TelerehabilitationNCT04346940
The Effectiveness of Telerehabilitation-Based Exercises in Elderly People
A study testing Telerehabilitation and Exercise brochure in people with Telerehabilitation and Elderly People, run by Istinye University.
Trial summary
An epidemic of pneumonia , which is thought to have developed due to a new coronavirus, was detected in Wuhan, Hubei Province of the People's Republic of China, and this epidemic could not be brought under control, leading to other provinces of China in a short time and then to a pandemic. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Telerehabilitation, Elderly People, Social Isolation
- What is being tested?
- Telerehabilitation and Exercise brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 65 and over,Mini Mental Status Scale 24 and above, To be able to communicate verbally and visually,Those who do not have serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) that may prevent exercise,Having the necessary technological competence to provide remote video communication at home,To be at least 20 m ambassador
Who cannot join
- Mini Mental Status Scale being lower than 24,Those with serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) that may interfere with exercise,Visual or auditory loss
About this study
Official title: The Effectiveness of Telerehabilitation-Based Exercises in Elderly People Under Social Isolation Process Due to Coronavirus
An epidemic of pneumonia , which is thought to have developed due to a new coronavirus, was detected in Wuhan, Hubei Province of the People's Republic of China, and this epidemic could not be brought under control, leading to other provinces of China in a short time and then to a pandemic. It has spread all over the world including the European continent. Causative Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) and the disease caused by the new virus (novel) coronavirus-2019 (2019-nCoV) and subsequently the COVID-19. After the virus was officially detected in our country on 11 March 2020, the number of cases increased rapidly and the virus was isolated in 670 patients within 10 days. The group that is most affected by the outbreak and has the highest mortality rate is the elderly with known cardiovascular diseases. It is important to ensure the social isolation of elderly patients and to minimize all hospital applications as much as possible if they do not have life-threatening urgent problems. To this end, Turkey on 21 March 2020, 65 years of age and older people and patients with chronic curfew was implemented.
Individuals moving away from social life are dealing with their body more, their level of depression and anxiety increase, and their physical functions decrease. The therapy service is offered to people who cannot travel with telerehabilitation, which is defined as the transmission of rehabilitation service to long distances by using electronic information and communication technology.
The purpose of this study is to investigate the effects of telerehabilitation exercises given to elderly individuals on sleep quality, quality of life and balance within the scope of geriatric rehabilitation.
- Conditions
- Telerehabilitation, Elderly People, Social Isolation
- Being tested
- Telerehabilitation, Exercise brochure
- Keywords
- COVID-19, Exercise
- Medical subject headings
- Social Isolation, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
15 volunteers aged 65 and over will be included in this group. An online exercise program has been created for individuals who will participate in the study. It is planned that this program will continue for 3 days a week, 6 weeks, and the duration of exercise will reach 45 minutes in the last week due to the increase in the number of repetitions about 30 minutes at the beginning. The treatment sessions will start with warm-up exercises, complete with posture exercises, joint range of motion exercises, stretching exercises, and cool-down exercises in the main program.
Exercise brochureOther
The same exercises will be given to the control group as a brochure and they will be asked to do it for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The group to which the exercise protocol consisting of chair-based exercises will be applied. Receives: Other: Telerehabilitation |
| Control Group | Active comparator | Group to be given an exercise brochure Receives: Other: Exercise brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental Test
Screening test in which cognitive functions are evaluated globally. With standardized mini mental test, the patient is evaluated under 5 main topics. The patient receives a maximum of 30 minimum 0 points at the end of the test. The critical score here is 27 or 24. It is decided that patients scoring below 24 have cognitive impairment. In some cases, the limit is considered to be 27 points.
Measured: 2 weeks
Mini Nutritional Assesment
The Mini Nutritional Assessment (MNA) has recently been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. sum of the MNA score distinguishes between elderly patients with: 1) adequate nutritional status, MNA ≥ 24; 2) protein-calorie malnutrition, MNA < 17; 3) at risk of malnutrition, MNA between 17 and 23.5.
Measured: 2 weeks
Short Physical Performance Test
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. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.
Measured: 2 weeks
Single Leg Stance Test
The one-leg standing (OLS) test is one of the balance tests used to diagnose musculoskeletal ambulation disability symptom complex (MARS), a condition newly defined by three professional Japanese medical societies in 2006 to help identify the symptoms of motor organ deterioration and establish preventive strategies. Although many studies have used the OLS test, none has shown conclusively that the test can be used as a practical marker of frailty among elderly people, especially in community settings.
Measured: 2 weeks
Charlson Comorbidity Index
Scaling that can be applied with the informer or by obtaining information from the medical records in order to quantify the comorbidities and to examine their effects on prognosis in clinical studies. 19 disease states are evaluated.
