Effect of Exercise Training in Alzheimer's Patients

NCT03981159 | Completed DMC

• 1 other identifier: ExCiTE-A-17-0020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (22)

• 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

Study Arms (2)

Active group (under physical training)

EXPERIMENTAL

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

Other: Physical training

Passive group (no physical training)

NO INTERVENTION

Subjects served as controls.

Interventions

Physical training OTHER

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

Active group (under physical training)

Eligibility Criteria

• Age: 80 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

University of Genova

Genoa, 16132, Italy

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nicola L Bragazzi, MD, PhD, MPH

  Universita degli Studi di Genova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-pharmacological interventional study

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: June 10, 2019
• Study Start: March 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: November 15, 2017
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)