TelerehabilitationNCT04334434
Telerehabilitation in Individuals Over 65 Years of Age Having Social Isolation Due to Coronavirus (Covid-19)
A study testing Telerehabilitation in people with Telerehabilitation, run by Kubra Koce, MSc PT at 1 site in Turkey (Türkiye).
Trial summary
In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2020to 15 Dec 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years old and over
- Being in social isolation due to the coronavirus epidemic.
- Spending at least 1 week at home different from routine life.
- Not to be obstructed from doing physical activities.
- To have access to online exercise training.
Who cannot join
- Having a serious cognitive impairment
- Having serious hearing and vision problems
- Having vestibular disorders that can cause loss of balance
- Having diabetes, hypertension or a neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation Of The Effectiveness Of The Telerehabilitation Applied To Individuals Over The Age Of 65 Who Experience Social Isolation At Houses Due To The Coronavirus (Covid-19) Pandemic
In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. This virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared it as "pandemic". Staying home and social isolation are at the top of these precautions. For this purpose, in Turkey on March 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. However, not leaving the house and social isolation brings with it the limitation of physical activity. Physical activity (PA) is defined by WHO as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. Recommended PA levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. Studies investigating the relationship between social isolation and health behavior report consistent findings. Individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. Practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. When today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. The purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the COVID-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.
- Conditions
- Telerehabilitation
- Being tested
- Telerehabilitation
- Keywords
- Covid-19, Exercises, Social Isolation
- Medical subject headings
- COVID-19, Motor Activity, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
15 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. An online exercise protocol was created for individuals who will participate in the study. Each exercise session was planned as 30 minutes for 3 days a week for 4 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic and strengthening exercises. Individuals were asked to participate in the study via Skype and aimed to do their exercises with a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The group to which the exercise protocol consisting of aerobic and strengthening exercises will be applied. Receives: Other: Telerehabilitation |
| Control Group | No intervention | Control group where evaluations will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Scale for the Elderly
One of the evaluation parameters created to evaluate the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile is the Physical Activity Scale for the Elderly. The minimum score that can be obtained from the scale is 0 and the maximum score is 400. The higher score on the scale indicates a better level of physical activity.
Measured: 2 weeks
Nottingham Health Profile
Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities.
Measured: 2 weeks
Loneliness Scale for the Elderly
It was created by Gierveld and Kamphuis in 1985 to evaluate the sense of loneliness in older individuals and was revised in 1999 by Tilburg and Gierveld. It consists of 11 items in total and two subtitles.
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 posted6 Apr 2020
- Study start30 Jul 2020
- Primary completion15 Sep 2020
- Study completion15 Dec 2020
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubra Koce, MSc PT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra Koce, MSc PT, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334434
- Sponsor's protocol ID
- 002
- Status last verified
- Jan 2021
- First submitted
- 2 Apr 2020
- Last updated
- 3 Feb 2021
- 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 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effectiveness Of The Telerehabilitation Applied To Individuals Over The Age Of 65 Who Experience Social Isolation At Houses Due To The Coronavirus (Covid-19) Pandemic
- ClinicalTrials.gov ID
- NCT04334434
- Acronym / sponsor ID
- 002
- Conditions
- Telerehabilitation
- Keywords
- Covid-19, Exercises, Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kubra Koce, MSc PTUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 6 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.
In December 2019, new coronavirus pneumonia (COVID-19) erupted in Wuhan (Hubei, China) and quickly spread from a single city to the entire country in just 30 days and then attracted worldwide attention. COVID-19 causes a large number of deaths due to its occurrence in many cases. This virus caused a total of 549,461 approved cases and 24,887 deaths worldwide. All the countries of the world take some precautions to prevent the spread of this epidemic disease, which WHO declared it as "pandemic". Staying home and social isolation are at the top of these precautions. For this purpose, in Turkey on March 21, 2020, '65 and older individuals began to apply the curfew to individuals with chronic illnesses. However, not leaving the house and social isolation brings with it the limitation of physical activity. Physical activity (PA) is defined by WHO as any bodily movement produced by the contraction of skeletal muscles that increases energy consumption. Recommended PA levels for the elderly (≥65 years) are similar to adults (18 to 64 years old). At the global level, approximately 45% of people over the age of 60 do not meet the recommended level of PA. Studies investigating the relationship between social isolation and health behavior report consistent findings. Individuals with smaller social networks report less healthy diets, excessive alcohol consumption, and less physical activity. The effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. The decrease in physical performance is associated with the risk of falling, sarcopenia, fragility, decreased quality of life, emotionalization, comorbidity, early death, and increased health care costs. Practical and innovative interventions are needed to reduce the decline in muscle mass, strength and physical performance in the aging population. When today's conditions are evaluated, technology-supported education programs are effective in increasing the motivation for physical activity. The purpose of this study; to evaluate the physical activity level of individuals over the age of 65 who experience social isolation due to the precautions taken in our country to prevent the spread of the COVID-19 pandemic, and to investigate the effectiveness of home-based telerehabilitation exercises. It is aimed to use an innovative model based on the digitally supported, home-based exercise program.
Study design
- Primary purpose
- Prevention
- 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 aerobic and strengthening exercises will be applied. |
| Control Group | No intervention | –Control group where evaluations will be made. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Being 65 years old and over
- Being in social isolation due to the coronavirus epidemic.
- Spending at least 1 week at home different from routine life.
- Not to be obstructed from doing physical activities.
- To have access to online exercise training.
Key exclusion criteria (4 listed)
- Having a serious cognitive impairment
- Having serious hearing and vision problems
- Having vestibular disorders that can cause loss of balance
- Having diabetes, hypertension or a neurological disease
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 over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. An online exercise protocol was created for individuals who will participate in the study. Each exercise session was planned as 30 minutes for 3 days a week for 4 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic and strengthening exercises. Individuals were asked to participate in the study via Skype and aimed to do their exercises with a physiotherapist | Other | Study Group |
Primary outcome
Physical Activity Scale for the Elderly
Time frame: 2 weeks
One of the evaluation parameters created to evaluate the physical activity level of elderly individuals, the factors affecting the activity level, the relationship between physical activity and health profile is the Physical Activity Scale for the Elderly. The minimum score that can be obtained from the scale is 0 and the maximum score is 400. The higher score on the scale indicates a better level of physical activity.
Nottingham Health Profile
Time frame: 2 weeks
Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities.
Loneliness Scale for the Elderly
Time frame: 2 weeks.
It was created by Gierveld and Kamphuis in 1985 to evaluate the sense of loneliness in older individuals and was revised in 1999 by Tilburg and Gierveld. It consists of 11 items in total and two subtitles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Telerehabilitation, run by Kubra Koce, MSc PT at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical Activity Scale for the Elderly (time frame: 2 weeks). The study lists 3 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 3 Feb 2021.