NCT04981587

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

March 7, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

July 19, 2021

Last Update Submit

March 4, 2022

Conditions

Alzheimer DiseaseDementia; Alzheimer's Type (Etiology)Fall RiskElderlyResistance Training

Keywords

alzheimer diseaseelderlyexercisefall risk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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 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 FRAIL test 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)

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Procedure: Strength exerciseOther: Usual treatment

Control group

OTHER

This is the group that only receives usual treatment

Other: Usual treatment

Interventions

Strength exercisePROCEDURE

Strength exercise protocol for upper and lower limbs, using weights and elastic bands

Intervention group
Usual treatmentOTHER

The usual treatment is based on activities to enhance brain functions: attention, memory, executive functions, language and orientation.

Control groupIntervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neurodegenerative disease other than Alzheimer's disease
  • Suffering from serious somatic or psychiatric illnesses
  • Patients who have practiced strength exercise regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

A.F.A La Estrella

Jaén, Andalusia, Spain

Location

Alexander achalandabaso

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Alexander Achalandabaso, Phd

    University of Jaen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 29, 2021

Study Start

May 1, 2021

Primary Completion

December 10, 2021

Study Completion

March 4, 2022

Last Updated

March 7, 2022

Record last verified: 2022-03

Locations

ES(2)