Effect of Exercise Training in Alzheimer's Patients

Alzheimer Disease Clinical Trial

— ExCiTE-A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981159
• Other study ID #: ExCiTE-A-17-0020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: June 2019
• Source: University of Genova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 15, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
Italy	University of Genova	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 10-15 minutes
Primary	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.	Approximately 20 minutes
Primary	6-minute walking test	This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.	6 minutes
Primary	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.	Approximately 14 seconds
Primary	"Walking While Talking" test	This test is a dual-task test, consisting in walking while reciting the alphabet or alternate letters of the alphabet.	Approximately 1 minute
Primary	Red blood cell count	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	White blood cell count	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Hemoglobin	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Platelet count	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Hematocrit	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Triglycerides	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Cholesterol	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Total bilirubin	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	AST (aspartate aminotransferase)	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	ALT (alanine aminotransferase)	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Blood pressure	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Creatinine	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Urea	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Glucose	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Sodium	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Calcium	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Primary	Potassium	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes