AgingNCT06548880
Effectiveness of Online Exercise Training in Geriatric Population During COVID-19
A study testing Structured exercise program in people with Aging and Falling, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of online exercise training in geriatric population whose daily life activity level decreased during COVID-19 pandemic. The main questions it aims to answer are: Does online exercise training improve quality of life in the geriatric population whose daily life… Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Falling, Dependence
- What is being tested?
- Structured exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 31 Aug 2023
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Volunteering to participate in the study
- Being over 65 years old
Who cannot join
- Having mental retardation at a level that prevents communication
- Having an uncontrollable heart and hypertension problem
- Being receiving medical treatment or rehabilitation for balance that may affect the balance level
- Having osteoporosis at a level where exercise can be considered risky
- Having a health problem where exercise is considered contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Online Exercise Training in Geriatric Population Whose Daily Life Activity Level Decreased During COVID-19 Pandemic
The aim of this study is to investigate the effectiveness of online exercise training in geriatric population whose daily life activity level decreased during COVID-19 pandemic.
The main questions it aims to answer are:
Read more
- Does online exercise training improve quality of life in the geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training improve sleep quality in the geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training affect depression status in the geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training reduce the risk of falls by improving balance and functional independence in geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training improve posture in geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
Research data were collected by Sociodemographic Information Form, 36-Item Short Form Survey, The Pittsburgh Sleep Quality Index, Geriatric Depression Scale, Timed Up \& Go Test, and New York Posture Rating Chart.
While no application was given to the control group, study group has received an online exercise training with a structured exercise program including range of motion, stretching, and, to train full body, low intensity aerobic exercises, once a week for 10 weeks, each lasting 60 minutes.
- Conditions
- Aging, Falling, Dependence, Inactivity, Physical
- Being tested
- Structured exercise program
- Keywords
- COVID-19, activities of daily living, geriatrics, telerehabilitation
- Medical subject headings
- Sedentary Behavior, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exercise programOther
The intervention applied in this research has an online exercise training conducting with a structured exercise program including different types of exercise which are range of motion, stretching and low intensity aerobic exercises. The exercise program continued with sessions each lasting 60 minutes, once a week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Participants in the study group have received an online exercise training with a structured exercise program including range of motion, stretching, and, to train full body, low intensity aerobic exercises, once a week for 10 weeks, each lasting 60 minutes. Receives: Other: Structured exercise program |
| Control group | No intervention | Participants in the control group were asked to maintain their daily physical activity routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance
To determine fall risk and measure the progress of balance, sit to stand and walking, Timed-Up and Go Test was used. This is a simple screening test that is a sensitive and specific measure of probability for falls among older adults. An older adult who takes ≥12 seconds to complete the test is at risk for falling. The results of the Timed-Up and Go Test were obtained in seconds. This primary outcome was evaluated by interpreting these results.
Measured: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
mobility
To determine fall risk and measure the progress of balance, sit to stand and walking, Timed-Up and Go Test was used. This is a simple screening test that is a sensitive and specific measure of probability for falls among older adults. An older adult who takes ≥12 seconds to complete the test is at risk for falling. The results of the Timed-Up and Go Test were obtained in seconds. This primary outcome was evaluated by interpreting these results.
Measured: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
Secondary outcomes (4)
sleep quality
This outcome was evaluated by The Pittsburgh Sleep Quality Index. This is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
depression status
This outcome was evaluated by Geriatric Depression Scale. According to the results of this questionnaire, a higher score is considered an indicator of more severe depression.
Measured: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
posture
This outcome was evaluated by New York Posture Rating Chart. This test includes a set of three figure drawings for each of different body alignment segments contributing to overall postural alignment. According to the results of this test, a higher score is considered an indicator of good posture.
Measured: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
QoL
This outcome was evaluated by 36-Item Short Form Survey. This questionnaire evaluates 8 basic concepts related to health with 36 questions. Item scores for each quality of life area are coded and placed on a scale of 0-100 (0 is the worst, 100 is the best) using algorithms.
