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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04021888
Other study ID # KELES
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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