Back to resultsEffects of Strength Exercise on Fall Risk in Elderly With Alzheimer's Disease
Primary Purpose
Alzheimer Disease, Dementia; Alzheimer's Type (Etiology), Fall Risk
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Strength exercise
Usual treatment
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring alzheimer disease, elderly, exercise, fall risk
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
Sites / Locations
- A.F.A La Estrella
- Alexander achalandabaso
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group
Control group
Arm Description
This is the group that receives strength exercise in addition to usual treatment
This is the group that only receives usual treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04981587
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
March 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Interventional study to show the effects of strength exercise on fall risk in elderly with Alzheimer's disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia; Alzheimer's Type (Etiology), Fall Risk, Elderly, Resistance Training
Keywords
alzheimer disease, elderly, exercise, fall risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This is the group that receives strength exercise in addition to usual treatment
Arm Title
Control group
Arm Type
Other
Arm Description
This is the group that only receives usual treatment
Intervention Type
Procedure
Intervention Name(s)
Strength exercise
Intervention Description
Strength exercise protocol for upper and lower limbs, using weights and elastic bands
Intervention Type
Other
Intervention Name(s)
Usual treatment
Intervention Description
The usual treatment is based on activities to enhance brain functions: attention, memory, executive functions, language and orientation.
Primary Outcome Measure Information:
Title
Change from baseline Short physical performance battery (SPPB) at 3 and 6 months
Description
Informs about fall risk and mobility Score: 0-12 High score means better result
Time Frame
Baseline, 3 and 6 months (3 months after intervention)
Secondary Outcome Measure Information:
Title
Change from baseline Activities specific balance confidence scale (ABC scale) at 3 and 6 months
Description
This questionnaire allows to measure the balance of a person Score: 0-100% High percentage means better result
Time Frame
Baseline, 3 and 6 months (3 months after intervention)
Title
Change from baseline Lawton Instrumental Activities of Daily Living Scale (IADL) at 3 and 6 months
Description
This tool gives us information about performance in activities of daily living Score: 0-8 High score means better result
Time Frame
Baseline, 3 and 6 months (3 months after intervention)
Title
Change from baseline Quality of life Alzheimer Disease (QoL-AD) at 3 and 6 months
Description
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
Time Frame
Baseline, 3 and 6 months (3 months after intervention)
Title
Change from baseline FRAIL test at 3 and 6 months
Description
This rapid test allows to determine the state of frailty of older people Score: 0-5 High score means worst result
Time Frame
Baseline, 3 and 6 months (3 months after intervention)
Title
Change from baseline Mini Mental State Examination (MMSE) at 3 and 6 months
Description
This test gives us information about the cognitive performance of the participants Score: 0-30 High score means better result
Time Frame
Baseline, 3 and 6 months (3 months after intervention)
Title
Change from baseline Neuropsychiatric Inventory (NPI-Q) at 3 and 6 months
Description
This tool allows to specify the neuropsychiatric symptoms patients present Score: 0-36 High score means worst result
Time Frame
Baseline, 3 and 6 months (3 months after intervention)
Title
Change from baseline Manual dynamometry at 1,2,3 and 6 months
Description
This test allows to quantify force an individual presents in a simple way Score: 0-∞ High score means better result
Time Frame
Baseline, 1, 2, 3 and 6 months (3 months after intervention)
Title
Modified Borg scale
Description
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
Time Frame
3 times/week during strength exercises sessions
Title
Change from baseline One Maximum repetition strength test (1 MR) at 1,2,3 and 6 months
Description
Allows you easily to assess maximum strength Score: 0-∞ High score means more strength level
Time Frame
Baseline, 1 , 2 , 3 and 6 months (3 months after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso, Phd
Organizational Affiliation
University of Jaen
Official's Role
Study Director
Facility Information:
Facility Name
A.F.A La Estrella
City
Jaén
State/Province
Andalucía
Country
Spain
Facility Name
Alexander achalandabaso
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
12. IPD Sharing Statement
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Effects of Strength Exercise on Fall Risk in Elderly With Alzheimer's Disease
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