Exercise ProgramNCT05580120
Online-supervised Exercise Program in Elderly People With Diabetes
A study testing Online-supervised exercise group and Unsupervised-exercise training group in people with Exercise Program and Type2diabetes, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of an online-supervised exercise program on fasting blood sugar, psychological resilience, and quality of life in elderly people with diabetes. A parallel-group, randomized controlled trial design was used. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise Program, Type2diabetes
- What is being tested?
- Online-supervised exercise group and Unsupervised-exercise training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Jul 2022
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a diagnosis of Type 2 diabetes mellitus for at least 6 months,
- Being aged >50 years,
- Receiving oral antidiabetic and/or insulin therapy,
- Having a smartphone or a computer,
- Volunteering to participate in the study,
Who cannot join
- Individuals who had type 2 DM, but were illiterate
- Had vision and hearing loss
- Did not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, 15000
About this study
Official title: The Effect of an Online-supervised Exercise Program in Elderly People With Diabetes on Fasting Blood Sugar, Psychological Resilience, and Quality of Life: A Double Blind Randomize Controlled Trial
This study was conducted to determine the effect of an online-supervised exercise program on fasting blood sugar, psychological resilience, and quality of life in elderly people with diabetes. A parallel-group, randomized controlled trial design was used. The study was conducted in a public hospital with 70 patients with elderly type 2 diabetes between Nowember 2021 and May 2022. A Personal Information Form, The Brief Resilience Scale and A Measure of Quality of Life in the Elderly were used to collect data.
- Conditions
- Exercise Program, Type2diabetes
- Being tested
- Online-supervised exercise group, Unsupervised-exercise training group
- Keywords
- psychological resilience, quality of life, distance education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online-supervised exercise groupBehavioural
Participants in the online-supervised exercise group were provided with an online-supervised exercise program by using the video conferencing method three times a week for 6 weeks on the Zoom application. The exercise program was carried out synchronously
Unsupervised-exercise training groupBehavioural
The unsupervised-exercise training group was informed about how to do the same exercises by another researcher, a nurse academician, on the online platform by using the lecturing method. Each training intervention took approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Online-supervised exercise group | Experimental | After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given online-supervised exercise education for 6 weeks. Receives: Behavioral: Online-supervised exercise group |
| The unsupervised-exercise training group | Experimental | After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given unsupervised exercise education for 6 weeks. Receives: Behavioral: Unsupervised-exercise training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Brief Resilience Scale
The scale was developed by Smith et al. to measure individuals' resilience levels and was adapted to Turkish by Doğan. It is a one-dimensional 6-item measurement tool. High scores obtained from the scale indicate that the individual's psychological resilience is good. Cronbach's alpha internal consistency coefficient of the scale is .83.
Measured: 5 minute
A Measure of Quality of Life in the Elderly
This scale was developed by Hyde et al. in 2003 to measure the quality of life of the elderly. It was adapted to Turkish society in 2014 by Türkoğlu and Adıbelli. An increase in the total score indicates an increase in the quality of life. The scale consists of two sub-dimensions, namely "perceived autonomy and satisfaction" and "perceived disability". Cronbach's alpha value of the original scale is .91.
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start15 Nov 2021
- Primary completion10 May 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exercise ProgramStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Principal investigator, Nurten Terkes, Mehmet Akif Ersoy University
- Investigators
- Sabriye Ucan Yamac, PhD, Study chair, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580120
- Sponsor's protocol ID
- GO 2021/293
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All authors contributed to the interpretation, writing, and approval of the final manuscript.
Publications
Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartin A, Sampedro-Nunez MA, Davalos A, Marazuela M. COVID-19 Lockdown and Changes of the Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. Nutrients. 2020 Aug 4;12(8):2327. doi: 10.3390/nu12082327.
PubMed 32759636Duruturk N, Ozkoslu MA. Effect of tele-rehabilitation on glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status in patients with type 2 diabetes: A double blind randomized controlled trial. Prim Care Diabetes. 2019 Dec;13(6):542-548. doi: 10.1016/j.pcd.2019.03.007. Epub 2019 Apr 20.
PubMed 31014938Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.
