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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04981587
Other study ID # CEIH/FEB.21/8.TES
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date March 4, 2022

Study information

Verified date March 2022
Source University of Jaén
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Interventional study to show the effects of strength exercise on fall risk in elderly with Alzheimer's disease


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date March 4, 2022
Est. primary completion date December 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - accept to participate in the study, through informed consent - subjects aged 60 or over with medical diagnosis of AzlheimerĀ“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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Strength exercise
Strength exercise protocol for upper and lower limbs, using weights and elastic bands
Other:
Usual treatment
The usual treatment is based on activities to enhance brain functions: attention, memory, executive functions, language and orientation.

Locations

Country Name City State
Spain Alexander achalandabaso Alcalá De Henares Madrid
Spain A.F.A La Estrella Jaén Andalucía

Sponsors (1)

Lead Sponsor Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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: 0-8 High score means better result Baseline, 1, 2, 3 and 6 months (3 months after intervention)
Secondary 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
Secondary 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: 0-8 High score means more strength level Baseline, 1 , 2 , 3 and 6 months (3 months after intervention)
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