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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Elderly; Resistance Training; Fall Risk; Dementia; Alzheimer's Type (Etiology)
• Intervention / Treatment: Procedure: Strength exercise; Other: Usual treatment

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Jaén, Andalucía, Spain
      • A.F.A La Estrella
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Alexander achalandabaso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; This is the group that receives strength exercise in addition to usual treatment	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.
Other: Control group; This is the group that only receives usual treatment	Other: Usual treatment; The usual treatment is based on activities to enhance brain functions: attention, memory, executive functions, language and orientation.

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)

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: exercise; elderly; fall risk; alzheimer disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: CEIH/FEB.21/8.TES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No