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Completed

NCT Number: NCT04981587

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

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Key information

Conditions

Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Dementia Dementia; Alzheimer's Type (Etiology) Elderly Fall Risk Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Resistance Training Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.F.A La Estrella, Jaén, Andalusia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength exercise

Procedure

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

Usual treatment

Other

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

Primary outcomes

  1. 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

  1. Change from baseline Activities specific balance confidence scale (ABC scale) at 3 and 6 months

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

    This questionnaire allows to measure the balance of a person Score: 0-100% High percentage means better result

  2. Change from baseline Lawton Instrumental Activities of Daily Living Scale (IADL) at 3 and 6 months

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

    This tool gives us information about performance in activities of daily living Score: 0-8 High score means better result

  3. Change from baseline Quality of life Alzheimer Disease (QoL-AD) at 3 and 6 months

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

    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

  4. Change from baseline FRAIL test at 3 and 6 months

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

    This rapid test allows to determine the state of frailty of older people Score: 0-5 High score means worst result

  5. Change from baseline Mini Mental State Examination (MMSE) at 3 and 6 months

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

    This test gives us information about the cognitive performance of the participants Score: 0-30 High score means better result

  6. Change from baseline Neuropsychiatric Inventory (NPI-Q) at 3 and 6 months

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

    This tool allows to specify the neuropsychiatric symptoms patients present Score: 0-36 High score means worst result

  7. Change from baseline Manual dynamometry at 1,2,3 and 6 months

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

    This test allows to quantify force an individual presents in a simple way Score: 0-∞ High score means better result

  8. Modified Borg scale

    Time frame: 3 times/week during strength exercises sessions

    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

  9. Change from baseline One Maximum repetition strength test (1 MR) at 1,2,3 and 6 months

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

    Allows you easily to assess maximum strength Score: 0-∞ High score means more strength level

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 29, 2021
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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