Skip to main content
OpenTrials
Completed

NCT Number: NCT03981159

Effect of Exercise Training in Alzheimer's Patients

The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

80 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Genova

Genoa, 16132, Italy

About this study

Alzheimer's disease is a neurodegenerative disease characterized by progressive and irreversible degeneration of nerve cells. The loss of these cells leads to the continuous decline in muscle function with alterations in biochemical and haematological parameters. The objective of this study was to examine the effects of exercise training on physical function and biochemical markers in elderly Alzheimer's disease patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with official diagnosis of Alzheimer's disease;
  • Subjects with MMSE higher than12.

Exclusion criteria

  • Subjects with MMSE below 12 (indicating severe dementia and impairment).

Treatment and study plan

Physical training

Other

Physical training for three months, twice per week (60 minutes per session).

Primary outcomes

  1. Tinetti test

    Time frame: Approximately 10-15 minutes

    The 3-likert test assesses balance and gait abilities with an individual sitting in an armless chair, rising up, staying standing, turning 360° and then sitting back down. Gait is scored over 12 and balance is scored over 16, totalling 28 points.

  2. Berg Balance Scale

    Time frame: Approximately 20 minutes

    The 14-item 5-likert (from 0 to 4) scale objectively determines a patient's balance ability during a series of predetermined tasks. Scores of each item are summed up: the total score ranges from 0 to 56. The lowest the score the lowest is the level of function, the highest the score the highest is the level of function.

  3. 6-minute walking test

    Time frame: 6 minutes

    This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.

  4. Timed up and go test

    Time frame: Approximately 14 seconds

    The test measures abilities of a patient initially in a seated position The patient is then asked to stand up up, walk 3 meters, turn around, walk back to the chair and sit down.

  5. "Walking While Talking" test

    Time frame: Approximately 1 minute

    This test is a dual-task test, consisting in walking while reciting the alphabet or alternate letters of the alphabet.

  6. Red blood cell count

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  7. White blood cell count

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  8. Hemoglobin

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  9. Platelet count

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  10. Hematocrit

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  11. Triglycerides

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  12. Cholesterol

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  13. Total bilirubin

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  14. AST (aspartate aminotransferase)

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  15. ALT (alanine aminotransferase)

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  16. Blood pressure

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  17. Creatinine

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  18. Urea

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  19. Glucose

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  20. Sodium

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  21. Calcium

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

  22. Potassium

    Time frame: Approximately 10-15 minutes

    Assessed with routine blood/biochemical assays

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Registry information

Official study title

Effect of Exercise Training on Biochemical and Gait/Balance Parameters in Alzheimer's Patients

Acronym: ExCiTE-A

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2019
Registry last updated
Jun 10, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.