Effect of Exercise Training in Alzheimer's Patients (ExCiTE-A)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Physical training
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease
Eligibility Criteria
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).
Sites / Locations
- University of Genova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Active group (under physical training)
Passive group (no physical training)
Arm Description
Subjects belonging to this arm underwent physical training for three months, twice per week (60 minutes per session).
Subjects served as controls.
Outcomes
Primary Outcome Measures
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.
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.
6-minute walking test
This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.
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.
"Walking While Talking" test
This test is a dual-task test, consisting in walking while reciting the alphabet or alternate letters of the alphabet.
Red blood cell count
Assessed with routine blood/biochemical assays
White blood cell count
Assessed with routine blood/biochemical assays
Hemoglobin
Assessed with routine blood/biochemical assays
Platelet count
Assessed with routine blood/biochemical assays
Hematocrit
Assessed with routine blood/biochemical assays
Triglycerides
Assessed with routine blood/biochemical assays
Cholesterol
Assessed with routine blood/biochemical assays
Total bilirubin
Assessed with routine blood/biochemical assays
AST (aspartate aminotransferase)
Assessed with routine blood/biochemical assays
ALT (alanine aminotransferase)
Assessed with routine blood/biochemical assays
Blood pressure
Assessed with routine blood/biochemical assays
Creatinine
Assessed with routine blood/biochemical assays
Urea
Assessed with routine blood/biochemical assays
Glucose
Assessed with routine blood/biochemical assays
Sodium
Assessed with routine blood/biochemical assays
Calcium
Assessed with routine blood/biochemical assays
Potassium
Assessed with routine blood/biochemical assays
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03981159
Brief Title
Effect of Exercise Training in Alzheimer's Patients
Acronym
ExCiTE-A
Official Title
Effect of Exercise Training on Biochemical and Gait/Balance Parameters in Alzheimer's Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Genova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-pharmacological interventional study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active group (under physical training)
Arm Type
Experimental
Arm Description
Subjects belonging to this arm underwent physical training for three months, twice per week (60 minutes per session).
Arm Title
Passive group (no physical training)
Arm Type
No Intervention
Arm Description
Subjects served as controls.
Intervention Type
Other
Intervention Name(s)
Physical training
Intervention Description
Physical training for three months, twice per week (60 minutes per session).
Primary Outcome Measure Information:
Title
Tinetti test
Description
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
Title
Berg Balance Scale
Description
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
Title
6-minute walking test
Description
This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.
Time Frame
6 minutes
Title
Timed up and go test
Description
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
Title
"Walking While Talking" test
Description
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
Title
Red blood cell count
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
White blood cell count
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Hemoglobin
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Platelet count
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Hematocrit
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Triglycerides
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Cholesterol
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Total bilirubin
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
AST (aspartate aminotransferase)
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
ALT (alanine aminotransferase)
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Blood pressure
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Creatinine
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Urea
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Glucose
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Sodium
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Calcium
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
Title
Potassium
Description
Assessed with routine blood/biochemical assays
Time Frame
Approximately 10-15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola L Bragazzi, MD, PhD, MPH
Organizational Affiliation
Universita degli Studi di Genova
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Genova
City
Genoa
ZIP/Postal Code
16132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Exercise Training in Alzheimer's Patients
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