Measured: 2 weeks
Clinic Fragility Scale
A multi-dimensional loss of reserve that leads to fragility, fragility (energy, physical ability, cognition,health) syndrome and weakness 3 or more symptoms (unintentional weight loss, feeling tired, weak grip, slow walking rate and low physical activity), the person can be described as we It consists of 9 questions.If there are 3 or more symptoms (unintentional weight loss, fatigue, poor grip, slow walking speed, and low physical activity), the person can be described as weak.
Measured: 2 weeks
Pittsburgh Sleep Quality Index
It is a scale evaluating sleep quality with a total of 19 questions under 7 main topics. Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report scale that evaluates sleep quality and disorder in the past month The total score of the 7 components gives the scale total score. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality".
Measured: 2 weeks
Social Isolation Survey
Social participation levels were evaluated with the Social Isolation Survey. Minimum 0 and maximum 24 points are obtained from the scale. 0 points indicate complete social isolation while 24 points indicate high social relationship. A value of 0-10 indicates complete social isolation, 12-15 isolation, 16-18 partial isolation, 19-21 social, 21-24 high social relationship Quality of life scale in the elderly
Measured: 2 weeks
Quality of life scale in the elderly
The Quality of life scale in the elderly (CASP-19) was developed in 2003 to measure.The scale consists of 19 items and "Control", "Autonomy", "Pleasure" and "Self-realization." Each item of the original scale is "never" (0 score) to "always" (3 points) It is rated as a 4-point Likert type. The increase in the total score indicates that the quality of life increases.
Measured: 2 weeks
The Physical Activity Scale for the Elderly
Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of persons age 65 years and older. The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.
Measured: 2 weeks
Timed Up and Go Test
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require
Measured: 2 weeks
30 Second Chair Stand Test
The 30-s Chair Stand Test (CST) consists of standing up and sitting down from a chair as many times as possible within 30 seconds. A standard chair without backrest, but with armrests is used. Initially, the person is seated on the chair with his backs upright. They are told to look forward with their arms folded in their chest and rise at their preferred speed after the command "1, 2, 3, go". All trials must be carried out using the same chair and similar environmental conditions.
Measured: 2 weeks
The Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Two subscales include a cognitive-affective subscale and a somatic-performance subscale.
Measured: 2 weeks
The Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) 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 . It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start10 Aug 2020 (estimated)
- Primary completion10 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346940
- Sponsor's protocol ID
- 007
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Telerehabilitation-Based Exercises in Elderly People Under Social Isolation Process Due to Coronavirus
- ClinicalTrials.gov ID
- NCT04346940
- Acronym / sponsor ID
- 007
- Conditions
- Telerehabilitation, Elderly People, Social Isolation
- Keywords
- COVID-19, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Aug 2020 (estimated)
- Primary completion
- 10 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An epidemic of pneumonia , which is thought to have developed due to a new coronavirus, was detected in Wuhan, Hubei Province of the People's Republic of China, and this epidemic could not be brought under control, leading to other provinces of China in a short time and then to a pandemic. It has spread all over the world including the European continent. Causative Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) and the disease caused by the new virus (novel) coronavirus-2019 (2019-nCoV) and subsequently the COVID-19. After the virus was officially detected in our country on 11 March 2020, the number of cases increased rapidly and the virus was isolated in 670 patients within 10 days. The group that is most affected by the outbreak and has the highest mortality rate is the elderly with known cardiovascular diseases. It is important to ensure the social isolation of elderly patients and to minimize all hospital applications as much as possible if they do not have life-threatening urgent problems. To this end, Turkey on 21 March 2020, 65 years of age and older people and patients with chronic curfew was implemented.
Individuals moving away from social life are dealing with their body more, their level of depression and anxiety increase, and their physical functions decrease. The therapy service is offered to people who cannot travel with telerehabilitation, which is defined as the transmission of rehabilitation service to long distances by using electronic information and communication technology.
