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Comparison of the Effectiveness of Different Home Exercise Programs

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ClinicalTrials.gov Identifier: NCT03878394
Recruitment Status : Unknown
Verified March 2019 by Istanbul Medipol University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Istanbul Medipol University Hospital

Brief Summary:
Aging is defined as a functional change in the organism which is not reversible with time progression. With this change in the organism, physical and cognitive functions are decreasing, and the potential of the individual to establish a balance between the systems decreased. For this reason, the aim of this is to investigate the effects of different home exercise programs on cognitive function, balance and daily living activities in healthy individuals.

Condition or disease Intervention/treatment Phase
Cognitive Function 1, Social Other: aerobic exercise and balance exercises Other: aerobic exercise and balance exercises with cognitive exercises Not Applicable

Detailed Description:
40 healthy individuals between the ages of 60-80 who agreed to participate in the study will be included in the study. Participants will be divided into 2 groups randomly. Both groups will be given balance exercises with aerobic exercise. The second group will be given second additional cognitive task besides doing usual exercises that the first group is performing. Exercises will be given in the form of a home exercise program and the treatment will last for 6 weeks. The continuity of the exercises will be controlled by telerehabilitation method. The participants will be evaluated before and after the treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of the Effectiveness of Different Home Exercise Programs in Healthy Individuals
Estimated Study Start Date : March 18, 2019
Estimated Primary Completion Date : January 27, 2020
Estimated Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.
Other: aerobic exercise and balance exercises
The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.Exercise will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.

Experimental: Group 2
The second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.
Other: aerobic exercise and balance exercises
The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.Exercise will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.

Other: aerobic exercise and balance exercises with cognitive exercises
The second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.




Primary Outcome Measures :
  1. Montreal Cognitive Assessment (MOCA) [ Time Frame: 6 weeks ]
    Montreal Cognitive Assessment (MOCA) was developed by Nasreddine et al. to distinguish healthy individuals from individuals with mild cognitive impairment. MOCA evaluates 8 different functions including attention and concentration, executive functions, memory, language, visual-spatial skills, calculation and orientation and abstract thinking. The highest score is 30. 21 points and above are considered normal.

  2. Stroop Test [ Time Frame: 6 weeks ]
    The Stroop Test measures the speed of information processing, the ability to suppress a customary behavior, focused attention, the ability to perform an unusual behavior, and the ability to change perceptual setup under varying demands and under a disturbing effect. The standardization studies of Stroop Test in our country were performed by Karakaş et al. The Turkish form was named Stroop Test TBAG Form. The Stroop Test TBAG Form consists of four white cards. Each card has 6 rows sorted randomly and 4 items per line. These cards contain the stimulants of the test.

  3. Benton Face Recognition Test [ Time Frame: 6 weeks ]
    The face recognition test was developed by Benton in 1969. It is standardized to determine the capacity to identify and distinguish unrecognized human faces. This test consists of 22 pages of A4 size and there are face pictures on these pages. Only one page of pages is numbered. There is a stimulant picture on pages with no page numbers. Numbered pages have 6 pictures to select from among the responses. The application period of the test is 5-15 minutes and the time factor is not evaluated separately.


Secondary Outcome Measures :
  1. Berg Balance Test [ Time Frame: 6 weeks ]
    The reliability and validity of the Turkish form was performed by Şahin et al. The Berg Balance Test was designed to assess the balance in elderly adults and to determine the risk of falling. It is performed using a five-point scale to give scores to the subjects performing the fourteen functional activities. The maximum score in the Berg Balance Test is 56.A score below 40 indicates a reduction of approximately 100%.

  2. 6 Minute Walk Test [ Time Frame: 6 weeks ]
    The 6 Minute Walk Test (6DYT) was adapted by American Thoracic Society (ATS) from the "12-Minute Cooper Test" developed by Cooper et al. It is used to evaluate the functional capacity of the person. This test measures the distance a patient can walk on a flat and hard surface for 6 minutes.

  3. Geriatric Depression Scale [ Time Frame: 6 weeks ]
    Geriatric Depression Scale was developed in 1983 by Yesavage et al. Turkish validity and reliability study was conducted in 1997 by Ertan et al. Geriatric Depression Scale consists of 30 questions based on self-report and questions are answered yes or no. Each response with a symptom of depression is evaluated as one point.

  4. Short Form 36 Quality of Life Questionnaire (SF-36) [ Time Frame: 6 weeks ]
    The SF-36 is a general health screening survey designed in America. The reliability and validity of the SF-36 were performed by Koçyiğit et al. in 50 patients with osteoarthritis and 50 patients with low back pain. Questions examine 8 different subgroups of health. It also includes the physical activity limitations perceived by the patient.

  5. Time up and Go Test [ Time Frame: 6 weeks ]
    Time up and Go Test was developed in 1991 by Diane et al. This test evaluates the risk of falling and mobility in the elderly. Time up and Go Test is a balance and gait index that requires the patient to stand up from a chair, walk 3 meters, return to the chair and sit down. The time required to complete the task is measured in seconds.

  6. Mini Mental Durum Test [ Time Frame: 6 weeks ]
    The Mini Mental Test (MMT) was developed in 1975 by Folstein. It consists of 11 questions evaluating cognitive functions such as test, recall, language, record memory, calculation, orientation. The applicability and reliability of this test has been enhanced by the Standardized Practice Guide developed by Molloy et al. The MMT is divided into two parts, the first part only requires a voice response and includes orientation, memory and attention; the highest score is 21. The second section tests name capability, follow verbal and written commands and single-handedly write the sentence . It involves copying a complex polygon similar to the Bender-Gestalt Figure. The maximum score is 9.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants between the ages of 60 and 80
  • Mini Mental Status Test score to be over 24

Exclusion Criteria:

  • Cardiovascular disease
  • Cardiovascular surgery operation, pacemaker etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878394


Contacts
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Contact: Sibel Eminoglu Tek, Msc +905352089585 sibeleminoglu@outlook.com

Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
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Study Director: Miray Budak, assoc.prof. Medipol University
Additional Information:
Publications:
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Responsible Party: Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03878394    
Other Study ID Numbers: 10840098-604.01.01-E47630
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Medipol University Hospital:
balance
cognitive function
healthy individuals
quality of life
cognitive exercises
depression