AzTrials
AzTrials

Alzheimer DiseaseNCT04981587

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

A study testing Strength exercise and Usual treatment in people with Alzheimer Disease and Dementia; Alzheimer's Type (Etiology), run by University of Jaén at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Strength exercise and Usual treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesSpain
Study dates
1 May 2021to 4 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Alexander achalandabaso

    Alcalá de Henares, Madrid, 28805

  • A.F.A La Estrella

    Jaén, Andalusia

Other trials in Spain

About this study

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

Being tested
Strength exercise, Usual treatment
Keywords
alzheimer disease, elderly, exercise, fall risk
Medical subject headings
Alzheimer Disease, Dementia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength exerciseProcedure or surgery

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

  • Usual treatmentOther

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

Study groups in NCT04981587
Study groupRoleWhat they receive
Intervention groupExperimentalThis is the group that receives strength exercise in addition to usual treatment
Receives: Procedure: Strength exercise; Other: Usual treatment
Control groupOtherThis is the group that only receives usual treatment
Receives: Other: Usual treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 3 and 6 months (3 months after intervention)

Secondary outcomes (9)

  1. 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

    Measured: Baseline, 3 and 6 months (3 months after intervention)

  2. 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

    Measured: Baseline, 3 and 6 months (3 months after intervention)

  3. 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

    Measured: Baseline, 3 and 6 months (3 months after intervention)

  4. 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

    Measured: Baseline, 3 and 6 months (3 months after intervention)

  5. 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

    Measured: Baseline, 3 and 6 months (3 months after intervention)

  6. 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

    Measured: Baseline, 3 and 6 months (3 months after intervention)

  7. 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

    Measured: Baseline, 1, 2, 3 and 6 months (3 months after intervention)

  8. 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

    Measured: 3 times/week during strength exercises sessions

  9. 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

    Measured: Baseline, 1 , 2 , 3 and 6 months (3 months after intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start1 May 2021
  3. Primary completion10 Dec 2021
  4. Study completion4 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04981587
Sponsor's protocol ID
CEIH/FEB.21/8.TES
Status last verified
Mar 2022
First submitted
19 Jul 2021
Last updated
7 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Camara-Calmaestra R, Martinez-Amat A, Aibar-Almazan A, Hita-Contreras F, de Miguel-Hernando N, Rodriguez-Almagro D, Jimenez-Garcia JD, Achalandabaso-Ochoa A. Resistance exercise to reduce risk of falls in people with Alzheimer's disease: a randomised clinical trial. Physiotherapy. 2025 Mar;126:101440. doi: 10.1016/j.physio.2024.101440. Epub 2024 Oct 28.

    PubMed 39689408

Questions about this trial

What is this clinical trial studying?

A study testing Strength exercise and Usual treatment in people with Alzheimer Disease and Dementia; Alzheimer's Type (Etiology), run by University of Jaén at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Short physical performance battery (SPPB) at 3 and 6 months (time frame: Baseline, 3 and 6 months (3 months after intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04981587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in