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Clinical Trials/NCT04021888
NCT04021888UnknownNot Applicable

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

Dokuz Eylul University1 site in 1 country60 target enrollmentStarted: July 16, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Change in cognition

Study Overview

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

Detailed Description

Exercise group was trained 3 times a week under the supervision of a physiotherapist and encouraged to exercise at home on other days

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

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)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •aged over 65 years
  • •can walk independent

Exclusion Criteria

  • •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

Arms & Interventions

Exercise Group

Experimental

Intervention: Exercise (Other)

Control

Active Comparator

Intervention: Exercise (Other)

Outcomes

Primary Outcomes

Change in cognition

Time Frame: Baseline, 12th week

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.

Secondary Outcomes

  • Change in physical performance(Baseline, 12th week)
  • Change in pulmonary functions(Baseline, 12th week)
  • Change in respiratory muscle strength(Baseline, 12th week)
  • Change in functional capacity(Baseline, 12th week)
  • Change in sleepiness(Baseline, 12th week)
  • Change in quality of life(Baseline, 12th week)
  • Change in activities of daily living(Baseline, 12th week)
  • Change in depression(Baseline, 12th week)
  • Change in muscle strength(Baseline, 12th week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elvan Keles

Research Assistant

Dokuz Eylul University

Study Sites (1)

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