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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04021888
• Other study ID #: KELES
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: July 2019
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 30, 2020
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aerobic Exercise
• Alzheimer Disease
• Breathing Exercise
• Resistance Training

Intervention

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

Locations

Country	Name	City	State
Turkey	Elvan Keles	Izmi?r

Sponsors (3)

Lead Sponsor	Collaborator
Dokuz Eylul University	Gorsev Yener, Sevgi Ozalevli

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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