CClinicalTrials.gg
CompletedNCT03981159ExCiTE-AUpdated Jun 10, 2019

Effect of Exercise Training in Alzheimer's Patients

An interventional study of Physical training in Alzheimer Disease, sponsored by University of Genova. Completed at 1 site in Italy. Open to participants aged 80 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by University of Genova · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Mar 2017, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
80 Years to 90 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Genova is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
80 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Active group (under physical training)

    Subjects belonging to this arm underwent physical training for three months, twice per week (60 minutes per session).

    Other: Physical training

  • No intervention
    Passive group (no physical training)

    Subjects served as controls.

Interventions

  • OtherPhysical training

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

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What researchers measure

Primary outcomes

  1. Tinetti test

    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.

    Time frame: Approximately 10-15 minutes

  2. Berg Balance Scale

    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.

    Time frame: Approximately 20 minutes

  3. 6-minute walking test

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

    Time frame: 6 minutes

  4. Timed up and go test

    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.

    Time frame: Approximately 14 seconds

  5. "Walking While Talking" test

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

    Time frame: Approximately 1 minute

  6. Red blood cell count

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  7. White blood cell count

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  8. Hemoglobin

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  9. Platelet count

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  10. Hematocrit

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  11. Triglycerides

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  12. Cholesterol

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  13. Total bilirubin

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  14. AST (aspartate aminotransferase)

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  15. ALT (alanine aminotransferase)

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  16. Blood pressure

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  17. Creatinine

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  18. Urea

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  19. Glucose

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  20. Sodium

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  21. Calcium

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

  22. Potassium

    Assessed with routine blood/biochemical assays

    Time frame: Approximately 10-15 minutes

07

Study locations

1 site
  • University of Genova
    Genoa, 16132, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03981159
Lead sponsor
University of Genova
Responsible party
Maamer Slimani (Principal Investigator, University of Genova) — Principal investigator
First posted
Jun 10, 2019
Start date
Mar 1, 2017
Primary completion
Jul 1, 2017
Completion
Nov 15, 2017
Last update
Jun 10, 2019

Study contacts

Nicola L Bragazzi, MD, PhD, MPH
principal investigator · Universita degli Studi di Genova

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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