Measured: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Apr 2022
- Primary completion31 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 10 participants were included in the study group, and 10 participants were included in the control group.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Gedik University
- Responsible party
- Principal investigator, Sıla YILMAZ, Medipol University
- Investigators
- Gönül ERTUNÇ GÜLÇELİK, Ph.D., Study chair, Kocaeli UniversitySıla YILMAZ, M.Sc., Study director, Medipol UniversityFatma Nur DÜLGER, Miss, Principal investigator, Medipol UniversityElvan EKİNCİ, Miss, Principal investigator, İstanbul Gedik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548880
- Sponsor's protocol ID
- E-714577430500104202121124-255
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Online Exercise Training in Geriatric Population Whose Daily Life Activity Level Decreased During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT06548880
- Acronym / sponsor ID
- E-714577430500104202121124-255
- Conditions
- Aging, Falling, Dependence, Inactivity, Physical
- Keywords
- COVID-19, activities of daily living, geriatrics, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Istanbul Gedik University
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Aug 2024 (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.
The aim of this study is to investigate the effectiveness of online exercise training in geriatric population whose daily life activity level decreased during COVID-19 pandemic.
The main questions it aims to answer are:
- Does online exercise training improve quality of life in the geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training improve sleep quality in the geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training affect depression status in the geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training reduce the risk of falls by improving balance and functional independence in geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
- Does online exercise training improve posture in geriatric population whose daily life activity levels have decreased during the COVID-19 pandemic?
Research data were collected by Sociodemographic Information Form, 36-Item Short Form Survey, The Pittsburgh Sleep Quality Index, Geriatric Depression Scale, Timed Up \& Go Test, and New York Posture Rating Chart.
While no application was given to the control group, study group has received an online exercise training with a structured exercise program including range of motion, stretching, and, to train full body, low intensity aerobic exercises, once a week for 10 weeks, each lasting 60 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 participants were included in the study group, and 10 participants were included in the control group.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Structured exercise programParticipants in the study group have received an online exercise training with a structured exercise program including range of motion, stretching, and, to train full body, low intensity aerobic exercises, once a week for 10 weeks, each lasting 60 minutes. |
| Control group | No intervention | –Participants in the control group were asked to maintain their daily physical activity routine. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Volunteering to participate in the study
- Being over 65 years old
Key exclusion criteria (5 listed)
- Having mental retardation at a level that prevents communication
- Having an uncontrollable heart and hypertension problem
- Being receiving medical treatment or rehabilitation for balance that may affect the balance level
- Having osteoporosis at a level where exercise can be considered risky
- Having a health problem where exercise is considered contraindicated
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 |
|---|---|---|
| Structured exercise programThe intervention applied in this research has an online exercise training conducting with a structured exercise program including different types of exercise which are range of motion, stretching and low intensity aerobic exercises. The exercise program continued with sessions each lasting 60 minutes, once a week for 10 weeks. | Other | Study group |
Primary outcome
balance
Time frame: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
To determine fall risk and measure the progress of balance, sit to stand and walking, Timed-Up and Go Test was used. This is a simple screening test that is a sensitive and specific measure of probability for falls among older adults. An older adult who takes ≥12 seconds to complete the test is at risk for falling. The results of the Timed-Up and Go Test were obtained in seconds. This primary outcome was evaluated by interpreting these results.
mobility
Time frame: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
To determine fall risk and measure the progress of balance, sit to stand and walking, Timed-Up and Go Test was used. This is a simple screening test that is a sensitive and specific measure of probability for falls among older adults. An older adult who takes ≥12 seconds to complete the test is at risk for falling. The results of the Timed-Up and Go Test were obtained in seconds. This primary outcome was evaluated by interpreting these results.
4 secondary outcomes
sleep quality
Time frame: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
depression status
Time frame: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
posture
Time frame: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
QoL
Time frame: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.
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 14 Jan 2025.
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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.
Gönül ERTUNÇ GÜLÇELİK, Ph.D. study chair
Kocaeli University
Sıla YILMAZ, M.Sc. study director
Medipol University
Fatma Nur DÜLGER, Miss principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise program in people with Aging and Falling, run by Medipol University 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 2 inclusion and 5 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 14 Jan 2025. 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?
balance (time frame: This outcome was evaluated twice, before starting the exercise program and after completing the exercise program.). The study lists 2 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 14 Jan 2025.