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

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

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease; Resistance Training; Aerobic Exercise; Breathing Exercise
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmi̇r, Turkey, 35620
    • Elvan Keleş

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: Exercise; Education of patients and their caregivers, deep breathing exercise, aerobic exercise and resistance training with elastic bands
Experimental: Exercise Group	Other: Exercise; Education of patients and their caregivers, deep breathing exercise, aerobic exercise and resistance training with elastic bands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pulmonary functions	Pulmonary function test (PFT) is a generic term used to indicate a battery of studies or maneuvers that may be performed using standardized equipment to measure lung function.	Baseline, 12th week
Change in respiratory muscle strength	Measurement of respiratory muscle strength is useful in order to detect respiratory muscle weakness and to quantify its severity. Respiratory muscle strength is assessed by mouth pressures sustained for 1 s during maximal static manoeuvre against a closed shutter	Baseline, 12th week
Change in functional capacity	Six-minute walk test (6MWT) is a valid, reliable and useful test for assessing functional capacity of COPD patients. This test assesses distance walked over 6 minutes as a sub maximal test of aerobic capacity/endurance.	Baseline, 12th week
Change in physical performance	The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people.	Baseline, 12th week
Change in sleepiness	The Epworth sleepiness scale (ESS) is a questionnaire that's routinely used to assess daytime sleepiness. The person filling in the questionnaire rates how likely they are to doze off during the day in different situations. Patients scored eight questions according to the probability of sleeping 0, 1, 2, 3, and the sum of the eight questions was calculated. A high score indicates sleepiness. If the total score is greater than 10, it indicates the presence of pathological sleepiness.	Baseline, 12th week
Change in quality of life	The Alzheimer's Disease-Related Quality of Life (ADRQL), is consist of 13-item self-report and 13- item caregiver-report measures. Each item is evaluated on a 4-point scale (1 point is bad and 4 points is excellent)	Baseline, 12th week
Change in activities of daily living	Barthel Index for Activities of Daily Living (ADL) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). Points are given according to doing daily life activities dependently or independently. It ranges from 0 to 100 and 0 points refers to complete dependence, 100 points refers to independence The Lawton Instrumental Activities of Daily Living (IADL) Scale assesses a person's ability to perform tasks such as using a telephone, doing laundry, and handling finance. This scale consist of 8 question. Higher values represent a better outcome.	Baseline, 12th week
Change in depression	The Geriatric Depression Scale-Short Form (GDS-SF) is an instrument that was developed to assess depressive symptoms and screen for depression among older people. It can be selfadministered or presented as an interview, and the questions have a yes/no format in order to be easy to understand for older people who may suffer from impaired cognitive function. This scale has 15 questions. In the assessment of the scale, no to positive questions and yes to negative questions were matched with 1 point and total score of 6 and above was considered significant for depressive symptoms.	Baseline, 12th week
Change in muscle strength	The Jamar Handgrip Dynamometer is an instrument for measuring the maximum isometric strength of the hand and forearm muscles. The Takei Back and Leg Dynamometer measures peak pull force of the large muscle groups, these include: Legs,trunk,shoulders, arms.	Baseline, 12th week

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Collaborators: Sevgi Ozalevli; Gorsev Yener
• Investigators: Principal Investigator: Elvan Keleş, PT, PhD, İzmir Katip Çelebi Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): October 8, 2018
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: July 13, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 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: KELES

Drug and device information, study documents

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