trial
The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients
We'll reach out to this number within 24 hrs