The Effects of Exercise Program in Alzheimer's Patients With Mild to Moderate Stage Alzheimer's Disease

NCT04021888 | Unknown DMC

• 1 other identifier: KELES
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this trial is to investigate the feasibility of an exercise program consisting of respiratory exercises, aerobic exercises and strengthening exercises in mild to moderate Alzheimer's disease. The trial also aims to investigate the effectiveness of the exercise program on respiratory symptoms, exercise capacity, cognition, physical performance, depression, sleepiness, activities of daily living and quality of life. Patients will be divided into exercise (intervention) and control group by randomization method. The study is planned to be performed with a total of 60 patients, 30 in each group. The patients in the exercise group will be given breathing exercises aerobic exercises and strengthening exercises for 2 days a week for 12 weeks, about 30-40 minutes while the patients in the control group will be provided with suggestions, home exercise program and daily life activities

Conditions

Alzheimer Disease; Aerobic Exercise; Breathing Exercise; Resistance Training

Outcome Measures

Primary Outcomes (1)

• Change in cognition

  The Mini-Mental State Examination (MMSE) is used to measure cognitive impairment in older adults. It assesses different subset of cognitive status including attention, language, memory, orientation, visuospatial proficiency.

  Baseline, 12th week

Secondary Outcomes (9)

• Change in pulmonary functions

  Baseline, 12th week

• Change in respiratory muscle strength

  Baseline, 12th week

• Change in functional capacity

  Baseline, 12th week

• Change in physical performance

  Baseline, 12th week

• Change in sleepiness

  Baseline, 12th week

Study Arms (2)

Exercise Group

EXPERIMENTAL

Other: Exercise

Control

ACTIVE COMPARATOR

Other: Exercise

Interventions

Exercise OTHER

Education of patients and their caregivers, deep breathing exercise, aerobic exercise and resistance training with elastic bands

Control; Exercise Group

Eligibility Criteria

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

You may qualify if:

• aged over 65 years
• can walk independent

You may not qualify if:

• can't see
• have done any exercise in the last 6 months
• have a major and uncontrolled orthopedic, neurological or cardiopulmonary problem that restricts functioning
• having non Alzheimer's disease dementia

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Sevgi Ozalevli: collaborator
• Gorsev Yener: collaborator

Study Sites (1)

Elvan Keleş

İzmi̇r, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Elvan Keleş, PT, PhD

  İzmir Katip Çelebi Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An assessor who was blinded to treatment groups assessed clinical outcomes before the treatment process. The same assessor was also repeated assessments at 13th week (at the end of treatment process)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 16, 2019
• Study Start: July 16, 2018
• Primary Completion: October 8, 2018
• Study Completion: July 30, 2020
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

TU (1)