PubMed 33561280
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Online-supervised Exercise Program in Elderly People With Diabetes on Fasting Blood Sugar, Psychological Resilience, and Quality of Life: A Double Blind Randomize Controlled Trial
- ClinicalTrials.gov ID
- NCT05580120
- Acronym / sponsor ID
- GO 2021/293
- Conditions
- Exercise Program, Type2diabetes
- Keywords
- psychological resilience, quality of life, distance education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 14 Oct 2022 (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.
This study was conducted to determine the effect of an online-supervised exercise program on fasting blood sugar, psychological resilience, and quality of life in elderly people with diabetes. A parallel-group, randomized controlled trial design was used. The study was conducted in a public hospital with 70 patients with elderly type 2 diabetes between Nowember 2021 and May 2022. A Personal Information Form, The Brief Resilience Scale and A Measure of Quality of Life in the Elderly were used to collect data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online-supervised exercise group | Experimental | Behavioral: Online-supervised exercise groupAfter the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given online-supervised exercise education for 6 weeks. |
| The unsupervised-exercise training group | Experimental | Behavioral: Unsupervised-exercise training groupAfter the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given unsupervised exercise education for 6 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having a diagnosis of Type 2 diabetes mellitus for at least 6 months,
- Being aged >50 years,
- Receiving oral antidiabetic and/or insulin therapy,
- Having a smartphone or a computer,
- Volunteering to participate in the study,
Key exclusion criteria (3 listed)
- Individuals who had type 2 DM, but were illiterate
- Had vision and hearing loss
- Did not volunteer to participate in the study
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 |
|---|---|---|
| Online-supervised exercise groupParticipants in the online-supervised exercise group were provided with an online-supervised exercise program by using the video conferencing method three times a week for 6 weeks on the Zoom application. The exercise program was carried out synchronously | Behavioural | Online-supervised exercise group |
| Unsupervised-exercise training groupThe unsupervised-exercise training group was informed about how to do the same exercises by another researcher, a nurse academician, on the online platform by using the lecturing method. Each training intervention took approximately 30 minutes. | Behavioural | The unsupervised-exercise training group |
Primary outcome
The Brief Resilience Scale
Time frame: 5 minute
The scale was developed by Smith et al. to measure individuals' resilience levels and was adapted to Turkish by Doğan. It is a one-dimensional 6-item measurement tool. High scores obtained from the scale indicate that the individual's psychological resilience is good. Cronbach's alpha internal consistency coefficient of the scale is .83.
A Measure of Quality of Life in the Elderly
Time frame: 5 minute
This scale was developed by Hyde et al. in 2003 to measure the quality of life of the elderly. It was adapted to Turkish society in 2014 by Türkoğlu and Adıbelli. An increase in the total score indicates an increase in the quality of life. The scale consists of two sub-dimensions, namely "perceived autonomy and satisfaction" and "perceived disability". Cronbach's alpha value of the original scale is .91.
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 Oct 2022.
- Results publication: PubMed 32759636Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartin A, Sampedro-Nunez MA, Davalos A, Marazuela M. COVID-19 Lockdown and Changes of the Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. Nutrients. 2020 Aug 4;12(8):2327. doi: 10.3390/nu12082327.
- Results publication: PubMed 31014938Duruturk N, Ozkoslu MA. Effect of tele-rehabilitation on glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status in patients with type 2 diabetes: A double blind randomized controlled trial. Prim Care Diabetes. 2019 Dec;13(6):542-548. doi: 10.1016/j.pcd.2019.03.007. Epub 2019 Apr 20.
- Results publication: PubMed 33561280Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.
- Individual participant dataSharing planned: No. All authors contributed to the interpretation, writing, and approval of the final manuscript.
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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.
Sabriye Ucan Yamac, PhD study chair
Burdur Mehmet Akif Ersoy 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 Online-supervised exercise group and Unsupervised-exercise training group in people with Exercise Program and Type2diabetes, run by Mehmet Akif Ersoy 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 5 inclusion and 3 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 Oct 2022. 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?
The Brief Resilience Scale (time frame: 5 minute). 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?
On the ClinicalTrials.gov record for NCT05580120, which also lists 3 linked publications.
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 Oct 2022.