Effect of Exercise Training in Alzheimer's Patients (ExCiTE-A)

Effect of Exercise Training on Biochemical and Gait/Balance Parameters 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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: Physical training

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genoa, Italy, 16132
    • University of Genova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years to 90 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Physical training for three months, twice per week (60 minutes per session).
NO_INTERVENTION: Passive group (no physical training); Subjects served as controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
6-minute walking test	This test is a sub-maximal exercise used to evaluate aerobic capacity and endurance.	6 minutes
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
"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
Red blood cell count	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
White blood cell count	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Hemoglobin	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Platelet count	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Hematocrit	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Triglycerides	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Cholesterol	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Total bilirubin	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
AST (aspartate aminotransferase)	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
ALT (alanine aminotransferase)	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Blood pressure	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Creatinine	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Urea	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Glucose	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Sodium	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Calcium	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes
Potassium	Assessed with routine blood/biochemical assays	Approximately 10-15 minutes

Collaborators and Investigators

• Sponsor: University of Genova
• Investigators: Principal Investigator: Nicola L Bragazzi, MD, PhD, MPH, Università degli Studi di Genova

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): November 15, 2017

Study Registration Dates

• First Submitted: March 3, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (ACTUAL): June 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ExCiTE-A-17-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No