Comparison of the Effectiveness of Different Home Exercise Programs

January 28, 2022 updated by: Istanbul Medipol University Hospital

Comparison of the Effectiveness of Different Home Exercise Programs in Healthy Individuals

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • İstanbul
      • Beykoz, İstanbul, Turkey, 34810_
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Miray Budak, assoc.prof., Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 18, 2019

Primary Completion (ACTUAL)

January 27, 2020

Study Completion (ACTUAL)

February 3, 2020

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (ACTUAL)

March 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 10840098-604.01.01-E47630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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