The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients (GPR)

The Effectiveness of Physical Rehabilitation in the Enhancement of Proprioceptive and Cognitive Aspects on Alzheimer Disease Patients

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Decline; Alzheimer's Type Dementia; Postural; Strain
• Intervention / Treatment: Other: GPR Intervention Research group

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).

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GPR Intervention Research group; 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.	Other: GPR Intervention Research group; The research intervention consisted in the reappointment of three GPR therapeutic postures.
No Intervention: Control Group; 45 subjects of the study belongs to the control group which has not received the same treatment .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline cognitive evaluation at 6'th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline cognitive evaluation at 6'th month
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.	Change from baseline cognitive evaluation at 6'th month
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.	Change from baseline cognitive evaluation at 6'th month
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.	Change from baseline cognitive evaluation at 6'th month
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.	Change from baseline cognitive evaluation at 6'th month

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): March 10, 2017
• Study Completion (Actual): July 3, 2017

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: November 3, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: BJ8674287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No