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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981587
• Other study ID #: CEIH/FEB.21/8.TES
• Status: Completed
• Phase: N/A
• 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
• 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 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

Related Conditions & MeSH terms

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

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)