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Telerehabilitation in Individuals With Chronic Disease

Primary Purpose

Telerehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telerehabilitation
Exercise brochure
Sponsored by
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Telerehabilitation focused on measuring Chronic Disease, Exercises, Social Isolation

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having a chronic disease
  • To be able to communicate verbally
  • Being in a stable period in terms of disease
  • At least 3 months for the disease to be chronic
  • Regulated hypertension
  • Diabetes patients should have them blood sugar under 200 during therapy

Exclusion Criteria:

  • Dementia
  • Being a cancer patient receiving chemotherapy
  • Epilepsy and a history of seizures
  • Patient who has recently undergone surgery
  • Pregnancy
  • Delirium
  • Bedridden

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Study Group

    Control Group

    Arm Description

    Individual exercises will be applied to individuals with Chronic disease.

    Group to be given an exercise brochure

    Outcomes

    Primary Outcome Measures

    Beck Depression Inventory
    The Beck Depression Inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Beck Depression Inventory is a 21-question multiple-choice self-report inventory The Beck Depression Inventory takes approximately 10 minutes to complete. The minimum score that can be obtained from the scale is 0 and the maximum score is 63 . Higher total scores indicate more severe depressive symptoms.

    Secondary Outcome Measures

    Charlson Comorbidity Index
    The Charlson Comorbidity Index is a method of categorizing comorbidities of patients. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.

    Full Information

    First Posted
    July 20, 2020
    Last Updated
    July 28, 2020
    Sponsor
    Istinye University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04484389
    Brief Title
    Telerehabilitation in Individuals With Chronic Disease
    Official Title
    Effects of Exercise With Telerehabilitation on Depression, Quality of Life and Fatigue in Individuals With Chronic Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 15, 2020 (Anticipated)
    Primary Completion Date
    August 15, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istinye University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Telerehabilitation applications are a treatment method that uses new technologies. There are examples of doing for many diseases in our country. It is a method used for people living in remote areas and people who cannot complete their treatment in hospitals due to the epidemic. In our study, we will use the telerehabilitation system. In this system, which we will use in people with chronic disease, we aim to see improvement in tests performed in many areas such as physical activity level, respiratory capacity, depression, and anxiety level of patients. In the study to be performed on 60 patients, 30 people will be control and 30 people will be the experimental group. The experimental group will be treated with a video conferencing method, tailor-made exercise program based on the international physical activity questionnaire level for 30 minutes 3 days a week for 6 weeks. The control group will only be informed with the help of a brochure with a standard exercise program. The tests we can use in this experiment are as follows: Barthel daily life activities index, beck depression and anxiety scale, ferrans power quality of life index, Charlson comorbidity index, environmental measurements, waist/hip ratio, fatigue severity scale, international physical activity questionnaire. Tests specific to chronic diseases will be applied to patient one to one.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Telerehabilitation
    Keywords
    Chronic Disease, Exercises, Social Isolation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Single
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    Individual exercises will be applied to individuals with Chronic disease.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Group to be given an exercise brochure
    Intervention Type
    Other
    Intervention Name(s)
    Telerehabilitation
    Intervention Description
    Exercise protocol according to Ipaq will be prepared for 30 patients with chronic disease . Exercise protocol; warm-up exercises include, stretching exercises, postural exercises, aerobic exercise and cooling exercises. People will practice the exercises 3 days a week for 6 weeks. People will need to reserve 30 minutes a day for this study.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise brochure
    Intervention Description
    General exercise protocol will be prepared and given to the control group as a brochure
    Primary Outcome Measure Information:
    Title
    Beck Depression Inventory
    Description
    The Beck Depression Inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Beck Depression Inventory is a 21-question multiple-choice self-report inventory The Beck Depression Inventory takes approximately 10 minutes to complete. The minimum score that can be obtained from the scale is 0 and the maximum score is 63 . Higher total scores indicate more severe depressive symptoms.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Charlson Comorbidity Index
    Description
    The Charlson Comorbidity Index is a method of categorizing comorbidities of patients. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.
    Time Frame
    2 weeks
    Other Pre-specified Outcome Measures:
    Title
    The Beck Anxiety Inventory
    Description
    The Beck Anxiety Inventory is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The questions used in this measure ask about common symptoms of anxiety that the subject has had during the past week (including the day you take it) (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. The minimum score that can be obtained from the scale is 0 and the maximum score is 63.
    Time Frame
    2 weeks
    Title
    MODIFIED FATIGUE IMPACT SCALE
    Description
    The Modified Fatigue Impact Scale is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items. The minimum score that can be obtained from the scale is 0 and the maximum score is 84.
    Time Frame
    2 weeks
    Title
    The Fatigue Severity Scale
    Description
    The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer.
    Time Frame
    2 weeks
    Title
    Ferrans and Powers quality of life index
    Description
    The subjective perception of the level of happiness and satisfaction towards the different aspects of life is considered the main determinant in making a positive or negative judgment of the subjectively perceived quality of life. The current generic version of the Ferrans and Powers Quality of Life Index consists of 33 items in each part, which the subjects attribute scores in a satisfaction. The 33 items are distributed into the four dimensions (subscales): Health/functioning (13 items), Social and economic (8 items), Psychological/spiritual (7 items) and Family (5 items). The minimum score that can be obtained from the scale is 0 and the maximum score is 30.
    Time Frame
    2 weeks
    Title
    Chest Circumference Measurement
    Description
    Standing, it is measured by arms in abduction. It passes through the lower end of the scapula on the back and is measured at the level of the 4th rib.
    Time Frame
    2 weeks
    Title
    Waist to Hip Ratio
    Description
    It is the ratio of waist circumference to hip circumference. By measuring this value for scientific studies, it examines the risk level of potential health problems that individuals may encounter in the future. According to the studies of scientists, it shows quite accurate results about the risk of an individual having a health problem because it shows in which part of the body the excess weight is collected.
    Time Frame
    2 weeks
    Title
    INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE
    Description
    The International Physical Activity Questionnaires comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. 1998 and was followed by extensive reliability and validity testing undertaken across 12 countries (14 sites) . Physical Activity level is determined in 3 categories
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having a chronic disease To be able to communicate verbally Being in a stable period in terms of disease At least 3 months for the disease to be chronic Regulated hypertension Diabetes patients should have them blood sugar under 200 during therapy Exclusion Criteria: Dementia Being a cancer patient receiving chemotherapy Epilepsy and a history of seizures Patient who has recently undergone surgery Pregnancy Delirium Bedridden

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Telerehabilitation in Individuals With Chronic Disease

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