Alzheimer's Type DementiaGPRNCT03732053
The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients
A study testing GPR Intervention Research group in people with Alzheimer's Type Dementia and Cognitive Decline, run by Universidad Católica San Antonio de Murcia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Alzheimer's Type Dementia, Cognitive Decline, Postural; Strain
- What is being tested?
- GPR Intervention Research group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2016to 3 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No presence of Alzheimer's Disease
- Under 40 years old
- Presence of brain tumors
- Neurological patients
- Presence of psychiatric disease
- Depression symptoms
Show all 9Show fewer
- Presence of neuromuscular disease
- Ictus
- Aggressive patients
About this study
Official title: 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.
Read the 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).
- Being tested
- GPR Intervention Research group
- Medical subject headings
- Cognitive Dysfunction, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPR Intervention Research groupOther
The research intervention consisted in the reappointment of three GPR therapeutic postures.
| Study group | Role | What they receive |
|---|---|---|
| GPR Intervention Research group | Experimental | 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. Receives: Other: GPR Intervention Research group |
| Control Group | No intervention | 45 subjects of the study belongs to the control group which has not received the same treatment . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline cognitive evaluation at 6'th month
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline cognitive evaluation at 6'th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start5 Dec 2016
- Primary completion10 Mar 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Type DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasemin Todri, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732053
- Sponsor's protocol ID
- BJ8674287
- Acronym
- GPR
- Status last verified
- Nov 2019
- First submitted
- 17 Apr 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 34951386
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Physical Rehabilitation in the Enhancement of Proprioceptive and Cognitive Aspects on Alzheimer Disease Patients
- ClinicalTrials.gov ID
- NCT03732053
- Acronym / sponsor ID
- GPR / BJ8674287
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| GPR Intervention Research group | Experimental | Other: GPR Intervention Research groupA 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. |
| Control Group | No intervention | –45 subjects of the study belongs to the control group which has not received the same treatment . |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of Alzheimer's Disease
- Older than 40 years of age
- Male and female
- Intellectual disability
- Cognitive impairment
Key exclusion criteria (9 listed)
- No presence of Alzheimer's Disease
- Under 40 years old
- Presence of brain tumors
- Neurological patients
- Presence of psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPR Intervention Research groupThe research intervention consisted in the reappointment of three GPR therapeutic postures. | Other | GPR Intervention Research group |
Primary outcome
Cognitive Abilities Measurement
Time frame: Change from baseline cognitive evaluation at 6'th month
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.
5 secondary outcomes
Quality of Life in Alzheimer's disease (QoL-AD) Questionnaire
Time frame: Change from baseline cognitive evaluation at 6'th month
Geriatric Depression Scale (GDS) Questionnaire
Time frame: Change from baseline cognitive evaluation at 6'th month
Barthel Index (BI)
Time frame: Change from baseline cognitive evaluation at 6'th month
Neuropsychiatric Inventory (NPI)
Time frame: Change from baseline cognitive evaluation at 6'th month
Tinetti Scale (TS)
Time frame: Change from baseline cognitive evaluation at 6'th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Derived from this study: PubMed 34951386Todri 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Alzheimer's Type Dementia
RecruitingPhase 2
A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Dementia, Alzheimer's Type, Alzheimer's Disease
Active, not recruitingPhase 2
Dexmedetomidine Transdermal Systems (DMTS) Treatment for Agitation Associated With Dementia of the Alzheimer's Type
Agitation
Active, not recruitingPhase 2/3
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Dementia Moderate, Dementia, Mild
RecruitingObservational study
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis
Neurodegenerative Diseases, Dementia
RecruitingObservational study
Dominantly Inherited Alzheimer Network (DIAN)
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GPR Intervention Research group in people with Alzheimer's Type Dementia and Cognitive Decline, run by Universidad Católica San Antonio de Murcia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Abilities Measurement (time frame: Change from baseline cognitive evaluation at 6'th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.