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
About this trial
This is an interventional prevention trial for Telerehabilitation focused on measuring Chronic Disease, Exercises, Social Isolation
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
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
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
Learn more about this trial
Telerehabilitation in Individuals With Chronic Disease
We'll reach out to this number within 24 hrs