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Clinical Trials/NCT04981587
NCT04981587CompletedNot Applicable

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

University of Jaén2 sites in 1 country64 target enrollmentStarted: May 1, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
64
Locations
2
Primary Endpoint
Change from baseline Short physical performance battery (SPPB) at 3 and 6 months
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention group

Experimental

This is the group that receives strength exercise in addition to usual treatment

Intervention: Strength exercise (Procedure)

Intervention group

Experimental

This is the group that receives strength exercise in addition to usual treatment

Intervention: Usual treatment (Other)

Control group

Other

This is the group that only receives usual treatment

Intervention: Usual treatment (Other)

Outcomes

Primary Outcomes

Change from baseline Short physical performance battery (SPPB) at 3 and 6 months

Time Frame: Baseline, 3 and 6 months (3 months after intervention)

Informs about fall risk and mobility Score: 0-12 High score means better result

Secondary Outcomes

  • Change from baseline FRAIL test at 3 and 6 months(Baseline, 3 and 6 months (3 months after intervention))
  • 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))
  • 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))
  • Change from baseline Quality of life Alzheimer Disease (QoL-AD) at 3 and 6 months(Baseline, 3 and 6 months (3 months after intervention))
  • Change from baseline Neuropsychiatric Inventory (NPI-Q) at 3 and 6 months(Baseline, 3 and 6 months (3 months after intervention))
  • Change from baseline Mini Mental State Examination (MMSE) at 3 and 6 months(Baseline, 3 and 6 months (3 months after intervention))
  • Change from baseline Activities specific balance confidence scale (ABC scale) at 3 and 6 months(Baseline, 3 and 6 months (3 months after intervention))
  • Change from baseline Manual dynamometry at 1,2,3 and 6 months(Baseline, 1, 2, 3 and 6 months (3 months after intervention))
  • Modified Borg scale(3 times/week during strength exercises sessions)

Investigators

Sponsor
University of Jaén
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexander Achalandabaso

Principal investigator

University of Jaén

Study Sites (2)

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