Effects of Strength Exercise on Fall Risk in Elderly With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Interventional study to show the effects of strength exercise on fall risk in elderly with Alzheimer's disease

Official Title
-----------------
Effects of Strength Exercise on Fall Risk in Elderly With Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease, Dementia; Alzheimer's Type (Etiology), Fall Risk, Elderly, Resistance Training

Intervention / Treatment
-----------------
* Procedure: Strength exercise
* Other: Usual treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: accept to participate in the study, through informed consent subjects aged 60 or over with medical diagnosis of Azlheimer´s disease minimal physical and mental state to perform the cognitive tests and strength exercise routine Exclusion Criteria: Neurodegenerative disease other than Alzheimer's disease Suffering from serious somatic or psychiatric illnesses Patients who have practiced strength exercise regularly

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This is the group that receives strength exercise in addition to usual treatment | Procedure: Strength exercise<br>* Strength exercise protocol for upper and lower limbs, using weights and elastic bands<br>Other: Usual treatment<br>* The usual treatment is based on activities to enhance brain functions: attention, memory, executive functions, language and orientation.<br>|
| Other: Control group<br>This is the group that only receives usual treatment | Other: Usual treatment<br>* The usual treatment is based on activities to enhance brain functions: attention, memory, executive functions, language and orientation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Short physical performance battery (SPPB) at 3 and 6 months | Informs about fall risk and mobility Score: 0-12 High score means better result | Baseline, 3 and 6 months (3 months after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Activities specific balance confidence scale (ABC scale) at 3 and 6 months | This questionnaire allows to measure the balance of a person Score: 0-100% High percentage means better result | Baseline, 3 and 6 months (3 months after intervention) | 
| Change from baseline Lawton Instrumental Activities of Daily Living Scale (IADL) at 3 and 6 months | This tool gives us information about performance in activities of daily living Score: 0-8 High score means better result | Baseline, 3 and 6 months (3 months after intervention) | 
| Change from baseline Quality of life Alzheimer Disease (QoL-AD) at 3 and 6 months | Through this test we can know the level of quality of life of users who suffer from this disease Score: 0-52 High score means better result | Baseline, 3 and 6 months (3 months after intervention) | 
| Change from baseline FRAIL test at 3 and 6 months | This rapid test allows to determine the state of frailty of older people Score: 0-5 High score means worst result | Baseline, 3 and 6 months (3 months after intervention) | 
| Change from baseline Mini Mental State Examination (MMSE) at 3 and 6 months | This test gives us information about the cognitive performance of the participants Score: 0-30 High score means better result | Baseline, 3 and 6 months (3 months after intervention) | 
| Change from baseline Neuropsychiatric Inventory (NPI-Q) at 3 and 6 months | This tool allows to specify the neuropsychiatric symptoms patients present Score: 0-36 High score means worst result | Baseline, 3 and 6 months (3 months after intervention) | 
| Change from baseline Manual dynamometry at 1,2,3 and 6 months | This test allows to quantify force an individual presents in a simple way Score: 0-∞ High score means better result | Baseline, 1, 2, 3 and 6 months (3 months after intervention) | 
| Modified Borg scale | In this way we can measure the level of perceived exertion during the intervention with strength exercise Score: 0-10 High score means more fatigue | 3 times/week during strength exercises sessions | 
| Change from baseline One Maximum repetition strength test (1 MR) at 1,2,3 and 6 months | Allows you easily to assess maximum strength Score: 0-∞ High score means more strength level | Baseline, 1 , 2 , 3 and 6 months (3 months after intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, alzheimer disease, exercise, fall risk