The purpose of this study is to investigate the effects of telerehabilitation exercises given to elderly individuals on sleep quality, quality of life and balance within the scope of geriatric rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: TelerehabilitationThe group to which the exercise protocol consisting of chair-based exercises will be applied. |
| Control Group | Active comparator | Other: Exercise brochureGroup to be given an exercise brochure |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals aged 65 and over,Mini Mental Status Scale 24 and above, To be able to communicate verbally and visually,Those who do not have serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) that may prevent exercise,Having the necessary technological competence to provide remote video communication at home,To be at least 20 m ambassador
Key exclusion criteria (1 listed)
- Mini Mental Status Scale being lower than 24,Those with serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) that may interfere with exercise,Visual or auditory loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation15 volunteers aged 65 and over will be included in this group. An online exercise program has been created for individuals who will participate in the study. It is planned that this program will continue for 3 days a week, 6 weeks, and the duration of exercise will reach 45 minutes in the last week due to the increase in the number of repetitions about 30 minutes at the beginning. The treatment sessions will start with warm-up exercises, complete with posture exercises, joint range of motion exercises, stretching exercises, and cool-down exercises in the main program. | Other | Study Group |
| Exercise brochureThe same exercises will be given to the control group as a brochure and they will be asked to do it for 6 weeks. | Other | Control Group |
Primary outcome
Standardized Mini Mental Test
Time frame: 2 weeks
Screening test in which cognitive functions are evaluated globally. With standardized mini mental test, the patient is evaluated under 5 main topics. The patient receives a maximum of 30 minimum 0 points at the end of the test. The critical score here is 27 or 24. It is decided that patients scoring below 24 have cognitive impairment. In some cases, the limit is considered to be 27 points.
Mini Nutritional Assesment
Time frame: 2 weeks
The Mini Nutritional Assessment (MNA) has recently been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. sum of the MNA score distinguishes between elderly patients with: 1) adequate nutritional status, MNA ≥ 24; 2) protein-calorie malnutrition, MNA < 17; 3) at risk of malnutrition, MNA between 17 and 23.5.
Short Physical Performance Test
Time frame: 2 weeks
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. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.
Single Leg Stance Test
Time frame: 2 weeks
The one-leg standing (OLS) test is one of the balance tests used to diagnose musculoskeletal ambulation disability symptom complex (MARS), a condition newly defined by three professional Japanese medical societies in 2006 to help identify the symptoms of motor organ deterioration and establish preventive strategies. Although many studies have used the OLS test, none has shown conclusively that the test can be used as a practical marker of frailty among elderly people, especially in community settings.
Charlson Comorbidity Index
Time frame: 2 weeks
Scaling that can be applied with the informer or by obtaining information from the medical records in order to quantify the comorbidities and to examine their effects on prognosis in clinical studies. 19 disease states are evaluated.
Clinic Fragility Scale
Time frame: 2 weeks
A multi-dimensional loss of reserve that leads to fragility, fragility (energy, physical ability, cognition,health) syndrome and weakness 3 or more symptoms (unintentional weight loss, feeling tired, weak grip, slow walking rate and low physical activity), the person can be described as we It consists of 9 questions.If there are 3 or more symptoms (unintentional weight loss, fatigue, poor grip, slow walking speed, and low physical activity), the person can be described as weak.
Pittsburgh Sleep Quality Index
Time frame: 2 weeks
It is a scale evaluating sleep quality with a total of 19 questions under 7 main topics. Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report scale that evaluates sleep quality and disorder in the past month The total score of the 7 components gives the scale total score. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality".
Social Isolation Survey
Time frame: 2 weeks
Social participation levels were evaluated with the Social Isolation Survey. Minimum 0 and maximum 24 points are obtained from the scale. 0 points indicate complete social isolation while 24 points indicate high social relationship. A value of 0-10 indicates complete social isolation, 12-15 isolation, 16-18 partial isolation, 19-21 social, 21-24 high social relationship Quality of life scale in the elderly
Quality of life scale in the elderly
Time frame: 2 weeks
The Quality of life scale in the elderly (CASP-19) was developed in 2003 to measure.The scale consists of 19 items and "Control", "Autonomy", "Pleasure" and "Self-realization." Each item of the original scale is "never" (0 score) to "always" (3 points) It is rated as a 4-point Likert type. The increase in the total score indicates that the quality of life increases.
The Physical Activity Scale for the Elderly
Time frame: 2 weeks
Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of persons age 65 years and older. The overall PASE score ranges from 0 to 400 or more and high scores show better physical activity levels.
Timed Up and Go Test
Time frame: 2 weeks
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require
30 Second Chair Stand Test
Time frame: 2 weeks
The 30-s Chair Stand Test (CST) consists of standing up and sitting down from a chair as many times as possible within 30 seconds. A standard chair without backrest, but with armrests is used. Initially, the person is seated on the chair with his backs upright. They are told to look forward with their arms folded in their chest and rise at their preferred speed after the command "1, 2, 3, go". All trials must be carried out using the same chair and similar environmental conditions.
The Beck Depression Inventory
Time frame: 2 weeks
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Two subscales include a cognitive-affective subscale and a somatic-performance subscale.
The Beck Anxiety Inventory
Time frame: 2 weeks
The Beck Anxiety Inventory (BAI) 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 . It is designed for individuals who are of 17 years of age or older and takes 5 to 10 minutes to complete. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Telerehabilitation
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Exercise brochure in people with Telerehabilitation and Elderly People, run by Istinye University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Mini Mental Test (time frame: 2 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.