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

Not Applicable

Completed

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

• Registration Number: NCT04981587
• Lead Sponsor: University of Jaén

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-07-29
• Primary Completion: 2021-12-10
• Status Verified: 2022-03
• Study Completion: 2022-03-04
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline FRAIL test at 3 and 6 months	Baseline, 3 and 6 months (3 months after intervention)	This rapid test allows to determine the state of frailty of older people Score: 0-5 High score means worst result
Change from baseline One Maximum repetition strength test (1 MR) at 1,2,3 and 6 months	Baseline, 1 , 2 , 3 and 6 months (3 months after intervention)	Allows you easily to assess maximum strength Score: 0-∞ High score means more strength level
Change from baseline Lawton Instrumental Activities of Daily Living Scale (IADL) at 3 and 6 months	Baseline, 3 and 6 months (3 months after intervention)	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	Baseline, 3 and 6 months (3 months after intervention)	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 Neuropsychiatric Inventory (NPI-Q) at 3 and 6 months	Baseline, 3 and 6 months (3 months after intervention)	This tool allows to specify the neuropsychiatric symptoms patients present Score: 0-36 High score means worst result
Change from baseline Mini Mental State Examination (MMSE) at 3 and 6 months	Baseline, 3 and 6 months (3 months after intervention)	This test gives us information about the cognitive performance of the participants Score: 0-30 High score means better result
Change from baseline Activities specific balance confidence scale (ABC scale) at 3 and 6 months	Baseline, 3 and 6 months (3 months after intervention)	This questionnaire allows to measure the balance of a person Score: 0-100% High percentage means better result
Change from baseline Manual dynamometry at 1,2,3 and 6 months	Baseline, 1, 2, 3 and 6 months (3 months after intervention)	This test allows to quantify force an individual presents in a simple way Score: 0-∞ High score means better result
Modified Borg scale	3 times/week during strength exercises sessions	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

Trial Locations

Locations (2)

A.F.A La Estrella; 🇪🇸 Jaén, Andalucía, Spain

Alexander achalandabaso; 🇪🇸 Alcalá De Henares, Madrid, Spain